Arthroscopic rotator cuff repair has led to a high rate of patient satisfaction with clinical outcomes equivalent to open repair at long-term follow-up. Multiple studies however have shown high rates of anatomic failure, approaching 80% in some studies. Techniques such as double-row repair have not been shown to dramatically decrease the rate of anatomic failure in comparative studies. Biological augmentation would seem to be a reasonable technique to improve healing rates. Early, anecdotal studies have suggested both improved healing rates and improvement in perioperative morbidity with platelet-rich fibrin matrix (PRFM). This study represents the first prospective, randomized study to assess these claims.
The study design was approved by institutional review board. Pre-study power assessment suggested that a sample size of 30 patients in each group would allow detection of a 20% difference in perioperative pain scores. After appropriate informed consent, patients were randomized to arthroscopic treatment either with or without PRFM. All patients had arthroscopic rotator cuff repair performed under general anesthesia using standard suture-anchor technique. Those patients randomized to PRFM had the arthroscopic application of PRFM at the conclusion of the repair as described by Anderson. Post operative rehabilitation was identical between groups. Patients were assessed at one, three, six weeks and three months postoperatively. Serial VAS scores were obtained, as well as SST scores at each interval. Final scores for each group included UCLA and ASES scores.
No complications occurred in either group. All patients had surgery performed as an outpatient procedure without incidence. VAS scores and post operative narcotic use did not differ significantly between the two groups. Serial SST and VAS scores showed a trend at six weeks towards the non-PRFM augmented group, but there was no significant difference at any time between the two groups. Preliminary review of post operative radiographs showed residual defects in both groups; recurrent defects were correlated with patient age (r=0.88) and size of tear (0.72) but differences in residual defects in the treated and untreated groups were not significantly different.
Within the power of this study, PRFM was not shown to significantly improve perioperative morbidity. Early clinical results were similar between the two groups. While longer-term follow-up may show differences, early follow-up does not show significant improvement in structural integrity.
© 2010 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.