DPY S ROM Noiles Rotating Hinge Surgical Technique 0612 85 510
2014-03-27
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® S-ROM NOILES ROTATING HINGE SURGICAL TECHNIQUE ™ TABLE OF CONTENTS SURGICAL TECHNIQUE Key Surgical Steps Summary 4 S-ROM® Noiles™ Rotating Hinge Knee System 6 The S-ROM Hinge System Overview 7 Incision and Exposure 8 Intra-operative Evaluation 10 Initial Preparation of the Tibia 11 Preparation of the Metaphyseal Bone – Tapered Reamer 13 Proximal Tibial Resection – Tapered Reamer 14 Preparation of the Metaphyseal Bone – Broach 16 Tibial Trial Assembly 18 Preparation of Femoral Diaphysis 19 Reaming the Medullary Canal 20 Preparation of the Metaphysis – Sleeve Use 22 Femoral Preparation – Distal Resection 26 Femoral A/P and Chamfer Cuts 29 Femoral Box Cuts 31 Final Preparation of the Tibia 32 Femoral Trial Insertion 33 Trial Reduction 36 Implant Assembly – Tibia 37 Tibial Implantation 38 Implant Assembly – Sleeve and Stem Use 39 Bearing and Hinge Pin Insertion 42 Initial Patellar Resection 43 Patella Reaming 45 Patella Drilling 46 Trial Reduction and Implantation 47 2 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique APPENDICES ORDERING INFORMATION Appendix 1: The Cemented Tibial Stem Extensions 48 Appendix 2: Step Wedge Preparation 51 Appendix 3: Thick Tray Preparation 54 Implant Listing 55 Compatibility Chart 59 Instruments 60 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 3 KEY SURGICAL STEPS SUMMARY Incision and Exposure Tibial Medullary Canal Preparation Femoral Medullary Canal Preparation Distal Femoral Resection Final Trialing Patella Preparation 4 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique Tibial Resection Tibial Trial Assembly Femoral Preparation A/P and Chamfer Cuts Femoral Box Cuts Implantation Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 5 S-ROM® NOILES™ ROTATING HINGE KNEE SYSTEM The S-ROM NOILES Rotating Hinge features: ·· S-ROM Femoral Components available in three sizes ·· 7 degree physiological valgus, fixed in the femoral component ·· Deep femoral trochlear groove ·· M odular porous sleeves to accommodate bone defects of the Engh Type II and Type III classification and allow possible bone ingrowth ·· A vailable with both cemented and press-fit slotted stems for both femur and tibia ·· B road, congruent contact areas between femoral and tibial components to best distribute surface and sub-surface stresses in the polyethylene ·· A rotating hinge that accommodates axial rotation, reducing stresses at the bone cement/implant interfaces 6 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique THE S-ROM HINGE SYSTEM OVERVIEW The MBT Revision Knee System is comprised of the following components: The S-ROM Hinge Knee System is comprised of the following components: ·· T ibial Components are available in eight sizes, 1, 1.5, 2, 2.5, 3, 4, 5 and 6 ·· H inged Femoral Component is available in three sizes, X-Small, Small and Medium ·· Tibial Metaphyseal Sleeves are available in 29 mm (cemented or porous), 37 mm, 45 mm, 53 mm and 61 mm sizes (M/L dimension) ·· F emoral Metaphyseal Sleeves are available in 20 mm (cemented only), 31 mm, 34 mm, 40 mm and 46 mm sizes (M/L dimension), and can be used with or without a stem ·· T ibial Wedge Augmentation Components: Step Wedge in 5, 10 and 15 mm thicknesses ·· 7 5, 115 and 150 mm Fluted Universal Stem lengths in 10 to 24 mm diameters in 2 mm increments ·· 3 0 and 60 mm Cemented Universal Stem lengths in 13 mm diameters. 90, 120, 150 Cemented Tapered Universal stem lengths in 13 mm diameters ·· T hick Trays are available in three different sizes (2, 3 and 4) and two different thicknesses (+15 mm and +25 mm) ·· A ccepts Rotating Platform hinged insert from the LPS™ (Limb Preservation System), which is compatible with the S-ROM NOILES Rotating Hinge (NRH) Femoral Component and LPS Femoral Component ·· 5 and 10 mm Distal Femoral Augments ·· 7 5 mm, 115 mm and 150 mm Fluted Universal Stem lengths in 10 mm to 24 mm diameters in 2 mm increments ·· 3 0 mm and 60 mm Cemented Universal Stem Lengths in 13 mm and 15 mm diameters ·· 9 0 mm, 120 mm, and 150 mm Tapered Cemented Universal Stem lengths in a 13 mm diameter ·· 9 0 mm Tapered Cemented Universal Stem length in a 15 mm diameter (Must be used with a sleeve) Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 7 INCISION AND EXPOSURE Initial Incision When possible, follow the scar from the primary procedure (Figure 1). Where parallel incisions are present, the more lateral is usually preferred, as the blood supply to the extensor surface is medially dominant. Where a transverse patellectomy scar is present, the incision should transect it at 90 degrees. Where there are multiple incision scars or substantial cutaneous damage (burn cases, skin grafting, etc.), one may wish to consult a plastic surgeon prior to surgery to design the incision, determine the efficacy of pre-operative soft tissue expansion and plan for appropriate soft tissue coverage at closure. Figure 1 Capsular Incision The fascial incision extends from the rectus femoris proximal margin to the distal margin of the tibial tubercle following the patella’s medial border, maintaining a 3-4 mm cuff for reapproximation of the vastus medialis aponeurosis at closure (Figure 2). Where mobilization of the extensor mechanism and patella is problematic, extend the skin and capsular incisions proximally. Figure 2 8 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique INCISION AND EXPOSURE Occasionally an early retinacular release is indicated to assist with patellar eversion. Where eversion difficulties persist, a quadriceps snip, a proximal inverted quadriceps incision (modified V-Y) or a tibial-tubercle osteotomy may be indicated. Perform appropriate ligamentous release based upon pre-operative and intra-operative evaluation. Release fibrous adhesions to re-establish the suprapatellar pouch and medial and lateral gutters (Figure 3). In many revision cases, the posterior cruciate ligament will be absent or non-functional; when this is the situation, excise any residual portion. Exercise care when everting the patella. Frequently, subluxing the patella laterally is adequate. Doing so will help avoid patella tendon avulsion. Figure 3 Implant Extraction from the Primary Procedure Take care to preserve as much bone as possible. To this end, assemble a selection of tools, including thin Osteotomes, an Oscillating Saw, a Gigli Saw, a highspeed Burr and various extraction devices, but many cases will require only the thin Osteotome. Carefully disrupt the bone/cement or bone prosthesis interface before attempting extraction (Figure 4). Disengage the implanted components and extract as gently as possible, in such manner as to avoid fracture and unnecessary sacrifice of bone stock. Where the entire prosthesis is to be replaced, it is advantageous to remove the femoral component first, as this will enhance access to the proximal tibia. Clear all residual methyl methacrylate with hand (chisels) or power tools. Figure 4 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 9 INTRA-OPERATIVE EVALUATION The surgeon should establish two anatomic conditions to facilitate revision arthroplasty: the level of the joint line and the disparity in the flexion and extension gaps (Figure 5). Joint Line Evaluation In an average knee in full extension, the true joint line can be approximated in reference to several landmarks. ·· It lies 12–16 mm distal to the femoral PCL attachment ·· It lies approximately 3 cm distal to the medial epicondyle and 2.5 cm distal to the lateral epicondyle ·· It lies distal to the inferior pole of the patella (approximately one finger width) ·· Level with the old meniscal scar, if available Additional pre-operative joint line assessment tools include: 1) Review of original pre-operative roentgenogram of the Total Knee Arthroplasty (TKA) 2) Review of roentgenogram of contralateral knee if non-implanted Figure 5 11 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique INITIAL PREPARATION OF THE TIBIA The Tibial Alignment System When pre-operative evaluation and X-rays indicate that Fluted Stem Extensions, Metaphyseal Sleeves or Wedges are required, it is recommended that the proximal tibia be prepared with reference to the position of the I.M. Rod. Note: Where a Cemented Stem Extension is indicated, see Appendix 1 (page 48). 4 cm Place the knee in maximal flexion with the patella laterally retracted and the tibia distracted anteriorly and stabilized. Release fibrosis around the tibial border or excise as required to ensure complete visualization of its periphery. Approximate the location of the medullary canal with reference to pre-operative anterior/posterior (A/P) and lateral X-rays and to the medial third of the tibial tubercle. 