title: A randomized clinical trial to compare the effectiveness of rotator cuff repair with or without augmentation using porcine small intestine submucosa for patients with moderate to large rotator cuff tears: a pilot study.
abstract: BACKGROUND
  The rate of rotator cuff repair failure is between 13% and 67%. Porcine small intestine submucosa (SIS) may be suitable to augment the repair.
  
  
  METHODS
  There were 62 patients with moderate and large cuff tears randomized to repair alone (control) or augmentation with SIS (Restore Orthobiologic Implant; DePuy, Warsaw, IN, USA). Primary outcome was repair failure using magnetic resonance arthrography. Randomization occurred on completion of the repair. Patients and assessors were blind to group. Assessments occurred preoperatively and postoperatively at 2 and 6 weeks and 3, 6, 12, and 24 months.
  
  
  RESULTS
  There were 62 patients randomized (34 SIS, 28 control). Patient demographics, rotator cuff tear characteristics, and repair details were similar between groups. At 1 year, risk of failure was 52.9% (18/34) in the SIS group and 65.4% (17/26) in the control group for a risk difference of 12% (80% confidence interval, -7% to 32%) or relative risk of 0.81 (95% confidence interval, 0.53-1.24, P = .33) in favor of SIS. At 1 and 2 years, the mean difference between groups for patient-reported outcomes was small and consistent with chance but did not exclude the possibility of a clinically important difference. There was no statistically significant difference (P = .50) between the SIS group (59.6 ± 38.9; range, 3-112) and the control group (52.7 ± 38.6; range, 5-112) in number of days to being narcotic and pain free (<20 mm on a 100-mm visual analog scale).
  
  
  CONCLUSIONS
  We found no evidence that SIS-augmented rotator cuff repair provides superior outcomes in patients with moderate rotator cuff tears.
authors.affiliation: Western University, London, ON, Canada; McMaster University, Hamilton, ON, Canada.
authors.forename: Dianne
authors.initials: D
authors.lastname: Bryant
authors.affiliation: University of Toronto, Toronto, ON, Canada.
authors.forename: Richard
authors.initials: R
authors.lastname: Holtby
authors.affiliation: Western University, London, ON, Canada. Electronic address: kwillit@uwo.ca.
authors.forename: Kevin
authors.initials: K
authors.lastname: Willits
authors.affiliation: Western University, London, ON, Canada.
authors.forename: Robert
authors.initials: R
authors.lastname: Litchfield
authors.affiliation: Western University, London, ON, Canada.
authors.forename: Darren
authors.initials: D
authors.lastname: Drosdowech
authors.affiliation: Western University, London, ON, Canada.
authors.forename: Alison
authors.initials: A
authors.lastname: Spouge
authors.affiliation: Western University, London, ON, Canada.
authors.forename: David
authors.initials: D
authors.lastname: White
authors.affiliation: McMaster University, Hamilton, ON, Canada.
authors.forename: Gordon
authors.initials: G
authors.lastname: Guyatt
mesh_terms: D000328:Adult; D000368:Aged; D000818:Animals; D019643:Arthroplasty, Replacement / Q000379:methods; D001705:Bioprosthesis; D005260:Female; D006801:Humans; D015601:Injury Severity Score; D007413:Intestinal Mucosa; D008297:Male; D008875:Middle Aged; D009864:Ontario; D010147:Pain Measurement; D010865:Pilot Projects; D020127:Recovery of Function; D000070636:Rotator Cuff Injuries / Q000473:pathology / Q000601:surgery*; D013552:Swine; D016896:Treatment Outcome
keywords: MRI; Rotator cuff repair; augmentation; patient-reported outcomes; porcine intestine submucosa; randomized clinical trial; restore; shoulder