Augmentation of a Transosseous-Equivalent Repair in Posterosuperior Nonacute Rotator Cuff Tears With a Bioinductive Collagen Implant Decreases the Retear Rate at One Year: A Randomized Controlled Trial

Miguel Ángel Ruiz Ibán; Miguel García Navlet; Santos Moros Marco; Jorge Diaz Heredia; Arántzazu Hernando Sánchez; Raquel Ruiz Díaz; Carlos Vaquero Comino; Maria Luisa Rosas Ojeda; Gabriel Del Monte Bello; Jose Luis Ávila Lafuente

doi:10.1016/j.arthro.2023.12.014

Augmentation of a Transosseous-Equivalent Repair in Posterosuperior Nonacute Rotator Cuff Tears With a Bioinductive Collagen Implant Decreases the Retear Rate at One Year: A Randomized Controlled Trial

Arthroscopy. 2023 Dec 28:S0749-8063(23)01018-6. doi: 10.1016/j.arthro.2023.12.014. Online ahead of print.

Affiliations

¹ Shoulder and Elbow Unit, Orthopaedic Surgery and Trauma Service, Hospital Universitario Ramón y Cajal, Madrid, Spain; Departamento de de Cirugía, Ciencias Sanitarias Y Medicosociales, Universidad de Alcalá de Henares, Alcalá de Henares, Madrid, Spain; Área De Traumatología y Ortopedia, Universidad CEU San Pablo, Madrid, Spain. Electronic address: drmri@hotmail.com.
² Shoulder and Elbow Unit, Orthopaedic Surgery and Trauma Service, Hospital Asepeyo Coslada, Madrid, Spain.
³ Shoulder and Elbow Unit, Orthopaedic Surgery and Trauma Service, Hospital Maz Zaragoza, Zaragoza, Spain.
⁴ Shoulder and Elbow Unit, Orthopaedic Surgery and Trauma Service, Hospital Universitario Ramón y Cajal, Madrid, Spain; Departamento de de Cirugía, Ciencias Sanitarias Y Medicosociales, Universidad de Alcalá de Henares, Alcalá de Henares, Madrid, Spain.
⁵ Shoulder and Elbow Unit, Orthopaedic Surgery and Trauma Service, Hospital Universitario Ramón y Cajal, Madrid, Spain.
⁶ Shoulder and Elbow Unit, Orthopaedic Surgery and Trauma Service, Hospital Fraternidad-Muprespa Habana, Madrid, Spain.

PMID: 38158165
DOI: 10.1016/j.arthro.2023.12.014

Abstract

Purpose: To determine whether the addition of a bioinductive collagen implant (BCI) over a transosseous equivalent (TOE) repair of medium-to-large posterosuperior rotator cuff tears improves the healing rate determined by magnetic resonance imaging (MRI) at 12-month follow-up.

Methods: A Level I randomized controlled trial was performed in 124 subjects with isolated, symptomatic, reparable, full-thickness, medium-to-large posterosuperior nonacute rotator cuff tears, with fatty infiltration ≤2. These were randomized to 2 groups in which an arthroscopic posterosuperior rotator cuff tear TOE repair was performed alone (Control group) or with BCI applied over the TOE repair (BCI group). The primary outcome was the retear rate (defined as Sugaya 4-5) determined by MRI at 12 months of follow-up. Secondary outcomes were characteristics of the tendon (Sugaya grade and thickness of the healed tendon) and clinical outcomes (pain levels, EQ-5D-5L, American Shoulder and Elbow Surgeons, and Constant-Murley scores) at 12 months of follow-up.

Results: Of the 124 randomized patients, 122 (60 in the BCI group and 62 in the Control group) were available for MRI evaluation 12.2 ± 1.02 months after the intervention. There were no relevant differences in preoperative characteristics. Adding the BCI reduced the retear rate (8.3% [5/60] in the BCI group vs 25.8% [16/62] in the Control group, P = .010; relative risk of retear of 0.32 [95% confidence interval 0.13-0.83]). Sugaya grade was also better in the BCI group (P = .030). There were no differences between groups in the percentage of subjects who reached the MCID for CMS (76.7% vs 81.7%, P = .654) or American Shoulder and Elbow Surgeons (75% vs 80%, P = .829), in other clinical outcomes or in complication rates at 12.4 ± 0.73 (range 11.5-17) months of follow-up.

Conclusions: Augmentation with a BCI of a TOE repair in a medium-to-large posterosuperior rotator cuff tear reduces the retear rate at 12-month follow-up by two-thirds, yielding similar improvements in clinical outcomes and without increased complication rates.

Level of evidence: Level I, randomized controlled trial.