title: Rotator cuff repair augmentation using a novel polycarbonate polyurethane patch: preliminary results at 12 months' follow-up.
abstract: BACKGROUND
  Preventing anatomic failure after rotator cuff repair (RCR) remains a challenge. Augmentation with a surgical mesh may permanently reinforce the repair and decrease failure rates. The purpose of this study is to assess the postoperative outcomes of open RCR augmented with a novel reticulated polycarbonate polyurethane patch.
  
  
  METHODS
  Ten patients with supraspinatus tendon tears underwent open RCR augmented with a polycarbonate polyurethane patch secured in a 6-point fixation construct placed over the repaired tendon. Patients were evaluated with preoperative and postoperative outcome measures, including the Simple Shoulder Test, visual analog pain scale, American Shoulder and Elbow Surgeons shoulder score, Cumulative Activities of Daily Living score, and University of California, Los Angeles shoulder scale, as well as range of motion. Postoperative magnetic resonance imaging was used to evaluate repair status.
  
  
  RESULTS
  Patients showed significant improvements in visual analog pain scale, Simple Shoulder Test, and American Shoulder and Elbow Surgeons shoulder scores at both 6 and 12 months postoperatively (P < .05 and P < .01, respectively). The University of California, Los Angeles postoperative score was good to excellent in 7 patients at 6 months and in 8 patients at 12 months. Range of motion in forward flexion, abduction, internal rotation, and external rotation was significantly improved at both 6 and 12 months postoperatively (P < .05 and P < .01, respectively). Magnetic resonance imaging at 12 months showed healing in 90%; one patient had a definitive persistent tear. We found no adverse events associated with the patch, including the absence of fibrosis, mechanical symptoms, or visible subacromial adhesions.
  
  
  CONCLUSIONS
  The polycarbonate polyurethane patch was designed to support tissue in growth and enhance healing as shown by preclinical animal studies. Clinically, the patch is well tolerated and shows promising efficacy, with a 10% retear rate at the 12-month time point.
authors.affiliation: Shoulder and Elbow Department, National Institute for Rehabilitation, Mexico City, Mexico.
authors.forename: Ivan
authors.initials: I
authors.lastname: Encalada-Diaz
authors.forename: Brian J
authors.initials: BJ
authors.lastname: Cole
authors.forename: John D
authors.initials: JD
authors.lastname: Macgillivray
authors.forename: Michell
authors.initials: M
authors.lastname: Ruiz-Suarez
authors.forename: James S
authors.initials: JS
authors.lastname: Kercher
authors.forename: Nicole A
authors.initials: NA
authors.lastname: Friel
authors.forename: Fernando
authors.initials: F
authors.lastname: Valero-Gonzalez
mesh_terms: D000328:Adult; D000368:Aged; D001182:Arthroscopy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D011076:Polycarboxylate Cement; D011140:Polyurethanes; D016059:Range of Motion, Articular; D019651:Plastic Surgery Procedures / Q000379:methods*; D017006:Rotator Cuff / Q000601:surgery*; D000070636:Rotator Cuff Injuries; D012421:Rupture; D012782:Shoulder / Q000601:surgery; D000070599:Shoulder Injuries; D013536:Suture Techniques / Q000295:instrumentation*; D013708:Tendon Injuries / Q000503:physiopathology / Q000601:surgery*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D011076:Polycarboxylate Cement; D011140:Polyurethanes; C005506:polycarbonate