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

• Published in: European journal of orthopaedic surgery & traumatology 2013-04, Vol.23 (3), p.311-316
• Main Authors: Senekovic, Vladimir, Poberaj, Boris, Kovacic, Ladislav, Mikek, Martin, Adar, Eliyahu, Dekel, Assaf
• Format: Article
• Language: English
• Subjects: Absorbable Implants; Acromion - surgery; Aged; Aged, 80 and over; Arthroplasty, Replacement - methods; Female; Humans; Joint Prosthesis; Male; Medicine; Medicine & Public Health; Middle Aged; Original Article; Prospective Studies; Rotator cuff; Rotator Cuff Injuries; Shoulder Impingement Syndrome - etiology; Shoulder Impingement Syndrome - surgery; Shoulder Joint - surgery; Shoulder Pain - etiology; Shoulder Pain - surgery; Surgical Orthopedics; Traumatic Surgery
• ISSN: 1633-8065; 1432-1068
• DOI: 10.1007/s00590-012-0981-4

Purpose 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 3 years post-implantation. Methods Twenty patients were implanted with the InSpace™ device and assessed up to 3 years 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. Results Twenty patients were available for assessment. Implantation was performed arthroscopically in all patients, and a range of deployment time was 2–20 min. The mean total Constant score increased from 33.4 to 65.4 points at 3 years. There was an improvement of 6.4 points in subjective pain score which commenced at 1 week post-operatively and was sustained until 3 years 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 18 months of follow-up but was sustained at 3 years. Conclusions 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. Level of evidence IV; therapeutic case series