Early
INFLAMMATORY REACTION FOLLOWING Rotator Cuff Repair WITH a Porcine Small Intestine Submucosa Implant
Authors:
Hilary L. Malcarney MD, St. George Hospital, University of New South Wales, Sydney, Australia
George A.C. Murrell MBBS,
DPhil, St. George Hospital, University of New South
Wales, Sydney, Australia
Objective: To report an early, overt inflammatory reaction to a porcine small intestine submucosa implant used in rotator cuff repair.Methods: Twenty-five patients underwent open rotator cuff repair using the Restore Orthobiologic Implant (DePuy, Warsaw, Indiana, USA) from August, 2002 - February, 2003. The Restore Implant is an acellular, resorbable collagen scaffold. Derived from porcine small intestine submucosa, it is intended to strengthen soft tissue repair.Results: It is early to report functional outcomes of this patient group. However, four of the 25 patients experienced an overt inflammatory reaction at an average of seventeen days after initial rotator cuff repair using the Restore Orthobiologic Implant. All four patients were taken back to the operating room for irrigation and debridement. A large amount of yellow mucinous tissue was noted to communicate between the glenohumeral joint and the subacromial space. The Implant was not identifiable. Histopathological analysis noted inflamed granulation tissue. Blood work and cultures did not indicate infection.Conclusions: While the Restore Implant is an exciting development in soft tissue repair, our early clinical results suggest that it should be used with caution. Overt inflammation with apparent breakdown of the rotator cuff repair site was the result in four patients at approximately two weeks post-operatively. Our sample size of 25 patients is small, but with a complication rate of 16%, further investigation into the cause of this inflammatory reaction and repair failure is warranted.
