Abstract
Objectives:
Rotator cuff repair (RCR) remains an area needing further research to optimize patient outcomes postoperatively. This study investigates a novel allogenic, acellular, biphasic cancellous bone scaffold that lies between the tendon and bone in an RCR. The purpose of this study is to assess the efficacy of this graft in improving the integration of soft tissue to bone post RCR.
Methods:
Ten patients were consented to receive the BioEnthesis graft prior to undergoing arthroscopic RCR. Patients received an MRI and patient reported outcomes (PROs) preoperatively and at 6 and 12-months postoperatively. A control cohort was obtained from a previous randomized controlled trial and matched in a 2:1 ratio by sex, tear size, and number of anchors used in the repair. The control cohort had an MRI at 12-months only. Two reviewers (R.D., A.B.Y.) independently graded each MRI according to the Sugaya classification assessing post-operative rotator cuff repair as well as a binomial assessment for the presence of a retear.
Results:
Analysis included 10 patients (7 male, 3 female) receiving the BioEnthesis graft and 20 Control patients (14 male, 6 female). The BioEnthesis cohort was significantly older than the Control cohort (69.7 ± 5.9 vs 56.11 ± 9.4; p<0.001). At 12-months postoperatively, there was a trend in the average Sugaya score graded on MRI favoring the BioEnthesis over the Control cohort (2.28 ± 1.2 vs 3.3 ± 1.09; p=0.054). BioEnthesis patients had a lower rate of retear on 12-month MRI, but this difference was not significant (29% vs 45%; p=0.23). No significant differences were found for PRO’s at any time point. VAS was not assessed for the control group, however, BioEnthesis patients significantly improved from pre-operative to 12-months post-operative (5.0 ± 2.4 to 0.875 ± 0.8; p<0.001). BioEnthesis patients experienced significant strength increases in abduction, scapular plane abduction, and external rotation at 6 and 12-months postoperatively.
Conclusions:
The BioEnthesis graft is a safe graft option that may reduce the risk of retear and help the integration of tendon to bone in arthroscopic RCR.
