An isolated bioinductive repair vs. sutured repair for full-thickness rotator cuff tears: 2-year results of a double blinded, randomized controlled trial

Jorge Alberto Camacho Chacón; Victor Roda Rojo; Adrian Martin Martinez; Jorge Cuenca Espierrez; Veronica Garcia Calvo; José Manuel Calderón Meza; Carlos Martin Hernandez

doi:10.1016/j.jse.2024.03.043

An isolated bioinductive repair vs. sutured repair for full-thickness rotator cuff tears: 2-year results of a double blinded, randomized controlled trial

J Shoulder Elbow Surg. 2024 May 9:S1058-2746(24)00323-9. doi: 10.1016/j.jse.2024.03.043. Online ahead of print.

Authors

Jorge Alberto Camacho Chacón¹, Victor Roda Rojo², Adrian Martin Martinez², Jorge Cuenca Espierrez², Veronica Garcia Calvo³, José Manuel Calderón Meza⁴, Carlos Martin Hernandez³

Affiliations

¹ Instituto Aragones de Ortopedia, Traumatologia y Medicina Regenerative (IATR), C/ Los Andes 1 Bajo 2, 50012 Zaragoza, Spain. Electronic address: drjcamachoch@gmail.com.
² Instituto Aragones de Ortopedia, Traumatologia y Medicina Regenerative (IATR), C/ Los Andes 1 Bajo 2, 50012 Zaragoza, Spain.
³ Hospital Universitario Miguel Servet, IIS Aragon, Paseo Isabel la Catolica 1-3, 50009 Zaragoza, Spain.
⁴ Hospital Alcañiz, C. Repollés García, 2, 44600 Alcañiz, Teruel, Spain.

PMID: 38734130
DOI: 10.1016/j.jse.2024.03.043

Abstract

Background: Partial-thickness rotator cuff tears treated with an isolated bioinductive repair (IBR) in lieu of a completion-and-repair have shown complete healing. This treatment option is afforded by the remaining tendon's structural integrity, which is similar to that present in small/medium full-thickness tears (FTTs) when the rotator cable remains intact. This randomized controlled trial (RCT) investigated whether an IBR for small/medium FTTs resulted in superior healing and patient-reported outcomes (PROs) compared with a sutured repair.

Methods: This prospective, double blinded (patients and outcome assessors), single-center RCT enrolled patients ≥18 years with a small/medium (≤2.5cm) full thickness supraspinatus tear and intact rotator cable. Patients were randomized and blinded to arthroscopic transosseous-equivalent repair (control, n = 30) or IBR (n = 30). The primary outcome was tendon quality on biopsy at 6 months. Secondary outcomes were PROs (American Shoulder and Elbow Surgeons [ASES], Constant-Murley Shoulder [CMS], and pain visual analogue scale scores) and tendon thickness and healing measured via MRI at 6, 12, and 24 months; satisfaction at 12 and 24 months; and time to return to work.

Results: Baseline demographic, tear, and surgical characteristics were comparable between the groups (IBR: mean age, 54.2 years, 14 male; control: mean age, 56.4 years, 16 male). Measured via 6 month biopsy, highly organized, parallel bundles of collagen, without inflammation, were present in all IBR patients, whereas poorly organized, non-parallel collagen fibers were present in 24/30 (80%) of control patients (P < .0001), with 28/30 having minimal to mild inflammation. The increase in tendon thickness measured via MRI at 6 months from baseline was greater in the IBR group (2.0 mm) than in the control group (0.8 mm) (P < .0001). All IBR patients had 100% healing on MRI at 12 and 24 months. Compared with the control group, the IBR group had higher ASES and CMS scores at each evaluation, less pain at 6 and 12 months, and greater satisfaction at 12 and 24 months (P < .0003). The IBR group returned to work significantly faster (median 90 days [IQR, 25] vs. median 163.5 days [IQR, 24]; P < .0001) than the control group.

Conclusion: Compared with a sutured repair, the IBR treatment resulted in superior tendon quality, patient outcomes, satisfaction, and return to work. The IBR enabled a robust healing response evident through MRI and biopsy evaluation, demonstrating superior tendon quality and healing.

Keywords: augmented rotator cuff repair; bioinductive collagen implant; full-thickness rotator cuff tear; isolated bioinductive repair; rotator cable; rotator cuff; rotator cuff repair; rotator cuff tear.