Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears

Abstract

The purposes of this prospective non-randomized study were to confirm the feasibility of the biodegradable sub-acromial spacer (InSpace™) implantation in patients with massive irreparable rotator cuff tear and to determine the safety profile and functional results 3years post-implantation. Twenty patients were implanted with the InSpace™ device and assessed up to 3years of post-implantation. Improvement in shoulder function was assessed using Constant score, while ease of use of the system was recorded by surgeons as were device-related adverse events. Twenty patients were available for assessment. Implantation was performed arthroscopically in all patients, and a range of deployment time was 2-20min. The mean total Constant score increased from 33.4 to 65.4 points at 3years. There was an improvement of 6.4 points in subjective pain score which commenced at 1week post-operatively and was sustained until 3years of follow-up. Also activities of daily living and motions commenced improvement by 9.4 and 7.7 points, respectively. Improvement in power was only evident at 18months of follow-up but was sustained at 3years. Arthroscopic deployment of a co-polymer biodegradable spacer (balloon) into the sub-acromial space for an irreparable rotator cuff tear was found to be low-risk and simple procedure associated with improvement in shoulder function and low rate of complications. IV; therapeutic case series.