2 cm Introduce a 9 mm drill into the canal to a depth of 2–4 cm. Avoid cortical contact (Figure 6). Figure 6 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 11 INITIAL PREPARATION OF THE TIBIA Reaming the Medullary Canal Assemble the Straight Reamer to the T-Handle. If power reaming, it will be necessary to attach the modified Hudson Adapter to the Straight Reamer. The shaft of the reamer contains markings in 25.4 mm (1 in) increments. Each marking is numbered to use as a reference when reaming to the appropriate depth. Fluted stem lengths are available in 75, 115 and 150 mm. Determine the length and diameter of the prosthetic Stem Extension with Templates (Cat. No. 2178-30-100) applied to preoperative X-rays. Use the Reamer Depth Chart (Figure 7) to determine the appropriate mark on the reamer for canal reaming depth. Another option to determine reamer depth is to measure the trial assembly against the reamer and note the corresponding depth mark for reaming. Sequentially open the canal with progressively larger reamers until firm endosteal engagement is established (Figure 8). MBT Revision Tray Press-Fit Stems 75 mm 2 115 mm 3 150 mm 4 30 mm 1 60 mm 2 90 mm 2.5 120 mm 3.5 150 mm 4 Cemented Stems Note: Simple cortical contact should not be construed as engagement. The fixed relationship of the reamer to the cortices ensures the secure fit of the appropriate reamer and, subsequently, the corresponding fluted stem. It is equally important to not over-ream osteopenic bone. While reaming the proximal tibia, pay close attention to the reamer to assure that it is somewhat centrally located to the exposed proximal tibial surface. Eccentric reaming can occur, which could lead to undersizing of the tibial component. Reamer Line Depth Figure 7 T-Handle Straight Reamer The size of the final reamer indicates the diameter of the implant stem. The fluted stems are available in even sizes (10 through 24 mm). Perform final reaming with an even-sized reamer. The final implant will have a .4 mm press-fit versus the reamer and a .5 mm press- fit versus the Stem Trials. Note: Refer to Appendix 1 (page 48) for cemented stem preparation. Figure 8 11 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique PREPARATION OF THE METAPHYSEAL BONE – TAPERED REAMER For Diaphyseal Engaging Stem and Metaphyseal Filling Sleeve Attach the appropriately sized Stem Trial to the end of the MBT Revision Tapered Reamer. Note: Assembly of the Stem Trial may be aided by the pre-attachment of the T-Handle to the MBT Revision Tapered Reamer. Taper ream to the planned proximal tibial resection level (Figure 9). When finished reaming, the notches on the Drill should line up with the planned proximal tibial resection level. Note: Use the “cemented” Tapered Reamer when requiring a cement mantle or when utilizing a sleeve. Use the Press-Fit Tapered Reamer when line-to-line fit is desired and a sleeve will not be utilized (Figure 10). Use End-Cutting Primary Reamer (Cat. No. 2178-63-199) when a stem or sleeve will not be used. Tibial Resection Plane Notches on the Drill Note: To avoid Stem Trial disengagement, do not reverse ream. At this point, intra-operatively determine if a Metaphyseal Sleeve will be used. Note: Metaphyseal Sleeves are ideal to provide filling of Engh Type II or III defects in revision TKA. The steps of the Metaphyseal Sleeve also provide progressive loading of the bone with porous coating, which enhances fixation. If a Metaphyseal Sleeve is selected, see page 16 in order to broach the metaphyseal bone. If a Metaphyseal Sleeve will not be used, see the following page to prepare for the proximal tibial resection. Figure 9 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 11 PROXIMAL TIBIAL RESECTION – TAPERED REAMER Attach the 2 degree Tibial Cutting Block to the I.M. Tibial Referencing Device. Attach the I.M. Tibial Referencing Device to the shaft of the Tapered Reamer. Position the I.M. Tibial Referencing Device with the preattached 2 degree Cutting Block onto the shaft and allow it to descend to the proximal tibial surface. Since considerable bone stock may have been sacrificed in the primary TKA, minimize the amount resected: no more than 1-2 mm from the most prominent condyle, managing residual defects of the contralateral condyle with either prosthetic augment or bone graft. Resection is based on tibial deficiency and the level of the joint line. Compensate deficiencies with sleeves, wedges and/or bone grafts. Advance the cutting block to the anterior tibial cortex and lock into position by tightening the knurled knob on the outrigger. Preliminary rotational alignment is based on the medial third of the tibial tubercle. Secure the alignment device to the reamer shaft with the lateral Setscrew (Figure 10). Pin the Tibial Cutting Block so a minimal resection is made from the proximal tibia. Utilize the Stylus when necessary (Figure 10). Pins Note: There is a slotted and non-slotted end to the Stylus. The difference between the two is 5 mm. Note: If a Metaphyseal Sleeve is to be used the tibial resection will be performed using the Tibial Sleeve Broach (see page 16, Figure 12). 11 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique Figure 10 PROXIMAL TIBIAL RESECTION – TAPERED REAMER Remove the I.M. device while leaving the degree Cutting Block in place. Remove the Tapered Reamer and resect the proximal tibia (Figure 11). Note: At this point determine whether a step wedge is necessary on either the medial or lateral side to augment a defect, or both sides in order to restore the joint line. If a wedge is necessary on one side, it is recommended that the step wedge be prepared after rotational position of both the femoral and tibial components have been determined. For step wedge preparation see Appendix 2 (page 51). Figure 11 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 11 PREPARATION OF THE METAPHYSEAL BONE – BROACH Optional For Sleeve Utilization Only Note: The MBT Revision Tibial Tray will accept either a tibial Metaphyseal Sleeve or a tibial Step Wedge. Only the 29 mm Sleeve is indicated for use with a Tibial Step Wedge. Attach the MBT Revision Broach Handle to the smallest broach and then attach the appropriately sized Stem Trial. The broaches are asymmetrical, position the “ANT” engraving on the broach anteriorly. Impact the broach into the tibia until the top surface of the broach is at the desired proximal tibial resection level. When broaching the proximal metaphysis, take care to assure the appropriate rotation of the Broach. Note: The corresponding tibial sleeve implant allows up to +/- 20 degrees of rotation from the centerline of the MBT Revision Tray. Check for rotational stability of the broach. If the broach (not the handle) moves in the canal, it is not rotationally stable. Tibial Resection Plane If the broach is unstable or the defect is unfilled, repeat with consecutively larger broaches until the desired fit is achieved (Figure 12). Remove the Broach Handle, leaving the last broach in place. Any defects remaining can be filled with allograft or autologous bone placed in intimate contact with the sleeve. Two common tibial broaching techniques: 1) Chase the defect by rotating the broach to fill the defect until reaching rotational stability of the broach. If utilizing this technique the surgeon must be aware that the sleeves are allowed to rotate +/-20 degrees with respect to the MBT Revision Tibial Tray. 2) Align the broach with the medial third of the tibial tubercle and progressively broach until rotational stability of the broach is attained. Figure 12 11 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique PREPARATION OF THE METAPHYSEAL BONE – BROACH Resect the proximal tibia utilizing the top of the broach as a guide (Figure 13). The top of the broach has a 2 degree slope built in. The proximal cut should be parallel to the top of the broach. Note: If a cutting guide is desired for resecting the proximal tibia with the tibial broach in place, assemble the SP2 0 degree Tibial Cutting Block (Cat. No. 96-6320) to the SP2 IM Tibial Guide and slide over the Broach Adapter Outrigger (Cat. No. 2178-01-108). Slide this assembly onto the boss of the seated tibial broach, pin the block, remove the outrigger, and resect through the slot of the cutting block (Figure 14). Figure 13 Slide the tibial view plate which best covers the proximal tibial over the broach post. Note the view plate size as it will dictate the size of the MBT Revision Tibial Base Trial that will be used. The tibial view plate is transparent to help visualize tibial coverage (Figure 15). The template matches the implant to aid in orienting the tibial sleeve to the tibial base during assembly. Figure 14 Figure 15 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 11 TIBIAL TRIAL ASSEMBLY Assemble the tibial tray trial with the stem extension and sleeve trial, if applicable (Figure 16). Position the Tibial Trial construct into the prepared tibial canal (Figure 17). Assess proximal tibial coverage and rotation of tibial component. The base plate should be positioned to provide the best coverage of the tibial condylar surface. Note: The MBT Revision Tibial Keel Punch with the Universal Handle may be utilized to assist with seating of tibial trial construct. Once the tibial trial construct is seated the Keel Punch must be removed in order to accommodate the use of Spacer Blocks. Leave the trial in place and proceed to femoral preparation, final tibial preparation will occur after femoral preparation is complete. Note: A 14 mm or smaller size stem implant can be pulled through the sleeve implant. If the stem is 16 mm or greater it will not pull through the sleeve. Figure 16 Figure 17 11 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique PREPARATION OF FEMORAL DIAPHYSIS Intramedullary Femoral Alignment System This technique is designed to flow in a logical sequence, from reaming the diaphysis, to broaching the metaphysis and cutting the bone. The length and diameter of the stem extension is determined with templates applied to pre-operative roentgenograms. Begin the procedure with the preparation of the medullary canal (Figures 18 and 19). Enter the medullary canal with a 9 mm drill to a depth of 3-5 cm (Figure 20). Take care that the drill avoids the cortices. It is helpful to palpate the distal femoral shaft as the drill is advanced. Figure 18 Where impedance of the intramedullary canal is anticipated, adjust the entry point accordingly. Figure 19 Figure 20 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 11 REAMING THE MEDULLARY CANAL Connect the Reamer Handle to a small diameter MBT Revision Reamer. If power reaming, it will be necessary to attach the modified Hudson Adapter to the Straight Reamer. Note: The reamer shaft contains markings in 25.4 mm increments to accommodate the various Universal Stem/Sleeve