A Hyaluronic Acid-Based Patch for Use in Rotator Cuff Repair: Short-Term Clinical Exam-Based Outcomes

Background Rotator cuff tears are difficult to repair due to poor intrinsic healing ability and subsequent high retear rate. As such, patches have been developed to augment surgical repair and produce a local environment that is supportive of healing. While many have been clinically evaluated, the ideal patch has yet to be identified. Hyaluronic acid is ubiquitous in the musculoskeletal system and plays a significant role in the healing response through its cell signaling properties. The purpose of this study was to investigate the short-term clinical exam-based outcomes following rotator cuff repair utilizing a hyaluronic acid-based patch. Methods Twenty-nine patients with rotator cuff tears (mean age: 45.7 years - range 18-71 years; 14 male, 15 female) were treated with the Integrity™ Implant (Anika Therapeutics, Inc.). These patients were further divided into two subgroups by type of tear, i.e., partial tear (n=20) and full tear (n=9) which were statistically matched for gender (p = 0.782), BMI (p = 0.279), diabetic status (p = 0.124), and smoking status (p = 0.183) but with the full tear group (mean age 57.2 years) significantly older than the partial tear group (mean age 40.6 years) (p < 0.001). Thirteen partial tears were bursal side while 7 were articular side. Flexion, external rotation, VAS pain, and strength were evaluated at pre-op and at 3-month and 6-month post-op. Results Significant improvements in pain and function were obtained within 3-6 months. There were no significant differences in flexion, external rotation, or VAS pain between the partial and full tear groups from pre-op to 6 months. However, strength of the full tear group at pre-op and 3-month post-op was less than that of the partial tear group until reaching equivalence at 6 months. There was no clinical exam-based evidence of retear nor were any patch-related complications identified. Conclusions Rotator cuff repair utilizing augmentation with a hyaluronic acid-based patch demonstrated significant clinical improvement with no patch-associated complications or clinical evidence of retear. Furthermore, partial thickness and full thickness tear groups exhibited equivalent outcomes by 6 months. Longer term studies with MRI follow-up will further enhance understanding of the role of this patch in rotator cuff repair.