The biodegradable spacer as a novel treatment modality for massive rotator cuff tears: a prospective study with 5-year follow-up.

Background: The management of massive, irreparable rotator cuff tears (RCT) is challenging and associated with high failure rates. There are no current consensus or definitive guidelines concerning the optimal surgical treatment for this devastating condition. This study was designed to confirm the long-term safety and efficacy of the biodegradable inflatable InSpace™ system in patients with massive reparable or irreparable RCTs.

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

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.