length combinations (Figure 21). Use the Reamer Depth Chart to determine reamer depth for each combination of components (Figure 22). Another option to determine reamer depth is to measure the trial assembly against the reamer and note the corresponding depth mark for reaming. You may also determine the length and diameter of the prosthetic stem extension with templates (Cat. No. 2294-99-035: SIGMA Femoral Adapter Sleeve and Stem Template) applied to pre-operative X-ray. The S-ROM femoral components can be found on the S-ROM Templates (XRT-115). The S-ROM Femoral Component accepts the following stems, only with the use of a femoral sleeve: ·· Universal Fluted Stems of 75, 115 and 150 mm in diameters of 10-24 mm in 2 mm increments ·· C emented Stems available in lengths of 30 and 60 mm lengths and a diameter 13 mm or 15 mm Example: Ream to the tick mark #4 when using S-ROM femur with 31 mm Sleeve and 75 mm PressFit Stem ·· C emented Tapered Stems available in lengths of 90 mm (13 mm and 15 mm diameter) and 120 mm and 150 mm (13 mm diameter only) Note: The Stem is the same as is currently used with the MBT Revision Trays. Figure 21 22 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique REAMING THE MEDULLARY CANAL In 1 mm diameter increments, sequentially open the medullary canal with MBT Revision Reamers of progressively greater size until firm endosteal engagement is established. S-ROM Femur Take care to ream the canal in line with the femoral axis to avoid putting the implant in flexion. Note: Do not reverse ream. It is important that simple cortical contact of the tip not be construed as engagement. Cemented Stem Use Where a cemented stem extension is indicated, perform final reaming with a 15 mm diameter reamer for the 13 mm diameter stem extension; similarly a 17 mm diameter reamer is used to accommodate the 15 mm diameter stem extension. This allows for creation of a cement mantle. Cemented Stems Press-Fit Stems 20 mm 31 mm 34 mm 40 mm 46 mm 30 mm 2 2 60 mm 3 3 90 mm 4 4 120 mm 5 6 150 mm 6 7 75 mm 4 4 115 mm 5 5 150 mm 6 7 Figure 22 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 22 PREPARATION OF THE METAPHYSIS – SLEEVE USE After reaming the intramedullary canal, attach the Threaded Shaft to the Broach Reamer and then to the appropriate Stem Trial as determined by straight reaming (Figure 23). Ream to the 20 mm, 31 mm, 34 mm etch mark on the Threaded Shaft (Figure 24). Broach Reamer Figure 23 22 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique Figure 24 PREPARATION OF THE METAPHYSIS – SLEEVE USE When using the Broach Reamer, the next smaller diameter Stem Trial may be used to allow for easier reaming. The Broach Reamer will be necessary when utilizing a 20 mm sleeve and for the beginning of larger sequential broaching when using a 31 mm or larger sleeve. After broach reaming has been completed, attach the 31 mm broach to the Broach Handle (Figure 25). Attach the appropriate Stem Trial to the broach as determined by straight reaming. Give close attention to the medial orientation of the broach. Note: The broach is asymmetrical; and the narrow side of the broach must point medially (Figure 26). Note: When prepping for a 20 mm sleeve, leave the Broach Reamer and threaded shaft in the canal and perform the subsequent femoral cuts off the reamer. Lateral Side Medial Side Figure 26 Figure 25 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 22 PREPARATION OF THE METAPHYSIS – SLEEVE USE Sequentially broach to the desired dimension of 31, 34, 40 or 46 mm (Figure 27). When the LCS®/SROM etch mark on the Broach Handle is at the planned distal resection level, check the broach’s rotational stability. If the broach (not the handle) moves in the canal, it is not rotationally stable. If the stability of the broach is unsatisfactory, move up to the next broach size. The last broach used will be the femoral sleeve size. The broach depth sets the extension gap/joint line. In patients with a large degree of distal femoral bow, closely monitor the anterior progression of the broach during impaction. Excessive anterior placement of the broach may result in a loose flexion gap. Planned Level of Distal Resection 22 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique Figure 27 PREPARATION OF THE METAPHYSIS – SLEEVE USE After broaching is complete, remove the Broach Handle from the broach. With the broach seated in the femur, attach the Threaded Shaft to the broach (Figure 28). Distal, anterior, chamfer, and notch cuts will reference off the Threaded Shaft/Broach assembly. Figure 28 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 22 FEMORAL PREPARATION – DISTAL RESECTION Distal Resection Set the valgus angle to 7 degrees and Left/Right on the Distal Femoral Alignment Guide by compressing the two triggers and lock in place by rotating the blue locking lever clockwise. Place the Femoral Alignment Guide on the Threaded Shaft and seat against the distal femur (Figure 29). Rotate the knob on the Femoral Resection Guide counterclockwise until the arrow is pointing to the padlock symbol. Slide the Distal Femoral Connector into the Femoral Resection Guide. Rotate the knob on the Femoral Resection Guide clockwise. Every click moves the Revision Distal Cutting Block 1 mm proximal or distal. Turn the knob clockwise from 15 all the way down to 0 (which is the padlock symbol). This will set the block up for a 0 mm resection (Figure 30). Figure 29 Distal Femoral Connector Distal Femoral Resection Guide Slide the revision Distal Cutting Block onto the Distal Femoral Block attachment. The tang on the block connector will slide into the 0 mm cutting slot on the cutting block. The trigger should engage in the hole behind the 0 mm slot (Figure 31). Figure 30 Note: An open resection will resect 4 mm less femur. When a 0 mm open resection is desired, the dial should be set to 4 mm. Revision Distal Cutting Block Position the resection guide over the two legs of the Distal Femoral Alignment Guide until the Distal Cutting Block touches the anterior femur (Figure 32). Note: The Revision Distal Block is equipped with 0, 4, and 8 mm saw slots. Please keep in mind that if the resection level is not at 0 (the padlock symbol) this will alter the resection. If the resection knob is set at 2, for instance, the saw slots will perform 2, 6, and 10 mm resections. Figure 31 Figure 32 22 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique FEMORAL PREPARATION – DISTAL RESECTION Rest the Femoral Alignment Guide against the most prominent distal condyle. If no distal augments are needed, proceed with pinning the distal resection block and making the distal cuts through the 0 mm resection slot (Figures 33 and 34). If it is determined that a 5 mm or a 10 mm Distal Augment will be needed on only one condyle, perform a 0 mm clean-up cut first on the prominent condyle. Then turn the dial on the Femoral Resection Guide to 5 mm or 10 mm and make the cut on the other condyle through the 0 mm resection slot. Note: Do not use the saw slots on the Distal Block to make augment cuts. The augment slots on this block are set up in 4 mm increments instead of the needed 5 mm increments for S-ROM. Figure 33 Alternatively, the LCS Revision Distal Femoral Resection Guide may be used instead of the SIGMA Revision Distal Femoral Resection Guide. The LCS Revision Block (Cat. No. 2178-60-070) is already set up to accommodate augments in increments of 5 mm. Note: When adding 5 or 10 mm Distal Augments to both sides of the femur, it may be necessary to re-evaluate the depth the sleeve was broached to, based upon the addition of augments. If the augments require the broach to be distalized, rebroaching should occur with a larger broach in order to distalize the sleeve in the canal without losing press-fit. Figure 34 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 22 FEMORAL PREPARATION – DISTAL RESECTION Once the pins are in place, unlock the Distal Cutting Block from the Distal Femoral Connector, using your thumb and index finger to release the attachment. Slide the Femoral Resection Guide upwards on the Alignment Guide legs until the block connector disengages from the Cutting Block and in one motion remove the Femoral Alignment Guide by pulling the instruments distally over the Threaded Shaft (Figure 35). In many cases, little, if any, bone is removed from the distal femur as the joint line is effectively elevated with the removal of the primary femoral component. As the level of resection is based on the preservation of bone stock, each condyle is cut only to the level required to establish a viable surface, with augmentation employed to correct imbalance. Release attachment 1. Slide femoral resection guide upwards 2. Remove femoral alignment guide towards the T-Handle The resection is then performed through the slot appropriate for each condyle, using a standard 1.19 mm thick blade (Figure 36). Figure 35 Note: If a ½in. wide Standard Saw Blade is used it can complete both medial and lateral distal femoral cuts with the entire jig still in place. An example of a medial resection at 0 mm Figure 36 22 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique FEMORAL A/P AND CHAMFER CUTS The Femoral Cutting Guide is size specific (two blocks – X-Small/Small and Medium). Determine the femoral component size by pre-operative templating and comparing the Femoral Component Trial to the size of the femur. Use the size which gives the best medial/ lateral (M/L) coverage. S lide the appropriately sized cutting guide over the Threaded Shaft. Use the corresponding hole for a left or a right knee (Figure 37). Place the guide into neutral rotation by aligning the anterior cortex parallel with the anterior portion of the guide. The SIGMA Angel Wing (part number: 96-6530) may be helpful in this step. Also use the femoral