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

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 …