title: Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  IV; therapeutic case series.
authors: Department of Traumatology, University Medical Centre Ljubljana, Zaloska 2, Ljubljana, Slovenia.
authors: Vladimir
authors: V
authors: Senekovic
authors: Boris
authors: B
authors: Poberaj
authors: Ladislav
authors: L
authors: Kovacic
authors: Martin
authors: M
authors: Mikek
authors: Eliyahu
authors: E
authors: Adar
authors: Assaf
authors: A
authors: Dekel
mesh_terms: D020341:Absorbable Implants; D000174:Acromion / Q000601:surgery*; D000368:Aged; D000369:Aged, 80 and over; D019643:Arthroplasty, Replacement / Q000379:methods; D005260:Female; D006801:Humans; D007595:Joint Prosthesis; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000070636:Rotator Cuff Injuries; D019534:Shoulder Impingement Syndrome / Q000209:etiology / Q000601:surgery*; D012785:Shoulder Joint / Q000601:surgery; D020069:Shoulder Pain / Q000209:etiology / Q000601:surgery