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

62 patients with a rotator cuff tear were randomized to either augmented open repair with a porcine small intestine submucosa (SIS) graft or non-augmented open repair. The purpose of this pilot study was to evaluate if the SIS graft significantly reduced the incidence of retear over the first year of follow-up. Results demonstrated a non-significant difference between groups in the incidence of retear. Additionally, no significant differences in functional outcome measures were observed either.