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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.

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

Figure 1

Horizontal plane grows 1 mm in the A/P per size

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.

Methods

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.

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).

Results

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).

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

Table 1

Jan Feb Apr Jun Sept Oct Jan Feb

2016 2017

Design Surgeons

4 Sites (3-US,

1-Austria) Clinical Study

10 Sites

US Early Evaluation

30 Sites

U.S.

Commercial

Launch

1st ACTIS

Total Hip System

Implantation

Clinical Evaluation

Review #1

30 Patients

Implanted

Clinical Evaluation

Review #2

309 Patients

Implanted

Clinical Evaluation

Review #3

1,183 Patients

Implanted

2

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.

Figure 2

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.

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.

© DePuy Synthes 2017. All rights reserved. DSUS/JRC/0717/2231

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