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2017-11-02
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ACTIS™ TOTAL HIP SYSTEM: EARLY CLINICAL RESULTS Rodrigo Diaz, MD, Franchise Medical Director | DePuy Synthes Jack Mantel, BA (Hons), Associate Director, Health Economics and Market Access | DePuy Synthes Kris Lee, MPM, Staff Clinical Research Scientist | DePuy Synthes Introduction Total Hip Arthroplasty (THA) relieves pain and restores function for patients suffering from osteoarthritis. Following regulatory clearance/approval, DePuy Synthes introduced the ACTIS™ Total Hip System, a collared titanium primary hip stem. As a part of our commitment to monitoring the performance of our products, DePuy Synthes engaged in a clinical evaluation to track early results of the ACTIS Total Hip System. The purpose of this report is to present those results up to one year follow-up. The ACTIS Total Hip System was designed to provide surgeons with a prosthesis system to aid tissue sparing surgical approaches, such as the anterior approach. Such approaches have been shown to provide benefit to the patient in the short term after surgery,1 may improve outcomes1-11 and improve the patient experience.1-6,9 In this short term evaluation of 1,183 patients, five adverse events were reported. There were no instances of dislocation, no radiolucent lines, and no signs of loosening. The ACTIS Total Hip System is a fit and fill stem, with triple-tapered geometry. The stem is tapered in three separate planes to aid in short and long-term stability (see Figure 1). The ACTIS Total Hip System is tapered from proximal to distal in the anterior/posterior plane, proximal to distal in the medial/lateral plane and lateral to medial in the transverse or axial plane. The ACTIS Total Hip System was designed to increase 1 mm in the anterior/posterior dimension in the horizontal plane consistently between each size stem. Additionally, the anterior/posterior taper of the ACTIS Total Hip System increases 0.25 degrees per size and designed to achieve proper fit across the entire range of stem sizes. Features of the implant as well as instrumentation are designed to allow for prosthesis insertion with minimal soft tissue, pelvis, and incision impingement. The ACTIS Total Hip System features DUOFIX™ Coating on the proximal portion of the stem, including the underside of the collar, to allow for biological fixation. The ACTIS Total Hip System features a medial collar and triple taper geometry, that have been shown to improve primary stability of the stem while also offering a solution for a broader range of patient anatomies.12,13 A medial collar has been shown to provide the opportunity for improved initial stability,12 resistance to early subsidence, and more physiologic compressive loads in the medial calcar.22 Improved outcomes are supported by enhanced initial implant stability.12,13 Horizontal plane grows 1 mm in the A/P per size Figure 1 Methods Results The ACTIS Total Hip System clinical evaluation and data collection period was established to assess the early post-operative performance of the system. DePuy Synthes reviewed the data generated at staged time points to evaluate whether the ACTIS Total Hip System was performing as expected, and to make informed decisions about the broader commercial release of the system. A committee comprised of the DePuy Synthes Medical Director, DePuy Synthes Medical Safety Officer, Clinical Research, R&D, and the ACTIS Total Hip System designing surgeons was responsible for reviewing the data prior to proceeding to the next stage of the evaluation. The data reviewed at each stage of the evaluation included surgeon feedback, any reported adverse events, and post-operative radiographs. Radiographic Review: Three hundred and forty-three X-Rays in 325 patients were reviewed by Medical Safety Staff from Medical Affairs and Medical Safety with no adverse findings to report. No radiolucent lines and no signs of radiographic loosening were observed (see Figure 