title: A prospective, randomized evaluation of acellular human dermal matrix augmentation for arthroscopic rotator cuff repair.
abstract: OBJECTIVE
  To prospectively evaluate the safety and effectiveness of arthroscopic acellular human dermal matrix augmentation of large rotator cuff tear repairs.
  
  
  METHODS
  A prospective, institutional review board-approved, multicenter series of patients undergoing arthroscopic repair of 2-tendon rotator cuff tears measuring greater than 3 cm were randomized by sealed envelopes opened at the time of surgery to arthroscopic single-row rotator cuff repair with GraftJacket acellular human dermal matrix (Wright Medical Technology, Arlington, TN) augmentation (group 1) or without augmentation (group 2). Preoperative and postoperative functional outcome assessments were obtained by use of the American Shoulder and Elbow Surgeons (ASES), Constant, and University of California, Los Angeles scales. Gadolinium-enhanced magnetic resonance imaging (MRI) evaluation of these repairs was obtained at a mean of 14.5 months (range, 12 to 24 months). Adverse events were recorded.
  
  
  RESULTS
  There were 22 patients in group 1 and 20 in group 2 with a mean age of 56 years. The mean follow-up was 24 months (range, 12 to 38 months). The ASES score improved from 48.5 to 98.9 in group 1 and from 46.0 to 94.8 in group 2. The scores in group 1 were statistically better than those in group 2 (P = .035). The Constant score improved from 41.0 to 91.9 in group 1 and from 45.8 to 85.3 in group 2. The scores in group 1 were statistically better than those in group 2 (P = .008). The University of California, Los Angeles score improved from 13.3 to 28.2 in group 1 and from 15.9 to 28.3 in group 2 (P = .43). Gadolinium-enhanced MRI scans showed intact cuffs in 85% of repairs in group 1 and 40% in group 2 (P < .01). No adverse events were attributed to the presence of the matrix grafts.
  
  
  CONCLUSIONS
  Acellular human dermal matrix augmentation of large (>3 cm) cuff tears involving 2 tendons showed better ASES and Constant scores and more frequent intact cuffs as determined by gadolinium-enhanced MRI. Intact repairs were found in 85% of the augmented group and 40% of the nonaugmented group (P < .01). No adverse events related to the acellular human dermal matrix were observed.
  
  
  METHODS
  Level II, lesser-quality randomized controlled trial.
authors: Plano Orthopedic Sports Medicine and Spine Center, Plano, Texas 75093, USA.
authors: F Alan
authors: FA
authors: Barber
authors: Joseph P
authors: JP
authors: Burns
authors: Allen
authors: A
authors: Deutsch
authors: Marc R
authors: MR
authors: Labbé
authors: Robert B
authors: RB
authors: Litchfield
mesh_terms: D000328:Adult; D000368:Aged; D001182:Arthroscopy / Q000379:methods*; D005069:Evaluation Studies as Topic; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016059:Range of Motion, Articular / Q000502:physiology*; D020127:Recovery of Function; D012016:Reference Values; D017006:Rotator Cuff / Q000601:surgery*; D000070636:Rotator Cuff Injuries; D000070599:Shoulder Injuries; D017768:Skin, Artificial; D053441:Suture Anchors; D013708:Tendon Injuries / Q000175:diagnosis / Q000601:surgery; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing / Q000502:physiology