Treatment of Partial-Thickness Rotator Cuff Tears With a Resorbable Bioinductive Bovine Collagen Implant: 1-Year Results From a Prospective Multicenter Registry

Abstract

Background: Surgical treatment of partial-thickness rotator cuff tears remains challenging and controversial, with several traditional options including debridement with acromioplasty, transtendon or in situ repair, and take-down and repair. A resorbable bioinductive bovine collagen implant has shown promise as an alternative treatment option for partial-thickness tears.

Purpose: Data from a registry were analyzed to further establish that the implant contributes to improved patient-reported outcome (PRO) scores across a large number of patients treated for partial-thickness rotator cuff tears.

Study design: Case series; Level of evidence, 4.

Methods: A total of 19 centers in the United States enrolled patients >21 years old with partial-thickness tears of the rotator cuff in a comprehensive prospective multicenter registry. PRO scores were recorded preoperatively and postoperatively at 2 and 6 weeks, 3 and 6 months, and 1 year: American Shoulder and Elbow Surgeons, Single Assessment Numeric Evaluation, Veterans RAND 12-Item Health Survey (physical and mental component scores), and Western Ontario Rotator Cuff scores. Revisions were reported throughout the study.

Results: The registry included 272 patients with partial-thickness tears (49 grade 1 tears, 101 grade 2 tears, and 122 grade 3 tears), 241 who underwent isolated bioinductive repair (IBR; collagen implant placed after bursectomy without a traditional rotator cuff repair), and 31 who had take-down and repair with bioinductive augmentation. Patients experienced statistically significant and sustained improvement from baseline for all PRO scores beginning at 3 months. Among patients with grade ≥2 tears, those with take-down and repair had significantly inferior scores at 2 and 6 weeks for most PRO scores as compared with those who underwent IBR, but the difference was no longer significant at 1 year for all but the physical component score of the Veterans RAND 12-Item Health Survey. There were 11 revisions, which occurred at a mean ± SD of 188.7 ± 88.0 days after the index surgery. There were no infections.

Conclusion: This registry analysis further establishes across a large data set that this resorbable bioinductive bovine collagen implant improves PROs in all grades of partial-thickness tears, whether used as IBR or in conjunction with take-down and repair. IBR may offer improved early clinical outcomes (≤6 weeks) and comparable outcomes at 1 year when compared with a more invasive "take-down and repair" approach.

Keywords: isolated bioinductive repair; partial thickness; resorbable bioinductive bovine collagen implant; rotator cuff repair; take-down and repair.

Conflict of interest statement

One or more of the authors has declared the following potential conflict of interest or source of funding: The article-processing charge for this study was provided by Smith & Nephew. B.D.B. has received research funding, consulting fees, and speaking fees from Smith & Nephew. S.K.B. has received research funding from Smith & Nephew; consulting fees from Arthrex, Arthrosurface, Ceterix, Davol, Medical Device Business Services, Smith & Nephew, Trice Medical, and Wright Medical; and speaking fees from Arthrex, Davol, Pacira Pharmaceuticals, Pinnacle, Smith & Nephew, and Zimmer Biomet. R.J.K. has received research funding from Smith & Nephew and Zimmer Biomet; education payments from Alpha Orthopedic Systems; consulting fees from Ignite Orthopedics, Medical Device Business Services, Smith & Nephew, Stryker, and Zimmer Biomet; and speaking fees from DJO, Encore Medical, Stryker, and Zimmer Biomet. S.M. has received consulting fees from Arthrex, Artos, BD/BARD, Ethicon US, Exactech, Medical Device Business Services, Pacira Pharmaceuticals, Smith & Nephew, Trice Medical, and Zimmer Biomet; speaking fees from Arthrex and Flexion Therapeutics; royalties from Trice Medical; honoraria from Davol; and hospitality fees from Liberty Surgical. S.M. also has stock/stock options in Artos. B.A.S. has a family member who is an employee of Smith & Nephew. B.A.S. also has received research funding from Arthrex, Smith & Nephew, and Stryker; consulting fees from FH Orthopedics; honoraria from Encore Medical; and royalties from FH Orthopedics. S.W.T. has received research funding, consulting fees, speaking fees, and royalties from Smith & Nephew and consulting fees and speaking fees from Exactech and Xiros. L.F.M. has received educational support from Arthrex; consulting fees from Active Implants, Ceterix, Embody, Flexion Therapeutics, Medical Device Business Services, Mininvasive, Smith & Nephew, and Zimmer Biomet; speaking fees from Smith & Nephew and Sanofi-Aventis; and royalties from Embody. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto.

© The Author(s) 2021.

Figures

Figure 1.

Placement of the implant with the single-use disposable device. Image provided courtesy of Smith & Nephew.

Figure 2.

(A) Bursal- and (B) articular-sided views of a hybrid high-grade partial-thickness tear treated with (C) isolated bioinductive repair using the resorbable bovine collagen implant.