Abstract
Objectives:
Arthroscopic rotator cuff repair has been demonstrated to provide reliable clinical outcomes, but the rate of retear remains high (11% to 94%). Retears are associated with poorer outcomes and the majority of retears have been shown to occur within 6 months after surgical repair. Improving the mechanical and/or biological environment during index repair is a common strategy utilized to reduce retear rate. Biofiber© is a bi-layer, absorbable reinforced poly (4)-hydroxybutyrate scaffold that can be used to reinforce rotator cuff repair. Rotator cuff repairs augmented with Biofiber appear to have improved biomechanical properties as compared to standard repair constructs in cadaveric study. Therefore, BioFiber augmented rotator cuff repair may be a viable consideration for patients with larger tears, poorer tissue quality, or in revision repairs. The purpose of this prospective multi-center clinical trial is to evaluate the clinical outcomes and rates of successful healing by ultrasound evaluation in patients undergoing augmented arthroscopic rotator cuff repair using a BioFiber scaffold.
Methods:
A cohort of 50 patients were prospectively enrolled from three study sites in the US (2 sites) and France (1 site). Patients with an imaging demonstrated and arthroscopically confirmed full-thickness rotator cuff tear who underwent arthroscopic rotator cuff repair augmented with a BioFiber scaffold were included in the study. All patients were evaluated clinically at baseline prior to surgery, and subsequently at 6 months and 1 year post-operatively using functional outcomes evaluation (Constant Score and WORC Index), ROM, and strength testing. Ultrasound evaluation at 6 months and 1 year was also carried out to assess repair integrity.
Results:
The average patient age of the cohort was 61 ± 9 years with an average BMI of 28.4. There were 27 female (54%) and 23 male (46%) patients; 10% of those enrolled were worker's compensation patients, 12% were undergoing revision rotator cuff repair. The average AP tear length was 25.2mm ± 1.8mm with an average retraction of 17.1mm ± 1.2mm from the greater tuberosity. Arthroscopic repairs were achieved in all 50 patients using either double-row (78%) or single-row (22%) constructs. The total surgical time for the procedure averaged 77 minutes, with a mean time required for placement of the Biofiber scaffold of 17 minutes. At 6 months post-operatively, the mean adjusted Constant Score was 94.0 (baseline 61.0) and the mean WORC Index was 82.1 (baseline 37.5). Ultrasound evaluation demonstrated intact repairs in 96% of the evaluated patients at the 6 month time point, with no additional evidence of repair failure at 1 year.
Conclusion:
This interim analysis suggests that reinforcement of rotator cuff repairs with Biofiber may result in a mechanically superior repair leading to a high rate of tendon healing. Tear size and quality of repair have been the best predictors for tendon healing in rotator cuff surgery, with recent studies demonstrating improved Constant scores when tendon healing is seen on ultrasound. This cohort had 96% rate of repair integrity on ultrasound evaluation. Furthermore, functional outcome scores after Biofiber-augmented repair were equal to or better than those recently reported for similar populations. Given this data, arthroscopic rotator cuff repair using a BioFiber augmented repair may provide a promising option in the treatment of patients with full-thickness rotator cuff tears.