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Restore Orthobiologic Implant: Not Recommended for Augmentation of Rotator Cuff Repairs
Judie R. Walton, PhD1; Nicholas K. Bowman, MBBS1; Yasser Khatib, MBBS1; James Linklater, MBBS2; George A.C. Murrell, MD, DPhil1
1 Orthopaedic Research Institute, Research and Education Centre, Level 2, 4-10 South Street, Sydney (Kogarah) NSW 2217, Australia. E-mail address for G.A.C. Murrell: admin@ori.org.au
2 Castlereagh Imaging, Crows Nest NSW, Australia
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Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.
Investigation performed at the Sports Medicine and Shoulder Service, Orthopaedic Research Institute, University of New South Wales, St. George Hospital, Sydney (Kogarah), New South Wales, Australia

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2007 Apr 01;89(4):786-791. doi: 10.2106/JBJS.F.00315
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Background: Following repairs of large-to-massive tears of the rotator cuff, the rates of tendon retears are high and often involve tissue deficiency. Animal studies of the Restore Orthobiologic Implant, a collagen-based material derived from the small intestine mucosa of pigs, have indicated that it might be used to help overcome such problems. We carried out a study to determine whether patients who received this xenograft to augment a rotator cuff repair exhibited greater shoulder strength, shoulder function, and/or resistance to retearing.

Methods: We compared data from a group of patients who had undergone conventional rotator cuff repair with xenograft augmentation (the xenograft group) with data from a group in whom a repair had been done by the same surgeon without augmentation (the controls). The groups were matched for gender, mean age, and mean size of the rotator cuff tear. All subjects completed a pain and function questionnaire and were given a systematic clinical shoulder examination preoperatively and at three, six, and twenty-four months postoperatively. The twenty-four-month visit included magnetic resonance imaging to determine whether a retear had occurred.

Results: Four patients who had received a xenograft had a severe postoperative reaction requiring surgical treatment. At two years after the surgery, six of the ten tendons repaired with a xenograft and seven of the twelve control tendons had retorn, as documented by magnetic resonance imaging. The patients with a xenograft had significantly less lift-off strength, as measured with a dynamometer, and significantly less strength in internal rotation and adduction than the controls at two years after the surgery (all p < 0.05). Also, the xenograft group had significantly more impingement in external rotation, a slower rate of resolution of pain during activities, more difficulty with hand-behind-the-back activities, and less sports participation (all p < 0.05).

Conclusions: Two years after surgical repair of a large rotator cuff defect supplemented with a xenograft, patients had several persisting deficits and no recognizable benefit as compared with the results in a control group. In view of these findings, together with the unsatisfactorily high proportion of patients with a severe inflammatory reaction to the xenograft, we do not recommend use of the Restore Orthobiologic Implant in its present form.

Level of Evidence: Therapeutic Level III. See Instructions to Authors for a complete description of levels of evidence.

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    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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