epicondylar axis as the rotational reference. Note: If distal augmentation will be used, use 5 or 10 mm Box Cut Guide Spacers on the appropriate condyle(s). Establish the proper rotation of the A/P block first, then pin through one each of the medial and lateral pin holes. Remove the block from the pins, then put the appropriate spacer(s) over the pins before replacing the A/P block. These spacers should rest between the cutting guide and the distal condyle(s) to fill these gaps appropriately (part numbers: 5 mm - 63-3305A and 10 mm - 63-3306A). Pin Pin Box Cut Guide Spacer (5 mm) Achieve fixation of the cutting guide with 1/8 in. drill pins, introduced through the convergent holes on the side of the block. These Pins will need to be temporarily removed later to move to the notch guide (Figure 38). Attach the Removable Handles to the cutting guide (optional). Figure 37 Figure 38 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 22 FEMORAL A/P AND CHAMFER CUTS Make the anterior cut (Figure 39) first. Proceed to make the anterior chamfer cut through the captured slot. If the block was previously pinned, temporarily remove one pin at a time while making the resection. Make the posterior chamfer cut (Figure 40) by holding the saw blade flush with the cutting guide. If anterior pins are being used for fixation, remove the pin while resecting, then replace. Care should be taken to avoid damaging posterior soft tissue. If not previously pinned, place at least one 1/8 in drill pin on each side of the guide. These will be used to position the Box Cut Guide. Next, remove the convergent pins. Anterior Chamfer Cut Figure 39 Finally, remove the femoral cutting guide, leaving the 1/8 in. drill pins in place (Figure 41). Note: It may be easier to remove the threaded shaft first, before trying to slide the blocks off the pins. Figure 40 Remove Pins Figure 41 33 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique FEMORAL BOX CUTS Use 5 or 10 mm Box Cut Guide Spacers if distal Augmentation Blocks will be used (Figure 42). Slide the Hinge Femoral Box Cut Guide over the 1⁄8 in. drill pins placed in the previous step or align with the lines marked off the Femoral Cutting Guide. If Distal Augmentation Blocks will be used, slide 5 or 10 mm Box Cut Guide Spacers over the drill pins before positioning the Box Cut Guide. Four additional 1⁄8 in. drill holes are provided on the anterior surface of the Box Cut Guide; 1⁄8 in. drill pins are recommended for additional stability. Box Cut Guide Box Cut Guide Spacer Figure 42 Holding the saw blade flat against the inner surface of the Box Cut Guide, make the side cuts for the center box (Figure 43). se a narrow saw blade (12.7 mm or 0.5 in), placed on U the sloped guide surface, to remove the bone block of the center box (Figure 44). Hinge Box Cut Guide Saw Blade Figure 43 Narrow Saw Blade (1⁄2 in. wide) 1/8 in. Drill Pin Figure 44 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 33 FINAL PREPARATION OF THE TIBIA Assess proximal tibial coverage and rotation of tibial component. Impact the appropriate Keel Punch (utilize the cemented Keel Punch if a cement mantle is desired or the Press-Fit Keel Punch if line-to-line contact is desired) (Figure 45). The base plate should be positioned to provide the best coverage of the tibial condylar surface. Figure 45 33 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique FEMORAL TRIAL INSERTION Two femoral Augmentation Blocks are available for the S-ROM Noiles Rotating Hinge Total Knee System. They are 5 and 10 mm Distal Blocks. One size fits all, i.e. X-Small, Small and Medium hinge femoral components. If distal augmentation is required, attach the Augmentation Block Trial(s) with bone wax to the Femoral Component Trial (Figure 46). Femoral Augment Block Figure 46 Implant Cat. No. Femoral Location Use with S-ROM Noiles Rotating Hinge Femoral Size Augment Thickness Trial Cat. No. 623805 Distal All Sizes 5 mm 633785 623810 Distal All Sizes 10 mm 633790 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 33 FEMORAL TRIAL INSERTION Connect the Stem Trial into the appropriate Femoral Sleeve Trial. The diameter of the Stem Trial will be the same as the final Straight Reamer used; the size of the Femoral Sleeve Trial will be the same as the final Femoral Broach used (Figure 47). Slide the Sleeve/Stem Trial assembly into the prepared cavity in the femoral canal to allow the assembly to self align with the broached surfaces (Figure 48). Stem Trial Note: The narrow side of the Sleeve Trial points medially. Femoral Sleeve Trial Femoral Component Trial Figure 47 Trial Assembly inserted into Femoral Cavity Figure 48 33 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique FEMORAL TRIAL INSERTION Slide the Femoral Component Trial onto the resected femur, aligning the anterior cut with the posterior aspect of the patellar flange. After the Femoral Component Trial engages the Femoral Sleeve Trial, impact using the Femoral Driver on the Universal Handle. Check accuracy of the bone cuts. Revise or rebroach if necessary (Figure 49). Universal Handle Femoral Driver Note: If Distal Augmentation Blocks will be used, fix Distal Augment Block Trials to the Femoral Trial with bone wax before impacting the Trial onto the femur. Femoral Component Trial Femoral Sleeve Trial Push down on the button on the quick release handle and connect the femoral driver Two ends engage Figure 49 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 33 TRIAL REDUCTION Slide the condyles of the Femoral Trial into the Plateau Trial. If the insert trial lifts off the tibial baseplate during flexion, check the posterior area for soft tissue, osteophyte or bone impingement (Figure 50). It is easier to insert the Hinge Pin Trial prior to placing the insert trial into the tibial baseplate. The Hinge Pin Trial can be inserted either medially or laterally (Figure 50). With the leg in full extension, evaluate the mechanical axis. The center of the femoral head, knee and talus should all be in line (Figure 51). Without hinge pin,“lift off” during flexion indicates posterior impingement The knee should be stable throughout the full range of motion (Figure 52). Check ligament tension and leg length. Revision of the tibial or femoral resection may be required if satisfactory stability cannot be achieved. Accommodate additional bone resection with rebroaching. Figure 50 Remove the femoral trials and ensure that the rotational alignment of the assembly is preserved.This is used as a reference when assembling the modular implant. Note: In patients with severe soft tissue loss, flexion of the knee beyond 90 degrees may cause distraction and subluxation of the tibial plateau out of the modular tibial base. In this instance, fit the patient with a post-operative brace, limiting flexion to 90 degrees and no more for at least three months. This helps soft tissue establishment of flexion tension. Consult package insert. Hinge Pin Trial Figure 52 Figure 51 33 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique IMPLANT ASSEMBLY – TIBIA Tibial Sleeve Assembly Note: It is imperative to assemble the Sleeve prior to stem attachment. Note: Sleeves and Step Wedges can only be used together if using a 29 mm Sleeve. Remove trial component in one piece (use as guide for assembly of implants). Place the MBT Revision Tray on a firm, stable, padded surface. Set the Tibial Sleeve in an orientation that matches the prepared canal. Matching the orientation of the Tray/Sleeve Trial is helpful in determining appropriate rotation of the final tibial tray/sleeve implant (Figure 53). The sleeve can rotate 20 degrees internally or externally. Using the Sleeve Impactor and a Mallet, impact the sleeve onto the MBT Revision Tray. Deliver several strikes to engage the two components (Figure 54). Stem Component Assembly Attach the Stem Extension to the prosthetic tray using the two appropriate Wrenches to ensure full engagement (Figure 55). Figure 53 Figure 54 Figure 55 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 33 TIBIAL IMPLANTATION Implanting the Tibial Component Thoroughly cleanse the site with pulsatile lavage. Perforate with small drill holes on the prepared tibial surface to facilitate penetration of methyl methacrylate (Figure 56). Pack residual small cavitory bone defects with cancellous autograft, if available, or allograft. Apply methyl methacrylate cement to the proximal tibial surface (Figure 57) or directly to the underside of the tibial tray component. When a Fluted Stem or a Fluted Stem with a Metaphyseal Sleeve is used, ensure the medullary canal remains free of cement. Clear all extruded cement with a Curette. Seat the Tibial Implant construct into the prepared tibia by impacting the RP Tray Impactor and Universal Handle assembly (Figure 58). Figure 56 Figure 57 Figure 58 33 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique IMPLANT ASSEMBLY – SLEEVE AND STEM USE Implant Assembly - Sleeve and Stem Use Implant assembly order (with Sleeve and Stem use): Apply cement to this side of the distal augmentation block ·· Add distal augments if necessary ·· Attach stem to sleeve ·· Attach sleeve construct to femoral construct Implantation After assembling the femoral components, prepare one package of bone cement according to instructions. Apply cement to the augmentation block(s) on the side which contacts the femoral component, and to the corresponding surface(s) of the femoral component (Figure 59). Attach the augmentation block(s) to the femoral component. Use an Augment Block Clamp to secure to the femoral component until the cement is fully cured. Note: When distal augmentation blocks are used with the S-ROM Noiles Rotating Hinge femoral component, place the Augment Block Clamp into the distal condylar “pocket” of the femoral component (Figure 60). Figure 