Abstract
Objectives:
In our previous trial of 86 patients randomized to undergo rotator cuff repair with or without acromioplasty, no differences in functional and quality-of-life indices at 24-months post-operative were observed. At that time point, four patients (9%) in the group without acromioplasty required reoperation due to persistent symptoms (1 with a type-II acromion and 3 with type-III acromion) while no patients that underwent acromioplasty had follow-up surgery. This is consistent with other short-term studies; however, no long-term follow-up of a randomized clinical trial has been conducted. The aim of this study was to re-evaluate the patients from the original trial determine the long-term efficacy of performing a subacromial decompression in cases of full thickness rotator cuff tears.
Methods:
This is a secondary study based on a previous multi-centre, double-blind, balanced randomization (1:1), parallel-group study with patients allocated to arthroscopic rotator cuff repair with (ACR) or without acromioplasty (No ACR). Recruitment for the original study was conducted between June 2003 and February 2009 with 24-month follow-up taking place between 2005 and 2011. This secondary study was conducted between April 2015 and March 2021 with all patients randomized in the main study comprising the study sample. Additional exclusion criteria were those who were unable or unwilling to provide informed consent. Patients from the original study were invited by a blinded assessor to return for a follow-up visit involving the same methodology as their previous visits. The visit included completion of a patient-reported outcome, the Western Ontario Rotator Cuff score (WORC) and clinical assessment. If a participant was unable to return for a clinical evaluation, they were asked to complete the WORC by mail.
Results:
Eighty-six patients were randomized in the original trial. Fifty-seven of those completed the long-term follow-up, 31 of 45 from the No ACR group and 25 of 41 from the ACR group. Sixty-one percent in the No ACR group and 64% in the ACR group were male. The mean (SD) duration of follow-up was 11.2 (2.4) years for No ACR and 11.5 (2.6) years for ACR, respectively. Mean (SD) age of patients at the time of initial surgery for the No ACR group was 58.5 (8.4) and for the ACR group was 56.2 (7.8), while mean age at the most recent follow-up was 69.0 (9.3) for No ACR and 67.7 (7.7) for ACR. Mean (SD) WORC scores at pre-operative, 24-months and long-term follow-up are presented by group in Table 1. There was no significant difference in WORC between the No ACR and ACR groups at the time of long-term follow-up (p=0.30). WORC score maintained a significant improvement from pre-operative scores in both groups (p < 0.001). In the initial study at 24-months post-operative, four patients were identified in the No ACR group who underwent revision surgery. Of those, 2 returned for long-term follow-up and 2 did not. In long term follow-up, another 6 patients were identified that underwent additional surgery on their study shoulder since the 24-month follow-up, including 3 rotator cuff revisions, 1 total shoulder arthroplasty, and 2 unknown shoulder surgeries (patient-reported). Therefore, 10 (22%) of the 45 patients in the No ACR group underwent further shoulder surgery. One participant, 2% of the initial 41 patients allocated to ACR, underwent a revision shoulder surgery.
Conclusions:
The main finding of this study was that at long-term (mean 11 years post-operative) follow-up of patients randomized to undergo rotator cuff repair with or without acromioplasty, there was no difference in patient-reported outcome, specifically WORC scores. Both groups maintained improved outcomes from their pre-operative status. However, revision rate was significantly higher in those that did not undergo acromioplasty at the time of their initial surgery.
Patient flow through study.
WORC scores over time by group.