Understanding preoperative health-related quality of life in rotator cuff tear patients: role of patients' characteristics.

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Abstract

[Indexed for MEDLINE] Conflict of interest statement: Declarations. Ethics approval and consent to participate: This project was carried out in accordance with the protocol and principles enunciated in the current version of the Declaration of Helsinki and guidelines of Good Clinical Practice (GCP) issued by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as well as Swiss law and Swiss regulatory authority requirements. Ethics approval was obtained on April 1st, 2020 from the lead ethics committee (Ethikkommission Nordwest- und Zentralschweiz (EKNZ), Basel, Switzerland; ID: 2019-02076) followed by subsequent amendments until December 20th, 2022, associated with the implementation of additional MRI examinations. All participants provided informed written consent before study enrollment . Consent for publication: Not applicable. Competing interests: The authors declare no competing interests. 20. Am J Sports Med. 2019 Jul;47(8):1901-1908. doi: 10.1177/0363546519850795. Epub 2019 May 31. Evaluation of Healing Rates and Safety With a Bioinductive Collagen Patch for Large and Massive Rotator Cuff Tears: 2-Year Safety and Clinical Outcomes. Thon SG(1), O'Malley L 2nd(2), O'Brien MJ(1), Savoie FH 3rd(1). Author information: (1)Tulane University, New Orleans, Louisiana, USA. (2)Mississippi Sports Medicine, Jackson, Mississippi, USA. 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. DOI: 10.1177/0363546519850795