2). In total, data was reviewed from 1,183 ACTIS Total Hip Systems. This included 670 stems implanted by four designing surgeons (3-US, 1-Austria), 93 subjects enrolled in a company sponsored clinical study and 420 ACTIS Total Hip Systems implanted by the early evaluators group (see Table 1). Adverse Events: The following adverse events were reported during the final review. Two intra-operative calcar fractures occured, and were treated intra-operatively, with uneventful patient recoveries. One periprosthetic fracture occured at 2.5 weeks post-op, after the patient bent down. No surgery was performed, and only restricted weight bearing was directed. This patient was last seen nearly four months post-surgery, and had recovered without complications. A femoral perforation occurred with the broach as a fellow was broaching in the wrong direction. It was identified, the broach was redirected, and the patient was placed on protected weight bearing. No reamers or other tools were used. The surgeon reported that the patient had returned to full activity by 6 weeks post-operative. Clinical evaluation period Design Surgeons 4 Sites (3-US, 1-Austria) Jan Feb Clinical Study 10 Sites Apr US Early Evaluation 30 Sites Jun Sept 1st ACTIS Clinical Evaluation Total Hip System Review #1 Implantation 30 Patients Implanted Table 1 2 Oct Clinical Evaluation Review #2 309 Patients Implanted 2016 U.S. Commercial Launch Jan Feb Clinical Evaluation Review #3 1,183 Patients Implanted 2017 Conclusion Although this is a very early assessment of the outcomes of the ACTIS Total Hip System, the absence of reported thigh pain, good clinical results, and low prevalence of other adverse events are positive early findings. These early clinical results indicate the ACTIS Total Hip System performance is satisfactory. Long term clinical follow-up is ongoing. A/P Pre-operative image. A/P Pre-operative image. 1 Year A/P post-operative image of the ACTIS Hip System on the same patient’s left hip. Lack of radiolucent lines demonstrates excellent fixation. Figure 2 One study subject reported hip pain at 50 and 60 days post-operatively which required no treatment and was resolved without any complications. One study subject had a cellulitis at 20 days post-operatively, one study subject reported erythema at 36 days post-operative, and another study subject reported muscle spasm around their hip at 30 days post-operatively. Discussion Post-operative thigh pain has been reported following Cementless THA with many different stem designs.14-16 A simple survey of the available literature demonstrates reported thigh pain rates varying between <1% and 9.5%.16,20 In 1,183 ACTIS Total Hip Systems, some out to 1 year post-operative, there has been only one report of thigh pain from within the ACTIS Total Hip System implantations, and this case has resolved with no additional treatment required. From this same group of 1,183 subjects, two intra-operative calcar fractures occurred, which is less than the 2.9%-27.8% reported in literature.21 No radiolucent lines and no signs of loosening were observed. These early findings indicate excellent stability with the ACTIS Total Hip System. 3 References 1. Barrett WP, et al. Prospective Randomized Study of Direct Anterior vs Postero-Lateral Approach for Total Hip Arthroplasty. The Journal of Arthroplasty. 2013; 28: 1634-1638. 2. Zawadsky MW, et al. Early Outcome Comparison Between the Direct Anterior Approach and the Mini-Incision Posterior Approach for Primary Total Hip Arthroplasty: 150 Consecutive Cases. The Journal of Arthroplasty. 2014; 29: 1256-1260. 3. Christensen CP, et al. Comparison of Patient Function during the First Six Weeks after Direct Anterior or Posterior Total Hip Arthroplasty (THA): A Randomized Study. The Journal of Arthroplasty 2015; (30): 94-97. 4. Petis SM, et al. In Hospital Cost Analysis of THA: Does Surgical Approach Matter? The Journal of Arthroplasty. 2016; 31: 53-58. 