MRI and Patient Reported Outcomes of a Hyaluronic Acid Based Rotator Cuff Augmentation Implant: A Pilot Case Series

Aims & Objectives Recent literature has focused on improving rotator cuff repair (RCR) healing rates by using “patches” of various properties. The purpose was to report on safety, efficacy, MRI imaging results, and patient reported outcome measures (PROMs) at 3 and 6 months for an FDA cleared Hyaluronic Acid (HA) based “patch” system. Materials & Methods A case series of 10 patients who underwent implantation with the HA patch for either full thickness tears (FT-RTC) or partial thickness tears (PT-RTC). Preoperative and postoperative PROMs including ASES, SANE, and PROMIS scores were collected. MRIs were compared between preop and postop at 3 months and 6 months. Results 10 patients were included: 4 underwent purely “onlay” repair for PT-RTC tear and 6 underwent “augmentation” after completion of FT-RTC repairs with the HA patch. Overall, patients had statistically significant improvements in SANE scores at 3 and 6 months postop (p=0.013 and p<0.001), ASES at 6 months (p<0.001), and PROMIS Physical at 6 months (p=0.004). Tendon thickness significantly increased from 4.77 ± 0.67 mm to 7.63 ± 1.30 mm and 7.61 ± 1.03 mm at 3 and 6 months, respectively (p<0.001). There was abundant subacromial healing response and a thickened layer of tendon-like tissue where the HA patch was placed at 3 months postop, with tissue appearing more organized and incorporated into the tendon at 6 months. There were no recurrent tears or complications. Conclusions This series demonstrates safety and efficacy when managing both PT-RTC and FT-RTC tears with an HA based patch. Keywords: Augmentation, Hyaluronic Acid, Patch, Rotator Cuff, Shoulder Level of Evidence IV, Case Series