Augmentation of a Transosseous-Equivalent Repair in Posterosuperior Nonacute Rotator Cuff Tears With a Bioinductive Collagen Implant Decreases the Retear Rate at 1 Year: A Randomized Controlled Trial.

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.

Instability severity index score values below 7 do not predict recurrence after arthroscopic Bankart repair.

PURPOSE: To evaluate the efficacy of the Instability Severity Index Score (ISIS) in predicting an increased recurrence risk after an arthroscopic Bankart repair. METHODS: Retrospective review of a cohort of patients operated in three different centres. The inclusion criteria (recurrent anterior instability [dislocation or subluxation] with or without hyperlaxity, arthroscopic Bankart repair) and the exclusion criteria (concomitant rotator cuff lesion, acute first-time dislocation, surgery after a previous anterior stabilization, surgery for an unstable shoulder without true dislocation or subluxation; multidirectional instability) were those used in the study that defined the ISIS score. The medical records and a telephone interview were used to identify the six variables that define the ISIS and identify recurrences. RESULTS: One hundred and sixty-three shoulders met the inclusion and exclusion criteria. Of these, 140 subjects (22 females/118 males; mean age 35.5 ± 7.9) with 142 (89.0%) shoulders were available for follow-up after 5.3 (1.1) (range 3.1-7.4) years. There were 20 recurrences (14.1%). The mean (SD) preoperative ISIS was 1.8 (1.6) in the patients without recurrence and 1.8 (1.9) in the patients with recurrence (n.s.). In the 117 subjects with ISIS between 0 and 3 the recurrence rate was 12.8%; in the 25 with ISIS 4 to 6 the rate was 20% (n.s.). CONCLUSION: For subjects with anterior shoulder instability in which an arthroscopic Bankart repair is being considered, the use of the ISIS, when the values obtained are ≤ 6 was not useful to predict an increased recurrence risk in the midterm in this retrospectively evaluated case series. The efficacy of the ISIS score in defining a group of subjects with a preoperative increased risk of recurrence after an arthroscopic Bankart instability repair is limited in lower risk populations (with ISIS scores ≤ 6). LEVEL OF EVIDENCE: Retrospective case series, Level IV.