Biologic augmentation fails to improve outcome in arthroscopic rotator cuff repair
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Biologic augmentation with platelet-rich fibrin matrix offered no benefits in healing or morbidity for patients undergoing arthroscopic rotator cuff repair in the first prospective, randomized study examining this issue.
Previous research had indicated potential improvements with platelet-rich fibrin matrix (PRFM), an important possibility given high rates of anatomic failure among patients undergoing arthroscopic rotator cuff repair. In fact, failure rates have approached 80% in some studies; prior to the current study, results of which were presented by Jeffrey I. Kauffman, MD,of Sacramento Knee and Sports Medicine in California, no randomized studies had been conducted looking into PRFMs potential.
Kauffman presented his study to the 2010 Annual Meeting of the American Orthopaedic Society for Sports Medicine.
No major differences
The investigators randomized 60 patients to either a PRFM group or a no PRFM group; those with prior surgery or open procedures were not included in the study, and those with clotting disorders or taking anticoagulant therapy also were excluded.
Postoperative rehabilitation did not differ between the groups, and assessments were made after 1, 3, 6 and 12 weeks. There were no complications in either group.
In spite of the suggestions from previous work that PRFM might provide some improvement in morbidity and healing, Visual Analog Scores (VAS) and postoperative use of narcotics did not differ significantly between the groups. There was a trend in VAS scores toward the non-PRFM group at 6 weeks, but it never reached significance.
Our operative time was about 10 minutes greater in the PRFM group, and this did reach statistical significance, Kauffman said. A large part of this was having to wait for the blood in the centrifuge.
Radiographs showed some residual defects in both groups, and patient age and size of the initial tear were both correlated with recurrent defects. Again, though, there was no difference in defects between the two groups.
Future directions
We hoped that postoperative pain would see a great benefit [with PRFM], Kauffman said. However, in this study, PRFM did not seem to be the answer. We saw no improvement in pain management, no improvement in clinical outcome.
He did add that with longer term follow-up significant differences could become apparent, but within the size and power of this study there is no evidence for benefit with PRFM.
There are few studies that support the use of these products, Kauffman added. They are expensive, and do have potential risks. It is our feeling that in this era of cost containment, PRFM should be limited to prospective, randomized, blinded studies to demonstrate clinical efficacy. by Dave Levitan
Reference:
Kauffman JI. Platelet-rich fibrin membrane in arthroscopic rotator cuff repair: A prospective, randomized study. Presented at the 2010 Annual Meeting of the American Orthopaedic Society for Sports Medicine. July 15-18. Providence, R.I.
Jeffrey I. Kauffman, MD, can be reached at 2801 K St., Suite 310, Sacramento, CA 95816; 916-454-6677. He receives an honorarium from Ferring Pharmaceuticals.
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