title: Fluoroscopy-guided biodegradable spacer implantation using local anesthesia: safety and efficacy study in patients with massive rotator cuff tears.
abstract: BACKGROUND
  The management of massive rotator cuff tears (MRCTs) is challenging and associated with a high failure rates. Studies have shown that advanced age, lower American Society of Anesthesiologists physical status score and concomitant comorbidities are associated with higher risks of death and postoperative complications. This study was designed to assess the safety and efficacy of fluoroscopy-guided biodegradable spacer implantation under local anesthesia, in patients with MRCT and comorbidities completely or partially contraindicating surgeries under general anesthesia.
  
  
  METHODS
  In this open-label, single arm, prospective study, subjects with MRCTs underwent subacromial fluoroscopy-guided implantation with a biodegradable spacer (InSpace™ system) under local anesthesia. Fifteen patients were treated and assessed. Follow-up visits were scheduled according to routine clinical practice. Shoulder function was evaluated using Constant (CS) and American Shoulder and Elbow Society (ASES) scores.
  
  
  RESULTS
  All patients demonstrated an overall improvement in the total CS and ASES beginning at 6 weeks and sustained by at least 12 months postoperatively. Of the 15 patients who reached the 1-year follow-up, 85% showed a clinically significant improvement of at least 15 points in their Constant score starting at 6 weeks postoperation and maintained throughout the entire follow-up period.
  
  
  CONCLUSIONS
  We conclude that in this initial patient's cohort, fluoroscopy-guided implantation of InSpace™ system under local anesthesia, represented an effective alternative to the existing procedures. This procedure may be considered as a treatment option for elderly patients or for patients with multiple comorbidities complicating or contraindicating surgery under general anesthesia. Technically easy, this technique can be an effective tool in the armamentarium of most orthopedic surgeons. Level of proof: single-arm prospective study, Level II.
authors.affiliation: Department of Orthopedic Surgery, Latisana Civil Hospital, Via Sabbionera 45, Latisana, 33053, Udine, Italy. gervasi.enrico@libero.it.
authors.forename: E
authors.initials: E
authors.lastname: Gervasi
authors.affiliation: Shoulder Unit, Division of Orthopaedic Surgery, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
authors.forename: E
authors.initials: E
authors.lastname: Maman
authors.affiliation: Advanced Orthopedic Clinic, Assuta Medical Center, Tel Aviv, Israel.
authors.forename: A
authors.initials: A
authors.lastname: Dekel
authors.affiliation: Department of Orthopedic Surgery, Latisana Civil Hospital, Via Sabbionera 45, Latisana, 33053, Udine, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Cautero
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000772:Anesthesia, Local / Q000379:methods; D003646:Debridement / Q000379:methods; D005260:Female; D005471:Fluoroscopy / Q000379:methods; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D019637:Orthopedic Procedures / Q000379:methods*; D061214:Patient Safety; D011446:Prospective Studies; D016059:Range of Motion, Articular; D000070636:Rotator Cuff Injuries / Q000000981:diagnostic imaging* / Q000601:surgery* / Q000628:therapy; D016037:Single-Blind Method; D013710:Tendons / Q000637:transplantation*; D016896:Treatment Outcome
keywords: Biodegradable spacer; Fluoroscopy-guided subacromial implantation; Local anesthesia; Massive rotator cuff tears