Platelet-rich fibrin in arthroscopic repair of massive rotator cuff tears: a prospective randomized pilot clinical trial.

The objective of this study was to prospectively evaluate the feasibility of a large- scale project on the influence of local application of Platelet Rich Fibrin (PRF) on the functional outcome and integrity of the arthroscopically repaired tendons in patients with massive tears of the rotator cuff. A prospective, randomized pilot clinical trial was performed on 28 patients (22 females, 6 males) with an average age of 65 years (range: 53 to 77) undergoing complete arthroscopic repair of a massive rotator cuff tear. After the repair was completed, 6 ml PRF (Vivostat) was locally applied to the repair site in 14 patients; no similar action was done in the other 14 patients. All patients underwent a clinical examination and an arthro-MRI to evaluate the integrity of the repair, one year after the operation. They were followed clinically for a minimum of 2 years. Functional outcome was evaluated with the Constant and DASH scores. There were no reported complications in either group. None of the patients was lost to follow-up. Globally, the Constant score improved from 45 preoperatively (range: 25 to 65) to 64 at one year (range: 20 to 79) (p < 0.001), with no significant change at two years (mean 63, range: 20 to 77). The VAS for pain improved from 5.6/10 preoperatively to 1.7/10 at the most recent examination (p < 0.001). All but two patients were satisfied. With the numbers of patients available, we could not detect a significant difference in the preoperative (46 vs. 43; p = 037) or postoperative Constant score (61 vs. 68; p = 0.125) between the control group and the PRF group. On arthro-MRI, 19 of the 28 patients (68%) were found to have a large re-tear : 10/14 in the PRF group and 9/14 in the control group. Local application of autologous PRF to the repair site of massive rotator cuffs fully reconstructed arthroscopically failed to improve the clinical outcome and the healing rate, compared with a standard repair. However, a large-scale study would be necessary to confirm these results.

RCT Entities:   Population Interventions Outcomes