Objective
The main purpose of our study was to assess whether the use of leukocyte-poor platelet rich plasma (LP-PRP) as an adjuvant to ARCRs decreases the rate of retears compared to a control group. The secondary objective of our study was to analyze whether LP-PRP improves the patient-reported outcomes (PROMs).
Methods
This was a a double-blind randomized controlled trial at a single center. A consecutive series of 96 patients with rotator cuff tears < 3 cm were enrolled and randomly allocated to a control group (double-row suture-bridge ARCR alone, n = 48) and a study group (double-row suture-bridge repair followed by one LP-PRP injections at the tendon repair site during surgery, n= 48). The visual analog scale (VAS) for pain, the American Shoulder and Elbow Surgeons (ASES) score, the Single Assessment Numeric Evaluation (SANE) and The Pittsburgh Sleep Quality Index were evaluated preoperatively and at 6 and 12 month follow up. An MRI examination was performed to evaluate tendon integrity at 6 months follow up according to the Sugaya classification. Both, patients and assessors were blinded to the intervention received during surgery.
Results
The mean age was 56.1 (±2.98). Of the 96 patients, 90 had MRI performed at 6 months after surgery (94% radiological follow-up). The retear rate in PRP group was 15.2% (7/46) [CI 95% 6%-28%] which was lower than that in the control group (34.1%, (15/44) [CI 95% 20%-49%], P = .037. Therefore, the Risk Ratio of rupture in patients exposed to PRP was 0.44 (CI 95% 0.2 - 0.9; p = 0.037). Overall, the ASES, VAS, SANE and Pittsburgh scores showed statistical improvement after the operation (P < .01). There were no significant differences in functional scores between the groups at any of the postoperative follow-up times. Most of the patients exceeded the MCID for the ASES, SANE and VAS scores without significant differences between the groups.
Conclusion
In patients with RCTs < 3 cm undergoing double-row suture-bridge repair, a 5-mL dose of LP- PRP placed at the tendon-bone interface at the time of surgery can significantly reduce the postoperative retear rate. However, the use of LR-PRP in terms of postoperative pain and patient reported outcomes failed to show clinically meaningful effects.