5. Martin CT, et al. A Comparison of Hospital Length of Stay and Short-term Morbidity Between the Anterior and the Posterior Approaches to Total Hip Arthroplasty. The Journal of Arthroplasty. 2013; 28: 849-854. 6. Alecci V, et al. Comparison of primary total hip replacements performed with a direct anterior approach versus the standard lateral approach: perioperative findings. J Orthopaed Traumatol. 2010;12: 123-9. 7. Higgins BT, et al. Anterior vs. posterior approach for THA, a systematic review and meta-analysis. The Journal of Arthroplasty. 2015; 30: 419–434. 8. Restrepo C, et al. Prospective Randomized Study of Two Surgical Approaches for Total Hip Arthroplasty. The Journal of Arthroplasty. 2010; 25(5): 671-9. 9. Rodriguez JA, et al. Does the Direct Anterior Approach in THA Offer Faster Rehabilitation and Comparable Safety to the Posterior Approach? Clin Orthop Relat Res. 2013; 472: 455-463. 10. Vail TP, et al. Approaches in Primary THA. The Journal of Bone and Joint Surgery. 2009; (91): 10-12. 11. Bourne MH, et al. A comparison between direct anterior surgery of the hip (DASH) and the anterolateral (AL) surgical approach to THA: Postoperative outcomes. 2010 AAOS New Orleans, LA, Poster #014. 12. Demey G, Fary C, Lustig S, et. al. Does a Collar Improve the Immediate Stability of Uncemented Femoral Hip Stems in Total Hip Arthroplasty? A Bilateral Comparative Cadaver Study. The Journal of Arthroplasty. 2011; 26(8): 1549-55. 13. Hamburg University Actis Cadaveric Stability Testing. Data on File (Adaptiv #103156243). 14. Brown TE, Larson B, Shen F, Moskal. Thigh Pain after Cementless Total Hip Arthroplasty: Evaluation and Management. JT J Am Acad Orthop Surg. 2002; 10: 385-392. 15. Faraj AA, Yousuf M. Anterior thigh pain after cementless total hip arthroplasty. Int Orthop (SICOT). 2005; 29: 149-151. 16. Lavernia C, D’Apuzzo M, Hernandez V, Lee D. Thigh pain in primary total hip arthroplasty: The effects of elastic moduli. Journal of Arthroplasty. 2004; 19 (7): 10-16. 17. Healy W.L., Tilzey J.F., Iorio R., Specht L.M., Sharma S. Prospective, Randomized Comparison of Cobalt-Chrome and Titanium Trilock Femoral Stems. Journal of Arthroplasty. 2009; 24(6): 831-6, 18. Cooper HJ, Jacob AP, Rodriguez JA. Distal fixation of proximally coated tapered stems may predispose to a failure of osteointegration. Journal of Arthroplasty. 2011; 26(6): 78-83. 19. Ulivi M, Orlandini L, Bassi M, Meroni V, Sansone V. Thigh pain incidence at 24 months after total hip arthroplasty with the short stem Tri-Lock BPS, Gription coating: A prospective study. Journal of Orthopaedics and Traumatology. 2012: 97th National Congress of the Italian Society of Orthopaedics and Traumatology Conference Publication: 13: S36. 20. Ulivi M, Orlandini L, Meroni V, Bassi M, Sansone V. Thigh pain after cementless total hip arthroplasty with the short stem Tri-Lock BPS, Gription coating. Journal of Orthopaedics and Traumatology. 2013; 98th National Congress of the Italian Society of Orthopaedics and Traumatology Conference Publication: 14 (1 SUPPL. 1): S98-9. 21. Ponzio DY, Shahi A, Park AG, Purtill JJ. Intraoperative Proximal Femoral Fracture in Primary Cementless Total Hip Arthroplasty. Journal of Arthroplasty. 2015; 30: 1418-1422. 22. Meding JB, Ritter MA, Keating M, Faris, PM. Comparison of Collared and Collarless Femoral Components in Primary Uncemented Total Hip Arthroplasty. The Journal of Arthroplasty. 1997; 12(3): 273-80. Not all products are currently available in all markets Johnson & Johnson Medical Limited PO BOX 1988, Simpson Parkway, Livingston, West Lothian, EH54 0AB, United Kingdom. Incorporated and registered in Scotland under company number SC132162. DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46582 USA Tel: +1 (800) 366 8143 Fax: +1 (574) 669-2530 DePuy International Ltd St Anthony’s Road Leeds LS11 8DT England Tel: +44 (0)113 270 0461 depuysynthes.com © DePuy Synthes 2017. All rights reserved. DSUS/JRC/0717/2231 DePuy (Ireland) Loughbeg Ringaskiddy Co. Cork Ireland Tel: +353 21 4914 000 Fax: +353 21 4914 199 0086
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