Interpositional scaffold anchor rotator cuff footprint tear repair: excellent survival, healing, and early outcomes.

Abstract

Shoulder function limitation duration after a full-thickness rotator cuff tendon (RCT) tear may influence post-repair healing and outcomes. A suture anchor was developed to improve footprint repair fixation and healing through biological fluid delivery and scaffold augmentation. The primary multicenter study objective was to evaluate RCT repair failure rate based on 6-month MRI examination, and device survival at 1-year follow-up. The secondary objective was to compare the clinical outcomes of subjects with shorter- and longer-term shoulder function limitation duration. Seventy-one subjects (46 men) with moderate-to-large RCT tears (1.5-4cm), at a median 61years of age (range = 40-76), participated in this study. Pre-repair RCT tear location/size and 6-month healing status were confirmed by an independent radiologist. Subjects with shorter- (Group 1: 17.8 ± 21days, n = 37) and longer-term (Group 2: 185.4 ± 89days, n = 34) shoulder function limitation durations were also compared over 1year for active mobility, strength, American Shoulder and Elbow Surgeon's Shoulder Score (ASES score), Veterans RAND 12 Item Health Survey (VR-12), and visual analog scale (VAS) pain and instability scores. Three of the 52 subjects [5.8%] who underwent 6-month MRI experienced a re-tear at the original RCT footprint repair site. By the 1-year follow-up, overall anchor survival was 97%. Although Group 2 displayed lower ASES and VR-12 scores pre-repair (ASES = 40.1 ± 17 vs. 47.9 ± 17; VR-12 physical health (PH) = 37.2 ± 9 vs. 41.4 ± 8) (p ≤ 0.048), at 3-month post-RCT repair (ASES = 61.3 ± 19 vs. 71.3 ± 20; VR-12 PH = 40.8 ± 8 vs. 46.8 ± 9) (p ≤ 0.038), and at 6-month post-RCT repair (ASES = 77.4 ± 18 vs. 87.8 ± 13; VR-12 PH = 48.9 ± 11 vs. 54.0 ± 9) (p ≤ 0.045), by 1-year post-RCT repair, groups did not differ (n.s.). Between-groups VR-12 mental health score differences were not evident at any time period (n.s.). Shoulder pain and instability VAS scores also did not differ (n.s.), displaying comparable improvement between groups from pre-RCT repair to 1-year post-RCT repair. Groups had comparable active shoulder mobility and strength recovery at each follow-up (n.s.). At 6-month post-RCT repair, only 3/52 of patients [5.8%] had a footprint re-tear, and at 1-year follow-up, overall anchor survival was 97%. Use of this scaffold anchor was associated with excellent early clinical outcomes regardless of shoulder function impairment duration. II.