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General Orthopaedics

EVALUATION OF IMPLANT FIXATION IN REVERSE TOTAL SHOULDER ARTHROPLASTY: A PROSPECTIVE, RANDOMIZED CLINICAL TRIAL

International Society for Technology in Arthroplasty (ISTA) 31st Annual Congress, London, England, October 2018. Part 1.



Abstract

Introduction

Total shoulder arthroplasty is the fastest growing joint replacement in recent years, with projected compound annual growth rates of 10% for 2016 through 2021 – higher than those of both the hip and knee combined. Reverse total shoulder arthroplasty (RTSA) has gained particular interest as a solution for patients with irreparable massive rotator cuff tears and failed conventional shoulder replacement, for whom no satisfactory intervention previously existed. As the number of indications for RTSA continues to grow, so do implant designs, configurations, and fixation techniques. It has previously been shown that continuous implant migration within the first two years postoperatively is predictive of later loosening and failure in the hip and knee, with aseptic loosening of implant components a guaranteed cause for revision in the reverse shoulder. By identifying implants with a tendency to migrate, they can be eliminated from clinical practice prior to widespread use. The purpose of this study is to, for the first time, evaluate the pattern and magnitude of implant component migration in RTSA using the gold standard imaging technique radiostereometric analysis (RSA).

Methods

Forty patients were prospectively randomized to receive either a cemented or press-fit humeral stem, and a glenosphere secured to the glenoid with either autologous bone graft or 3D printed porous titanium (Aequalis Ascend Flex, Wright Medical Group, Memphis, TN, USA) for primary reverse total shoulder arthroplasty. Following surgery, partients are imaged using RSA, a calibrated, stereo x-ray technique, at 6 weeks (baseline), 3 months, 6 months, 1 year, and 2 years.

Migration of the humeral stem and glenosphere at each time point is compared to baseline. Preliminary results are presented, with 15 patients having reached the 6-month time point by presentation.

Results

Implant migration of ten participants at the 3-month time point is presented. Maximum total point motion (MTPM) is a measure of translation and rotation of the point on the implant that has moved the most from baseline. Average MTPM ± SD of the humeral stem is 1.18 ± 0.65 mm and 0.98 ± 0.46 mm for press-fit (n = 6) and cemented (n = 4) stems, respectively; and 0.25 ± 0.09 mm and 0.47 ± 0.24 mm for bone graft (n = 4) and porous titanium (n = 6) glenosphere fixations, respectively, at the 3-month time point.

Conclusion

There is a trend towards increased migration with the use of press-fit humeral stems and porous titanium glenosphere fixation, though no conclusions can be made from the current sample size. Further, though differences in migration magnitude may be observed at early postoperative time points, it is expected that all fixation techniques will show stability from 1 to 2 years postoperatively.


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