Evaluation of Healing Rates and Safety With a Bioinductive Collagen Patch for Large and Massive Rotator Cuff Tears: 2-Year Safety and Clinical Outcomes

Abstract

Background: Failure of repair of large and massive rotator cuff tears is a challenging problem within orthopaedics. Poor tendon tissue and vascularity are known causes for failure of rotator cuff repairs. Purpose: To assess the safety, outcomes, and healing rates when large and massive rotator cuff repairs are augmented with a bioinductive collagen scaffold patch in a proof-of-principle design. Study Design: Case series; Level of evidence, 4. Methods: Twenty-three patients undergoing repair of full-thickness large (2-tendon) or massive (3-tendon) rotator cuff tears augmented with a bioinductive collagen patch were enrolled in a prospective single-arm proof-of-principle study. No partial repairs were performed, and a complete rotator cuff repair was successfully achieved in each case. Sixteen patients underwent revision rotator cuff repairs versus 7 primary repairs. Safety was determined by any implant-related adverse event. A single magnetic resonance imaging (MRI) scan was utilized to confirm tendon healing and thickness at a minimum of 6 months postoperatively. Postoperative ultrasound (US) was used in office by the treating surgeon to assess tendon thickness at 3-, 6-, 12-, and 24-month intervals. American Shoulder and Elbow Surgeons (ASES) scores were collected at final follow-up. Results: Overall, a 96% (22 of 23) healing rate was confirmed on US and MRI. However, incidence of treatment clinical failure was 9% (2 of 23), as 1 patient’s tendon healed but eventually underwent additional surgery. There were no adverse events attributed to the implant reported. Final US rotator cuff thickness was 7.28 ± 0.85 mm (mean ± SD), and final MRI rotator cuff thickness was 5.13 ± 1.06 mm. The mean ASES score at final follow-up was 82.87 ± 16.68 (range, 53.33-100). Conclusion: No complications attributed to the implant were reported, and new tendon formation was apparent on US and MRI, with relatively high healing rates at 2-year follow-up. Arthroscopic application of this bioinductive collagen scaffold when combined with rotator cuff repair is a safe and effective treatment for healing of large and massive rotator cuff repairs.

Revision Hip Capsular Repair and Augmentation With a Bioinductive Implant After a Post-arthroscopy Hip Subluxation Event

“…Similarly, Bokor et al 10 and Schlegel et al 11 have shown promising results with this type of implant in partial rotator cuff tears, after arthroscopic subacromial decompression without repair of the tears, with magnetic resonance imaging showing new tissue formation, no tear progression, and improvements in PROM scores. More recently, Thon et al 12 reported a 96% healing rate, confirmed by ultrasound and magnetic resonance imaging, with no reported complications in patients undergoing large or massive rotator cuff tear repair augmented with this bioinductive implant.…”

Arthroscopic Hip Capsular Plication With Augmentation Using a Bioinductive Collagen Implant

“…These implants have a proven safety track record when used in the shoulder for rotator cuff disease and the benefit of increasing tissue thickness as a bioinductive scaffold has previously been demonstrated. 12 We feel its application within the hip provides a similar benefit in increasing the integrity of the capsular tissue in cases of microinstability. Future studies are needed to validate the increased tissue thickness and clinical outcomes of this technique.…”

“…Specifically, there have been no inflammatory reactions noted with their use. 11 , 12 Increased tissue thickness by as little as 2 mm has been shown to decrease intratendinous strain by as much as 47% in finite element analysis. 13 Given its proven safety and benefit of improving the biologic environment, we feel it has great potential in hip arthroscopy, particularly with capsule management by similarly increase capsular tissue thickness.…”

Recent advances and future trends in shoulder arthroscopy

“…[27] A 2-year follow-up of large and massive rotator cuff repairs that were augmented with a bioinductive collagen scaffold patch suggested 96% radiological healing rate and no adverse events attributed to the implant. [28] In a multicenter prospective study, use of a bioinductive collagen scaffold was found to be safe and effective for intermediate-to high-grade partial-thickness rotator cuff tears of the supraspinatus tendon. [29]…”