59 S-ROM Noiles Rotating Hinge Femoral Component The remainder of the mixed cement may be used to implant the patella and tibial component while the blocks are setting. Distal Augment Apply cement only to this side of the distal augmentation block Figure 60 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 33 IMPLANT ASSEMBLY – SLEEVE AND STEM USE To attach the Universal Stem to the Universal Femoral Sleeve, thread the stem onto the sleeve. Grasp the sleeve with the Tibial Sleeve Clamp and use the Stem Extension Wrench to grasp Universal Stem and tighten (Figure 61). Apply sufficient force to both Wrenches to ensure that the Stem is secure. Place the femoral component with the Femoral Adapter on a firm, stable surface. Place the appropriate sleeve and stem construct on top of the Femoral Adapter assembly (Figure 62). Use the sleeve and femoral construct trial to help set the final sleeve and femur implant rotation. Figure 61 Figure 62 44 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique IMPLANT ASSEMBLY – SLEEVE AND STEM USE Slide the Femoral Stem/Sleeve Impactor on top of the stem and forcefully apply three strikes with a Mallet to engage the two component assemblies (Figure 63). Note: The Femoral Stem/Sleeve Impactor has two uses, one end for use of a sleeve without a stem extension and one end for a sleeve and stem combination. The definitive components are implanted in the following order: ·· T ibial tray (with stem, sleeve or wedges) ·· F emoral component (with stem, sleeve and augments) ·· LPS Hinged insert Implant the femoral component using the Femoral Impactor (Figure 64). Figure 63 Universal Handle Figure 64 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 44 BEARING AND HINGE PIN INSERTION After the femoral component and tibial tray have been cemented into place, do one final check with the trial inserts. Once the proper thickness has been verified, introduce the actual implant into the sterile field. Note: Take extreme care when opening the LPS Universal Insert to hold onto the bushings to ensure they do not fall out. Hinge Pin Put the condyles of the femoral component into the corresponding recesses in the tibial plateau. Insert the Hinge Pin through the hole on the medial or lateral side of the femoral component. Orient the rectangular head of the Hinge Pin with the rectangular recess in the femoral component (Figure 65). "Clothespin" Squeeze the “clothespin” of the Hinge Pin together and insert the Hinge Pin into the femoral component. Make sure the Hinge Pin is securely locked in place (Figure 66). Place the LPS Universal Insert post into the cone of the MBT Revision Implant (Figure 67). Figure 65 Needle Holder or Clamp Test the knee through full range of motion (Figure 68). Figure 66 Figure 67 44 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique Figure 68 INITIAL PATELLAR RESECTION Measure and record the overall thickness of the patella using a Caliper (Figure 69). Resect approximately 7 mm of bone from the posterior patella surface using an Oscillating Saw. Measure and record the thickness of the resected/ removed bone in order to properly duplicate the original thickness. Caliper Figure 69 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 44 INITIAL PATELLAR RESECTION Patella Domes are available in four diameters (Figure 70). Select a patella trial with the diameter that best matches the patient’s patella (Figure 70). 38 mm Select the Patella Reamer Depth Adjuster that is the same diameter as the patella trial. Insert the Patella Reamer Depth Adjuster into the Patella Restraining Instrument. Rotate the depth adjuster 120 degrees clockwise to lock into position (Figure 71). 35 mm 32 mm 30 mm Figure 70 Patella Restraining Instrument Patella Reamer Depth Adjuster Figure 71 44 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique PATELLA REAMING Clamp the Patella Restraining Instrument assembly onto the patella. Lock into position by turning the Thumb Nut clockwise (Figure 72). Insert the Patella Reamer Bushing into the appropriate set of slots on the Patella Reamer Depth Adjuster. Slots on the depth adjuster are marked 1, 2, 3 and 4, which indicate the reaming depth in millimeters. To determine the correct slot, use the formula shown in (Table 1) as a guide. Measured thickness of bone resected and removed Thickness of selected patella component 9 mm - 7 mm Select Slot number = 2 Table 1 Select the Patella Reamer that matches the diameter of the patella component to be used and insert through the Patella Reamer Bushing into the Patella Reamer Depth Adjuster. Ensure that the Patella Reamer is making full contact with the bone prior to reaming. Ream until the Patella Reamer flange makes contact with the Patella Reamer Bushing. Patella Reamer Flange Turn Thumb Nut clockwise to lock into position Patella Restraining Instrument Patella Reamer Bushing Patella Reamer Depth Adjuster Figure 72 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 44 PATELLA DRILLING Remove the Patella Reamer and insert the Patella Drill Guide into the Patella Reamer Bushing. The Locating “Pin” on the Drill Guide will insert into the hole in the Patella Restraining Instrument (Figure 73). 3⁄16 in. Drill Hole 1⁄8 in. Drill Hole Patella Drill Guide Select the 3⁄16 in. Patella Shoulder Drill and prepare the three patella peg holes by drilling through the three larger holes in the Patella Drill Guide. The depth of the holes drilled is correct for the length of the pegs on the selected Patella Button (Figure 74). Optional: Select the 1⁄8 in. Patella Shoulder Drill and drill through the four smaller holes to enhance the cement fixation to the patellar bone. Loosen the Thumb Nut on the Patella Restraining Instrument and remove the entire assembly from the patella bone. Locating Pin Figure 73 Patella Shoulder Drill Patella Restraining Instrument Thumb Nut Patella Drill Guide Locating Pin Patella Reamer Bushing Patella Reamer Depth Adjuster Figure 74 44 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique TRIAL REDUCTION AND IMPLANTATION Place the appropriate diameter Patella Trial into the prepared patella bone. Measure the overall thickness of the patella construct to ensure that it is the desired thickness, i.e. equal to or 1-2 mm less than the original patella thickness. A “no-thumbs” trial reduction and patella tracking evaluation can now be performed. Note: If the reconstructed patella is too thick, repeat the reaming and drilling steps using the number 2, 3 or 4 slot on the Patella Reamer Depth Adjuster. If a greater thickness must be removed, take additional resection from the patella. The reaming and drilling steps must be repeated. (Take care to make sure the patella bone is not cut too thin. Maintain at least 10 mm of patella bone to prevent drill or peg penetration of the anterior cortex). Figure 75 The appropriately sized Patella Dome may now be cemented into place. A Patella Cement Clamp is provided for this purpose (Figure 75). Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 44 APPENDIX 1: THE CEMENTED TIBIAL STEM EXTENSIONS Cemented Stem Reamer Align the Tibial Tray and secure with two Fixation Pins inserted through the holes designated (Figure 1). Seat the MBT Revision Drill bushing onto the tibia trial. Place in the posterior holes. Place the Cemented Drill Bushing into the MBT Revision Drill Bushing (Figure 2). Use the “cemented” reamer to ream to the predetermined selected depths for tray only or the Tray with a 30 or 60 mm cemented stem. Remove the reamer and “cemented” bushing, leaving the tray trial and MBT Revision Drill Bushing in place (Figure 3). Note: Only a 13 mm diameter cemented stem should be used in conjunction with the MBT Revision Tray to avoid a step off at the stem/tray junction. Figure 1 Cemented Drill Bushing MBT Revision Drill Bushing Figure 2 44 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique Figure 3 APPENDIX 1: THE CEMENTED TIBIAL STEM EXTENSIONS Tapered Reamer Assemble the Revision Reamer Adapter onto the Cemented Tapered Reamer. Next, attach the modified Hudson Adapter to the Tapered Reamer, if power reaming. Modified Hudson Adapter Attach the appropriately sized Cemented Stem Trial (13 x 30 mm or 13 x 60 mm) to the Tapered Reamer, if utilizing a cemented stem extension (Figure 4). Ream until the Revision Reamer Adapter is flush with the MBT Revision Drill Bushing (Figure 5). Note: To avoid Stem Trial disengagement, do not reverse ream. Revision Reamer Adapter Figure 4 Figure 5 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 44 APPENDIX 1: THE CEMENTED TIBIAL STEM EXTENSIONS Tapered Cemented Stems Note: Tapered Cemented Stem sizes 13 x 90/120/150 mm are compatible with MBT Revision Trays. Ream the canal with a reamer two sizes larger than the stem. Ream the medullary canal with a 15 mm reamer to implant a 13 mm Tapered Cemented Stem, which allows for a 1 mm circumferential cement mantle at the proximal end of the stem. The cement mantle will be greater around the distal end of the Cemented Tapered Stem (3 mm per side). This provides the following benefits: ·· T hicker cement mantle distally helps assure that a circumferential mantle is present and reduces the possibility of thin or non-existent cement coverage of the stem distally ·· S tresses are greatest at the tip of the stem. A larger cement mantle is advantageous in dissipating these stresses. Thinner cement mantles are more prone to breakdown when exposed to higher stresses Tibial Keel Preparation Place the knee in full extension and determine appropriate rotation of the Tibial Tray. Mark the appropriate rotation with electrocautery on the anterior tibial cortex at the center and sides of the Alignment Handle. Assemble the appropriate Stem Trial to the MBT Revision Tray Trial and seat in the prepared bone bed. Impact the Cemented Keel Punch (Figure 6). Disconnect the Universal Handle leaving the Keel Punch in place for trial reduction (if appropriate). It is recommended that a Cement Restrictor be placed at the appropriate level prior to cementing the component. Use a Cement Gun to fill the canal with methyl methacrylate. 