title: Outcome of Large to Massive Rotator Cuff Tears Repaired With and Without Extracellular Matrix Augmentation: A Prospective Comparative Study.
abstract: OBJECTIVE
  To compare the results of arthroscopic repair of large to massive rotator cuff tears (RCTs) with or without augmentation using an extracellular matrix (ECM) graft and to present ECM graft augmentation as a valuable surgical alternative used for biomechanical reinforcement in any RCT repair.
  
  
  METHODS
  We performed a prospective, blinded, single-center, comparative study of patients who underwent arthroscopic repair of a large to massive RCT with or without augmentation with ECM graft. The primary outcome was assessed by the presence or absence of a retear of the previously repaired rotator cuff, as noted on ultrasound examination. The secondary outcomes were patient satisfaction evaluated preoperatively and postoperatively using the 12-item Short Form Health Survey, the American Shoulder and Elbow Surgeons shoulder outcome score, a visual analog scale score, the Western Ontario Rotator Cuff index, and a shoulder activity level survey.
  
  
  RESULTS
  We enrolled 35 patients in the study: 20 in the ECM-augmented rotator cuff repair group and 15 in the control group. The follow-up period ranged from 22 to 26 months, with a mean of 24.9 months. There was a significant difference between the groups in terms of the incidence of retears: 26% (4 retears) in the control group and 10% (2 retears) in the ECM graft group (P = .0483). The mean pain level decreased from 6.9 to 4.1 in the control group and from 6.8 to 0.9 in the ECM graft group (P = .024). The American Shoulder and Elbow Surgeons score improved from 62.1 to 72.6 points in the control group and from 63.8 to 88.9 points (P = .02) in the treatment group. The mean Short Form 12 scores improved in the 2 groups, with a statistically significant difference favoring graft augmentation (P = .031), and correspondingly, the Western Ontario Rotator Cuff index scores improved in both arms, favoring the treatment group (P = .0412).
  
  
  CONCLUSIONS
  The use of ECM for augmentation of arthroscopic repairs of large to massive RCTs reduces the incidence of retears, improves patient outcome scores, and is a viable option during complicated cases in which a significant failure rate is anticipated.
  
  
  METHODS
  Level III, prospective, blinded, nonrandomized, comparative study.
authors.affiliation: Department of Orthopaedic Surgery, Cleveland Clinic Florida, Weston, Florida, U.S.A.
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Gilot
authors.affiliation: Department of Orthopaedic Surgery, Cleveland Clinic Florida, Weston, Florida, U.S.A.. Electronic address: mauricioalvarez07@yahoo.com.
authors.forename: Andres M
authors.initials: AM
authors.lastname: Alvarez-Pinzon
authors.affiliation: Department of Orthopaedic Surgery, Cleveland Clinic Florida, Weston, Florida, U.S.A.
authors.forename: Leticia
authors.initials: L
authors.lastname: Barcksdale
authors.affiliation: Department of Orthopaedic Surgery, Cleveland Clinic Florida, Weston, Florida, U.S.A.
authors.forename: David
authors.initials: D
authors.lastname: Westerdahl
authors.affiliation: Department of Orthopaedic Surgery, Cleveland Clinic Florida, Weston, Florida, U.S.A.
authors.forename: Michael
authors.initials: M
authors.lastname: Krill
authors.affiliation: Department of Orthopaedic Surgery, Cleveland Clinic Florida, Weston, Florida, U.S.A.
authors.forename: Evan
authors.initials: E
authors.lastname: Peck
mesh_terms: D000368:Aged; D001178:Arthroplasty / Q000379:methods*; D001182:Arthroscopy / Q000379:methods*; D005109:Extracellular Matrix / Q000637:transplantation*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D012008:Recurrence; D017006:Rotator Cuff / Q000601:surgery*; D000070636:Rotator Cuff Injuries; D012785:Shoulder Joint / Q000601:surgery*; D016037:Single-Blind Method; D013710:Tendons / Q000601:surgery; D015599:Trauma Severity Indices; D016896:Treatment Outcome