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.
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.
Authors: Leonid I Katolik; Anthony A Romeo; Brian J Cole; Nikhil N Verma; Jennifer K Hayden; Bernard R Bach Journal: J Shoulder Elbow Surg Date: 2005 May-Jun Impact factor: 3.019
Authors: Struan H Coleman; Stephen Fealy; John R Ehteshami; John D MacGillivray; David W Altchek; Russell F Warren; A Simon Turner Journal: J Bone Joint Surg Am Date: 2003-12 Impact factor: 5.284
Authors: Bauke Kooistra; Navin Gurnani; Alexander Weening; Michel van den Bekerom; Derek van Deurzen Journal: Knee Surg Sports Traumatol Arthrosc Date: 2019-09-18 Impact factor: 4.342