55 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique Figure 6 APPENDIX 2: STEP WEDGE PREPARATION Step Wedge Augmentation Resection for supplementary tibial augmentation may be based on the established position of the Trial Tray. Remove the Femoral Trial to provide greater access. Confirm rotational alignment of the Tibial Tray Trial. Secure the Tray with two Fixation Pins. Attach the Tray Trial Wedge cutting attachment with the Step Wedge Cutting Guide to the Trial Tray. The Step Wedge Cutting Block allows for a 5, 10 or 15 mm Step Wedge preparation as necessary. Slide the block forward to the anterior proximal tibia and secure in place with two Steinmann Pins through the holes marked with (Figure 1). Unlock the block and slide the assembly out of the block. Disconnect the handle from the Trial Tray (Figure 2). Figure 1 Figure 2 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 55 APPENDIX 2: STEP WEDGE PREPARATION Trim the tibia accordingly with an Oscillating Saw so the cut does not extend beyond the central riser (Figure 3). Remove the Block and Pins. Assemble the Trial Wedge to the appropriate Tibial Tray Trial (Figure 4) and introduce into the prepared site. Perform minimal correction with a Bone File where indicated to ensure maximal contact. Step Wedge Cutting Block Figure 3 Figure 4 55 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique APPENDIX 2: STEP WEDGE PREPARATION Confirm positioning, alignment and security of the tray assembly. If there is old cement or sclerotic bone, remove this first with a saw blade or burr prior to punching. Position the MBT Revision Tibial Keel Punch at the tray and cancellous bone interface and impact into the keel configuration. Leave the punch in place and perform a final trial reduction if necessary (Figure 5). Note: Utilize the “cemented” Keel Punch when a cement mantle is desired. Alternative Step Wedge Preparation This is a “free-hand” resection. Assemble the Wedge Trial and Stem Trial to the Tibial Tray Trial. Position the device slightly proximal to the planned resection level. Make a conservative “free-hand” wedge resection and then check cuts with the Trials (Figure 6). Wedge Implant Assembly Note: To aid wedge implant assembly, attach wedge prior to attaching the stem attachment. Assemble the designated wedge to the tray and secure using the appropriate screw. Carefully tighten with the large T-Handle Torque Driver until an audible "click" is discerned, ensuring a full and permanent interlock (Figure 7). Figure 6 Figure 5 Figure 7 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 55 APPENDIX 3: THICK TRAY PREPARATION After impacting the cement or Press-Fit Keel Punch, remove the Keel Punch. Insert the MBT Thick Tray Trial Adapter (15 or 25 mm) onto the Tibial Tray Trial (Figures 1 and 2). Note: The Tibial Tray Trial must be used with the Thick Tray Adapters as the two pieces equal the appropriate sizing – 15 or 25 mm. Perform the final trial reductions utilizing the same technique as the standard MBT Revision Tray. Implant assembly and implantation is also the same as with the standard MBT Revision Tray. If utilizing a Wedge, refer to the Step Wedge Preparation in Appendix 2. Note: A Tibial Wedge can be used with all Thick Tray sizes, except for size 2. Due to the taper, use size 2 Tibial Wedges with size 4 MBT Revision Thick Trays, and use size 1 Tibial Wedges with size 3 MBT Revision Thick Trays. Sleeves may be used with all Thick Trays. Note: Due to the taper, trial with appropriate tray trial size. For example, a size 4 Thick Tray tapers down to a size 2. Use the size 2 Tray Trial with the size 4 Thick Tray Adapter. The size 3 Thick Tray tapers down to a size 1. And the size 2 Thick Tray tapers down to a size 0. The size 0 Tray Trial can be found in the MBT Thick Tray Instrument Set. Figure 1 Figure 2 55 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique IMPLANT LISTING S-ROM Femoral Components (hinge pin is packaged with the femur) Universal Press-Fit Stems 86-7410 75 mm x 10 mm Universal Fluted Stem 62-3401L Medium Left S-ROM Femur 86-7412 75 mm x 12 mm Universal Fluted Stem 62-3401R Medium Right S-ROM Femur 86-7414 75 mm x 14 mm Universal Fluted Stem 62-3411L Small Left S-ROM Femur 86-7416 75 mm x 16 mm Universal Fluted Stem 62-3411R Small Right S-ROM Femur 86-7418 75 mm x 18 mm Universal Fluted Stem 62-3421L X-Small Left S-ROM Femur 86-7419 75 mm x 20 mm Universal Fluted Stem 62-3421R X-Small Right S-ROM Femur 86-7420 75 mm x 22 mm Universal Fluted Stem 86-7421 75 mm x 24 mm Universal Fluted Stem 86-7424 115 mm x 10 mm Universal Fluted Stem 86-7426 115 mm x 12 mm Universal Fluted Stem 86-7428 115 mm x 14 mm Universal Fluted Stem Universal Femoral Sleeves 86-7430 115 mm x 16 mm Universal Fluted Stem 1294-53-205 86-7432 115 mm x 18 mm Universal Fluted Stem 1294-53-215 31 mm Distally Porous Femoral Sleeve 86-7433 115 mm x 20 mm Universal Fluted Stem 1294-53-216 31 mm Fully Porous Femoral Sleeve 86-7434 115 mm x 22 mm Universal Fluted Stem 1294-53-225 34 mm Distally Porous Femoral Sleeve 86-7435 115 mm x 24 mm Universal Fluted Stem 1294-53-226 34 mm Fully Porous Femoral Sleeve 86-7438 150 mm x 10 mm Universal Fluted Stem 1294-53-235 40 mm Distally Porous Femoral Sleeve 86-7440 150 mm x 12 mm Universal Fluted Stem 1294-53-236 40 mm Fully Porous Femoral Sleeve 86-7442 150 mm x 14 mm Universal Fluted Stem 1294-53-245 46 mm Distally Porous Femoral Sleeve 86-7444 150 mm x 16 mm Universal Fluted Stem 1294-53-246 86-7446 150 mm x 18 mm Universal Fluted Stem 86-7447 150 mm x 20 mm Universal Fluted Stem 86-7448 150 mm x 22 mm Universal Fluted Stem 86-7449 150 mm x 24 mm Universal Fluted Stem S-ROM Femoral Augments 62-3805 Distal Augment, 5 mm (used on all femur sizes) 62-3810 Distal Augment, 10 mm (used on all femur sizes) 20 mm Cemented Femoral Sleeve 46 mm Fully Porous Femoral Sleeve Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 55 IMPLANT LISTING Universal Femoral Sleeves LPS Universal Inserts (compatible with S-ROM and LPS femurs, must match femur size-to-size) 86-6401 30 mm x 13 mm Cemented Stem 1987-27-112 X-Small 12 mm LPS Universal Insert (used on MBT Revision Trays size 3 and smaller) 1987-27-114 X-Small 14 mm LPS Universal Insert 86-6402 60 mm x 13 mm Cemented Stem 86-6403 30 mm x 15 mm Cemented Stem 86-6404 60 mm x 15 mm Cemented Stem (used on MBT Revision Trays size 4 and larger) 1987-27-126 X-Small 26 mm LPS Universal Insert 86-6468 90 mm x 13 mm Cemented Tapered Stem 1987-27-128 X-Small 28 mm LPS Universal Insert 86-6469 90 mm x 15 mm Cemented Tapered Stem 1987-27-131 X-Small 31 mm LPS Universal Insert 86-6498 120 mm x 13 mm Cemented Tapered Stem 1987-27-212 Small 12 mm LPS Universal Insert 86-6499 150 mm x 13 mm Cemented Tapered Stem 1987-27-214 Small 14 mm LPS Universal Insert (used on MBT Revision Trays size 3 and smaller) (used on MBT Revision Trays size 4 and larger) 1987-27-116 X-Small 16 mm LPS Universal Insert 1987-27-118 X-Small 18 mm LPS Universal Insert 1987-27-121 X-Small 21 mm LPS Universal Insert 1987-27-123 X-Small 23 mm LPS Universal Insert 1987-27-216 Small 16 mm LPS Universal Insert 1987-27-218 Small 18 mm LPS Universal Insert S-ROM Patella 62-1630 30 mm S-ROM Dome Patella 1987-27-221 Small 21 mm LPS Universal Insert 62-1632 32 mm S-ROM Dome Patella 1987-27-223 Small 23 mm LPS Universal Insert 62-1635 35 mm S-ROM Dome Patella 1987-27-226 Small 26 mm LPS Universal Insert 62-1638 38 mm S-ROM Dome Patella 1987-27-228 Small 28 mm LPS Universal Insert 1987-27-231 Small 31 mm LPS Universal Insert 1987-27-312 Medium 12 mm LPS Universal Insert 1987-27-314 Medium 14 mm LPS Universal Insert 1987-27-316 Medium 16 mm LPS Universal Insert 1987-27-318 Medium 18 mm LPS Universal Insert 1987-27-321 Medium 21 mm LPS Universal Insert 1987-27-323 Medium 23 mm LPS Universal Insert 1987-27-326 Medium 26 mm LPS Universal Insert 1987-27-328 Medium 28 mm LPS Universal Insert 1987-27-331 Medium 31 mm LPS Universal Insert 55 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique IMPLANT LISTING MBT Revision Tray Cat. No. Size (mm) A/P M/L Stem Length Tray Thickness 1294-35-110 1 39.0 59.2 61.8 4.8 1294-35-115 1.5 40.7 61.8 61.8 4.8 1294-35-120 2 42.6 64.6 61.8 4.8 1294-35-125 2.5 44.2 67.1 61.8 4.8 1294-35-130 3 45.8 69.6 61.8 4.8 1294-35-140 4 49.3 74.9 61.8 4.8 1294-35-150 5 53.1 80.6 61.8 4.8 1294-35-160 6 57.2 86.8 61.8 4.8 1294-35-215 2+15 42.6 64.6 61.8 15 1294-35-225 2+25 42.6 64.6 61.8 25 1294-35-315 3+15 45.8 69.6 61.8 15 1294-35-325 3+25 45.8 69.6 61.8 25 1294-35-415 4+15 49.3 74.9 61.8 15 1294-35-425 4+25 49.3 74.9 61.8 25 MBT Revision Sleeve Cat. No. Size (mm) A/P M/L Height 1294-54-000 29 26 29 40 1294-54-140 (Cemented) 29 26 29 40 1294-54-100 37 27 37 40 1294-54-110 45 27 45 40 1294-35-120 53 31 53 40 1294-35-130 61 34 61 40 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 55 IMPLANT LISTING MBT Revision Augments Cat. No. Size (mm) Cat. No. Size (mm) 1294-56-110 1-5 1294-56-130 3-5 1294-56-111 1-10 1294-56-131 3-10 1294-56-112 1-15 1294-56-132 3-15 1294-56-115 1.5-5 1294-56-135 4-5 1294-56-116 1.5-10 1294-56-136 4-10 1294-56-117 1.5-15 1294-56-137 4-15 1294-56-120 2-5 1294-56-140 5-5 1294-56-121 2-10 1294-56-141 5-10 1294-56-122 2-15 1294-56-142 5-15 1294-56-125 2.5-5 1294-56-145 6-5 1294-56-126 2.5-10 1294-56-146 6-10 1294-56-127 2.5-15 1294-56-147 6-15 Note: If a tibial sleeve is used, MBT Revision Augments are only compatible with the 29 mm sleeve. 