Favorable Early Patient-Reported Outcome Measures and Clinical Retear Rates in High-Risk Rotator Cuff Repairs Augmented with a Reinforced Bio-Inductive Implant at One-Year Follow Up.

Abstract

Introduction: The purpose of this article is to examine the risk of early clinical rotator cuff repair failures in high-risk patients who were augmented with a reinforced bio-inductive implant (RBI).

Materials and methods: A retrospective chart review was performed identifying full-thickness rotator cuff repairs (RCR) augmented with an RBI. Inclusion criteria for "high risk of retear" were: large (>3cm) and massive (>5cm, >/= 2 tendons) tears, anterior to posterior (AP) tear >2.5cm, infraspinatus fatty atrophy (Goutalier >/= 2), recurrent tears, and at least one comorbidity (diabetes, hypertension, active smoker). ROM, VAS, and ASES scores were collected at preoperative, three-month, six-month, and 12-month visits. Clinical failures were defined as complete retear based upon imaging, repeat rotator cuff surgery, VAS score >5 at one-year postoperative, and ASES MCID <27-point improvement.

Results: Forty-nine patients were found to have undergone RCR with an RBI augmentation. Mean follow up was 26.1 months. Clinical healing rate was 94% (46/49). The need for surgical intervention post RCR was 8.2% (4/49). The complication rate was 14.3% (7/49). VAS scores at three, six, and 12 months compared to preop revealed statistically significant decreases at all timepoints (D-3.9, D-4.6, D-5.2, respectively, p<0.001). ASES scores at three, six, and 12 months compared to pre-surgical scores met the MCID and were found to have statistically significant improvements at all timepoints (D30.7, D40.8, D49.8, respectively, p<0.001). Shoulder ROM (forward flexion/abduction) at three, six, and 12 months compared to preop was found to be statistically significant at all timepoints (p<0.01).

Conclusion: The addition of an RBI to RCR in patients at high risk of failure demonstrated favorable outcomes in terms of range of motion, pain, and functional outcome scores with a low rate of clinical retear at a minimum of one-year follow up.

Clinical relevance: Many risk factors have been attributed to high retear rates and poor clinical outcomes in patients undergoing RCR. Numerous variations to RCR have been explored to aid in outcomes and decrease failures. This manuscript is the first to examine the use of an RBI as an RCR augment. The implant's bio-inductive properties and strength profile demonstrate promising benefits at early timepoints in this study, indicating that it can improve patient-reported outcomes while decreasing clinical failures in patients at high risk of retear.