55 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique COMPATIBILITY CHART LPS XX-Small Femoral Component LPS X-Small Femoral Component S-ROM Small Femoral Component S-ROM Medium Femoral Component 66.7 66.7 71.2 and S-ROM X-Small Femoral Component Tray No. M/L 56.6 MBT Revision Tray Size 1 1294-35-110 59.2 3 MBT Revision Tray Size 1.5 1294-35-115 61.8 3 MBT Revision Tray Size 2 1294-35-120 64.6 3 3 3 MBT Revision Tray Size 2.5 1294-35-125 67.1 3 3 3 MBT Revision Tray Size 3 1294-35-130 69.6 3 3 3 3 MBT Revision Tray Size 4 1294-35-140 74.9 3 3 3 3 MBT Revision Tray Size 5 1294-35-150 80.6 3 3 3 3 MBT Revision Tray Size 6 1294-35-160 86.8 3 3 3 3 signifies preferred match LPS Universal inserts must match S-ROM or LPS femoral component size-to-size. For example, XX-Small femoral component = XX-Small polyethylene; Small femoral component = Small polyethylene, etc. Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 55 MBT REVISION PREPARATION CASE CAT. NO. 2178-64-100 Top Tray A B D C F E H G I J L K M N Description Cat. No. A MBT Revision Cemented Stem Reamer, 13 mm 2178-63-185 B Tibial Cutting Block, 2 Degree 2178-40-086 C MBT Revision Reamer Adapter 2178-63-128 D MBT Revision Press-Fit Tibial Punch 2178-63-118 E MBT Revision Cemented Tibial Punch 2178-63-120 F Pin Driver 2490-94-000 G MBT Revision Drill Bushing 2178-63-100 H Pin Puller 96-6515 I SP2 IM Rod, 400 mm 96-6120 J SP2 IM Rod Handle 99-2011 K MBT Revision Cemented Bushing, 13 mm 2178-63-196 L MBT Revision Tapered Press-Fit Reamer 2178-63-104 M MBT Revision Tapered Cemented Reamer 2178-63-106 N Steinman Pins (Package of 10) 86-9117 66 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique MBT REVISION PREPARATION CASE CAT. NO. 2178-64-100 Bottom Tray D H E A B C F I J G Description Cat. No. A MBT Revision 2-Degree Tibial Broaches 29 mm 2178-63-109 MBT Revision 2-Degree Tibial Broaches 37 mm 2178-63-111 MBT Revision 2-Degree Tibial Broaches 45 mm 2178-63-113 MBT Revision 2-Degree Tibial Broaches 53 mm 2178-63-115 MBT Revision 2-Degree Tibial Broaches 61 mm 2178-63-117 B MBT Tray Sleeve Trials 29 mm 2294-54-000 MBT Tray Sleeve Trials 37 mm 2294-54-100 MBT Tray Sleeve Trials 45 mm 2294-54-110 MBT Tray Sleeve Trials 53 mm 2294-54-120 MBT Tray Sleeve Trials 61 mm 2294-54-130 C LCS Completion Tibial Stylus 2178-40-045 D MBT Revision Tibial Broach Handle 96-6521 E Revision Sleeve Impactor 2178-63-124 F Revision Femoral Sleeve/Stem Impactor 2178-63-126 G SP2 Universal Handle 96-6520 H SP2 IM Tibial Alignment Device 96-6315 I MBT Tibial Impactor 9505-01-558 J MBT Revision Tibial View Plate, Size 1 2178-65-110 MBT Revision Tibial View Plate, Size 1.5 2178-65-115 MBT Revision Tibial View Plate, Size 2 2178-65-120 MBT Revision Tibial View Plate, Size 2.5 2178-65-125 MBT Revision Tibial View Plate, Size 3 2178-65-130 MBT Revision Tibial View Plate, Size 4 2178-65-140 MBT Revision Tibial View Plate, Size 5 2178-65-150 MBT Revision Tibial View Plate, Size 6 2178-65-160 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 66 MBT REVISION STEM TRIALS AND INSTRUMENTS CASE CAT. NO. 2178-64-110 Top Tray A B E F G C D Description Cat. No. A Revision Femoral/Tibial Sleeve Clamp 2178-63-134 B SIGMA Tibial Cemented Stem Trial, Sizes 2-3, 13 x 60 mm 86-6502 C SIGMA Tibial Cemented Stem Trial, Sizes 1.5-3, 13 x 30 mm 86-6501 D Stem Trial Extractor 86-5226 E Fluted Tibial Stem Trials – 75 mm 75 x 10 mm 86-6874 75 x 12 mm 86-6875 75 x 14 mm 86-6876 75 x 16 mm 86-6877 75 x 18 mm 86-6878 75 x 20 mm 86-6879 75 x 22 mm 86-6880 75 x 24 mm 86-6881 66 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique MBT REVISION STEM TRIALS AND INSTRUMENTS CASE CAT. NO. 2178-64-110 Top Tray A B E F G C D Description F Fluted Tibial Stem Trials – 115 mm Cat. No. 115 x 10 mm 86-6882 115 x 12 mm 86-6883 115 x 14 mm 86-6884 115 x 16 mm 86-6885 115 x 18 mm 86-6886 115 x 20 mm 86-6887 115 x 22 mm 86-6888 115 x 24 mm 86-6889 G Fluted Tibial Stem Trials – 150 mm 150 x 10 mm 86-6890 150 x 12 mm 86-6891 150 x 14 mm 86-6892 150 x 16 mm 86-6893 150 x 18 mm 86-6894 150 x 20 mm 86-6895 150 x 22 mm 86-6896 150 x 24 mm 86-6897 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 66 MBT REVISION STEM TRIALS AND INSTRUMENTS CASE CAT. NO. 2178-64-110 Bottom Tray A B D E F C Description Cat. No. A Press-Fit Rod Wrench 86-5189 B SIGMA Tibial Cemented Stem Trial, Sizes 2-3, 13 x 60 mm 86-6502 C SIGMA Tibial Cemented Stem Trial, Sizes 1.5-3, 13 x 30 mm 86-6501 D Fluted Tibial Stem Trials – 75 mm 75 x 10 mm 86-6874 75 x 12 mm 86-6875 75 x 14 mm 86-6876 75 x 16 mm 86-6877 75 x 18 mm 86-6878 75 x 20 mm 86-6879 75 x 22 mm 86-6880 75 x 24 mm 86-6881 66 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique MBT REVISION STEM TRIALS AND INSTRUMENTS CASE CAT. NO. 2178-64-110 Bottom Tray A B D E F C Description E Fluted Tibial Stem Trials – 115 mm Cat. No. 115 x 10 mm 86-6882 115 x 12 mm 86-6883 115 x 14 mm 86-6884 115 x 16 mm 86-6885 115 x 18 mm 86-6886 115 x 20 mm 86-6887 115 x 22 mm 86-6888 115 x 24 mm 86-6889 F Fluted Tibial Stem Trials – 150 mm 150 x 10 mm 86-6890 150 x 12 mm 86-6891 150 x 14 mm 86-6892 150 x 16 mm 86-6893 150 x 18 mm 86-6894 150 x 20 mm 86-6895 150 x 22 mm 86-6896 150 x 24 mm 86-6897 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 66 MBT REVISION REAMERS CASE CAT. NO. 2178-64-105 Top Tray A B C D F E G Description Cat. No. A Press-Fit Rod Wrench 86-5189 B I.M. Rod Sleeve Guide, 12 mm 2178-63-187 C I.M. Rod Sleeve Guide, 14 mm 2178-63-188 D LCS Reamer Depth Scale 2178-63-102 E Revision Femoral/Tibial/Sleeve Clamp 2178-63-134 F I.M. Reamer, 9 mm 2178-56-045 G MBT Revision Reamers MBT Revision Reamer, 10 mm 2178-63-170 MBT Revision Reamer, 11 mm 2178-63-171 MBT Revision Reamer, 12 mm 2178-63-172 MBT Revision Reamer, 13 mm 2178-63-173 MBT Revision Reamer, 14 mm 2178-63-174 MBT Revision Reamer, 15 mm 2178-63-175 66 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique MBT REVISION REAMERS CASE CAT. NO. 2178-64-105 Bottom Tray H I A B C D E Description A MBT Revision Reamers MBT Revision Reamer, 16 mm 2178-63-176 MBT Revision Reamer, 17 mm 2178-63-177 MBT Revision Reamer, 18 mm 2178-63-178 MBT Revision Reamer, 19 mm 2178-63-179 MBT Revision Reamer, 20 mm 2178-63-180 MBT Revision Reamer, 21 mm 2178-63-181 MBT Revision Reamer, 22 mm 2178-63-182 MBT Revision Reamer, 23 mm 2178-63-183 MBT Revision Reamer, 24 mm 2178-63-184 B I.M. Rod Sleeve Guide, 16 mm 2178-63-189 C I.M. Rod Sleeve Guide, 18 mm 2178-63-190 D I.M. Rod Sleeve Guide, 20 mm 2178-63-191 E I.M. Rod Sleeve Guide, 22 mm 2178-63-192 F I.M. Rod Sleeve Guide, 24 mm 2178-63-193 G I.M. Rod Sleeve Guide, 26 mm 2178-63-194 H MBT Revision T-Handle 2178-63-137 I Modified Hudson Adapter 2178-63-136 F G Cat. No. Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 66 MBT REVISION WEDGE TRIALS AND INSTRUMENTS CAT. NO. 2178-64-115 Top Tray Size 1 Size 1.5 Size 2 Size 2.5 Size 3 Size 4 Size 5 Size 6/8 5 mm A B C D E F G H 10 mm 15 mm 5 mm 10 mm 15 mm Description Cat. No. A Size 1, 5 mm 2294-56-110 Size 1, 10 mm 2294-56-111 Size 1, 15 mm 2294-56-112 B Size 1.5, 5 mm 2294-56-115 Size 1.5, 10 mm 2294-56-116 Size 1.5, 15 mm 2294-56-117 C Size 2, 5 mm 2294-56-120 Size 2, 10 mm 2294-56-121 Size 2, 15 mm 2294-56-122 D Size 2.5, 5 mm 2294-56-125 Size 2.5, 10 mm 2294-56-126 Size 2.5, 15 mm 2294-56-127 E Size 3, 5 mm 2294-56-130 Size 3, 10 mm 2294-56-131 Size 3, 15 mm 2294-56-132 F Size 4, 5 mm 2294-56-135 Size 4, 10 mm 2294-56-136 Size 4, 15 mm 2294-56-137 G Size 5, 5 mm 2294-56-140 Size 5, 10 mm 2294-56-141 Size 5, 15 mm 2294-56-142 H Size 6/7, 5 mm 2294-56-145 Size 6/7, 10 mm 2294-56-146 Size 6/7, 15 mm 2294-56-147 66 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique MBT REVISION WEDGE TRIALS AND INSTRUMENTS CAT. NO. 2178-64-115 Bottom Tray B C D E F J G A H I L K M N O P Q Description Cat. No. A MBT Revision Tray Trial, Size 1 2294-36-110 MBT Revision Tray Trial, Size 1.5 2294-36-115 MBT Revision Tray Trial, Size 2 2294-36-120 MBT Revision Tray Trial, Size 2.5 2294-36-125 MBT Revision Tray Trial, Size 3 2294-36-130 MBT Revision Tray Trial, Size 4 2294-36-140 MBT Revision Tray Trial, Size 5 2294-36-150 MBT Revision Tray Trial, Size 6 2294-36-160 B MBT Revision Tray Trial with Stem, Size 1 2294-35-110 C MBT Revision Tray Trial with Stem, Size 1.5 2294-35-115 D MBT Revision Tray Trial with Stem, Size 2 2294-35-120 E MBT Revision Tray Trial with Stem, Size 2.5 2294-35-125 F MBT Revision Cutting Block 2178-63-122 G Tibial Wedge Trial Screwdriver 86-0277 H MBT Wedge Cutting Attachment 2178-63-130 I SP2 Alignment Rods 99-1016 J Tibial Trial Alignment Handle 96-6330 K MBT Revision Trial Post 2178-63-132 L Modular Plus Torque Driver 86-0284 M MBT Tray Trial Fixation Pins 2178-30-123 N MBT Revision Tray Trial with Stem, Size 3 2294-35-130 O MBT Revision Tray Trial with Stem, Size 4 2294-35-140 P MBT Revision Tray Trial with Stem, Size 5 2294-35-150 Q MBT Revision Tray Trial with Stem, Size 6 2294-35-160 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 66 SIGMA HP REVISION FEMORAL PREP INSTRUMENT CASE CAT. NO. 2011-03-049 Bottom Tray H B C D E F G I J A M K L Description Cat. No. A Visualization Wing 96-6530 B Completion Revision Femoral Tapered Reamer 2178-60-030 C Universal Revision Femoral Broach Reamer 96-1671 D Universal Revision Femoral Broach 31 mm 96-1683 E Universal Revision Femoral Broach 34 mm 96-1684 F Universal Revision Femoral Broach 40 mm 96-1685 G Universal Revision Femoral Broach 46 mm 96-1686 H SIGMA HP Revision Adapter Removable Shaft 2011-03-029 I SIGMA HP Distal Femoral Resection Guide 9505-01-235 J SIGMA HP Distal Femoral Connector 9505-01-238 K SIGMA HP Revision Distal Femoral Block 9505-01-239 L SIGMA HP Distal Femoral Alignment Guide 9505-01-234 M Universal Revision Femoral Broach Handle 96-1682 77 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique SIGMA HP REVISION FEMORAL TRIAL INSTRUMENT CASE CAT. NO. 2011-03-050 Top Tray A B C D E F G H I J O P N Q R M K S L T Description Cat. No. A LCS/SIGMA Revision Femoral Sleeve Trial 20 mm 2294-53-100 B LCS/SIGMA Revision Femoral Sleeve Trial 31 mm 2294-53-110 C LCS/SIGMA Revision Femoral Sleeve Trial 34 mm 2294-53-120 D LCS/SIGMA Revision Femoral Sleeve Trial 40 mm 2294-53-130 E LCS/SIGMA Revision Femoral Sleeve Trial 46 mm 2294-53-140 F Modular Plus Torque Driver 86-0284 G SIGMA HP Revision TC3 Box Trial Size 2 2011-03-011 H SIGMA HP Revision TC3 Box Trial Size 2.5 2011-03-012 I SIGMA HP Revision TC3 Box Trial Size 3 2011-03-013 J SIGMA HP Revision TC3 Box Trial Size 4 2011-03-014 K SIGMA HP Revision TC3 Box Trial Size 5 2011-03-015 L SIGMA HP Revision Femoral Adapter Shift Tool 2011-03-057 M SIGMA Femoral Adapter Sleeve Bolt Trial Neutral 2011-03-052 N SIGMA Femoral Adapter Stem Bolt Trial Neutral 2011-03-051 O Femoral Augment Plug Puller 86-5151 P SP2 Torque Driver Handle Extension 96-6301 Q Large Fragment Screwdriver Shank 8242-19-000 R 2.0 Nm Torque-limiting Screwdriver 2141-18-001 S Femoral Adapter Torque Wrench 96-1673 T Femoral Adapter Holding Clamp 96-1674 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 77 LPS HINGE INSERT TRIALS A B C Description A Xsm Hinged Insert Trials Cat. No. LPS Hinge Insert Trial 12 mm, Xsm 2987-22-112 LPS Hinge Insert Trial 14 mm, Xsm 2987-22-114 LPS Hinge Insert Trial 16 mm, Xsm 2987-22-116 LPS Hinge Insert Trial 18 mm, Xsm 2987-22-118 LPS Hinge Insert Trial 21 mm, Xsm 2987-22-121 LPS Hinge Insert Trial 23 mm, Xsm 2987-22-123 LPS Hinge Insert Trial 26 mm, Xsm 2987-22-126 LPS Hinge Insert Trial 28 mm, Xsm 2987-22-128 B Sm Hinged Insert Trials LPS Hinge Insert Trial 12 mm, Sm 2987-22-212 LPS Hinge Insert Trial 14 mm, Sm 2987-22-214 LPS Hinge Insert Trial 16 mm, Sm 2987-22-216 LPS Hinge Insert Trial 18 mm, Sm 2987-22-218 LPS Hinge Insert Trial 21 mm, Sm 2987-22-221 LPS Hinge Insert Trial 23 mm, Sm 2987-22-223 LPS Hinge Insert Trial 26 mm, Sm 2987-22-226 LPS Hinge Insert Trial 28 mm, Sm 2987-22-228 C Med Hinged Insert Trials LPS Hinge Insert Trial 12 mm, Med 2987-22-312 LPS Hinge Insert Trial 14 mm, Med 2987-22-314 LPS Hinge Insert Trial 16 mm, Med 2987-22-316 LPS Hinge Insert Trial 18 mm, Med 2987-22-318 LPS Hinge Insert Trial 21 mm, Med 2987-22-321 LPS Hinge Insert Trial 23 mm, Med 2987-22-323 LPS Hinge Insert Trial 26 mm, Med 2987-22-326 LPS Hinge Insert Trial 28 mm, Med 2987-22-328 77 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique LPS HINGE INSERT TRIALS A C B D Description A XXSm Hinged Insert Trials Cat. No. LPS Hinge Insert Trial XX-Sm 12 mm 2987-22-012 LPS Hinge Insert Trial XX-Sm 14 mm 2987-22-014 LPS Hinge Insert Trial XX-Sm 16 mm 2987-22-016 LPS Hinge Insert Trial XX-Sm 18 mm 2987-22-018 LPS Hinge Insert Trial XX-Sm 21 mm 2987-22-021 LPS Hinge Insert Trial XX-Sm 23 mm 2987-22-023 B 31mm Hinged Insert Trials LPS Hinge Insert Trial 31 mm, Xsm 2987-22-131 LPS Hinge Insert Trial 31 mm, Sm 2987-22-231 LPS Hinge Insert Trial 31 mm, Med 2987-22-331 C MBT Rev Trial Post 2178-63-132 D LPS Hinge Pin Trial 2987-15-000 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 77 S-ROM HINGE FEMORAL INSTRUMENTS B E I J K L M N F H A G C D Description Cat. No. A S-ROM Driver Femoral 633802 B S-ROM Knee Aug Blk Cem Clamp 633810 C S-ROM Separator,Femoral Sleeve 634182 D Sleeve/Stem Extractor 86-5226 E S-ROM NRH Dist Fem Aug Trl 5 mm 633785 F S-ROM NRH Dist Fem Aug Trl 10 mm 633790 G S-ROM NRH Hinge Pin Trial 634133 H S-ROM Universal Handle 633806a I S-ROM NRH Fem Trial Right Med 634131r J S-ROM NRH Fem Trial Left Med 634132l K S-ROM NRH Fem Trial Right Small 634151l L S-ROM NRH Fem Trial Left Small 634151r M S-ROM NRH Fem Trial Right Xsmall 634161 N S-ROM NRH Fem Trial Left Xsmall 634161 77 DePuy Synthes Joint Reconstruction S-ROM® Noiles Rotating Hinge Surgical Technique S-ROM HINGE FEMORAL INSTRUMENTS F E A G C H D B J I Description Cat. No. A S-ROM Guide Anterior Reference 633370a B S-ROM Xsm/Sm A/P Block 2163-11-001 C S-ROM Med A/P Block 2163-11-004 D S-ROM NRH Fem Box Cut Guide 633385 E S-ROM Box Cut Guide Augment Space, 5 mm 633305a F S-ROM Box Cut Guide Augment Space, 10 mm 633306a G SP2 Removable Handles 96-6147 H Femoral Locating Device Outrigger 96-6112 I Femoral Locating Device 96-6110 J Distal Femoral Cutting Block 96-6115 Surgical Technique S-ROM® Noiles Rotating Hinge DePuy Synthes Joint Reconstruction 77 S-ROM® MODULAR TOTAL KNEE SYSTEM | NOILES™ ROTATING HINGE KNEE SYSTEM IMPORTANT: PRECAUTIONS: This Essential Product Information sheet does not include all of the information necessary for selection and use of a device. Please see full labeling for all necessary information. The NOILES Rotating Hinge Knee is designed to articulate from 6 degrees hyperextension to 110 degrees flexion. If, due to grossly inadequate soft tissue integrity, flexion beyond 90 degrees causes luxation of the plateau assembly out of the tibial base, the patient must have a knee brace posto-peratively to limit flexion to 90 degrees. In such cases, the surgeon should consider closing the wound with the knee in full extension. INDICATIONS AND USAGE: The NOILES Rotating Hinge Knee is indicated for use with PMMA bone cement in primary or revision cases in patients: • who have reached skeletal maturity and The size of the tibial plateau assembly must correspond with the size of the femoral component. • for whom the surgeon has decided to resect both cruciate ligaments or whose cruciate ligaments are absent or incompetent and The size of the tibial augmentation block must correspond to the size of the tibial base. • who exhibit insufficiency of lateral/collateral ligaments and other soft supporting tissue due to the following conditions: Femoral sleeves are required when using femoral stem extensions. A femoral plug is required with the femoral sleeve when a femoral stem extension is not used. •R heumatoid arthritis, osteoarthritis, post-traumatic arthritis, and arthritis secondary to a variety of diseases and anomalies • Failure of a previous knee reconstruction procedure A tibial cap is required with the tibial sleeve when a tibial stem extension is not used. • Trauma Tibial augmentation blocks cannot be used when tibial sleeves are being used. CONTRAINDICATIONS: 1. Active infection or history of general infections or local infectious disease. 2. Vascular insufficiency, muscular atrophy or neuromuscular disease in the affected limb. 3. Advanced loss of osteochondral structure that would preclude proper fixation of the prosthesis. 4. Tumors of the supporting bone structure, systemic and metabolic disorders leading to progressive deterioration of solid bone support. 5. Drug or alcohol addiction, or limiting neuropathic disease. 6. Skeletal immaturity. 7. Obesity or very active lifestyle that can produce loads on the prosthesis that can lead to failure of the fixation of the device or device itself. 8. Allergic reaction to the implant materials. 9. Inadequate flexor and extensor mechanism necessary to achieve a functional prosthetic joint. WARNINGS: Improper prosthesis selection or alignment, inadequate fixation, use where contraindicated or in patients whose medical, physical, mental, or occupational conditions will likely result in extreme stresses to the implant, may result in premature failure due to loosening, fracture, or wear. Post-operative care is extremely important. The patient should be instructed on the limitations of the device and should be cautioned regarding load bearing, ranges of motion, and activity levels permissible. Early motion and load bearing should be carefully controlled. The S-ROM tibial base, tibial sleeve, tibial stem extension, and tibial augmentation blocks may not be used with the NOILES Posterior Stabilized Knee. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. The third party trademarks used herein are trademarks of their respective owners. DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46582 T. +1 (800) 366-8143 www.depuysynthes.com © DePuy Synthes Joint Reconstruction, a division of DOI 2014. All rights reserved. 0612-85-510 (Rev. 3) EO 1/14 An implant should never be reused. Any implant, once used, should be discarded. Even though it appears undamaged, it may have small defects and/or internal stress patterns that may lead to failure. Likewise, a new implant should be handled carefully to avoid damage that could compromise the integrity of the device and cause early failure or loosening. The wear rate of prosthesis contact surfaces is greatly accelerated if loose fragments of bone cement become detached and act as an abrasive in the bearing surfaces. When using bone cement, care should be taken to remove all excess cement from the periphery of the implant. DePuy’s Single Use devices have not been designed to undergo or withstand any form of alteration, such as disassembly, cleaning or re-sterilization, after a single patient use. Reuse can potentially compromise device performance and patient safety. ADVERSE EFFECTS: Fracture may occur due to improper preparation of the implant site or if excessive force is used during seating of the implant. Transient peroneal palsy has been reported following total knee arthroplasty, especially after correction of severe flexion or valgus deformities. Patients have complained of persistent pain and stiffness following total knee arthroplasty. In addition, patellar tendon rupture, femoral-tibial subluxation or dislocation, and persistent ligamentary laxity have been reported with the use of total knee implants. Infection and loosening have been reported following total joint arthroplasty, as have wear and failure due to fracture of knee prosthesis components. Histological reactions have been reported as an apparent response to exposure to a foreign material. The actual clinical significance of these reactions is unknown. Serious adverse side effects may necessitate surgical intervention.
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