Klinické výsledky aplikace fibrínu bohatého na destičky během anatomické rekonstrukce předního zkříženého vazu: výsledky prospektivní randomizované studie
Abstrakt
PURPOSE OF THE STUDY: It was a prospective, randomised, unblinded study. Effects of the application of platelet-rich fibrin (PRF) on the anatomic anterior ligament reconstruction were examined.
MATERIAL AND METHODS: A total of 40 patients who underwent a surgery between 2012 and 2014 were enrolled in the study. The patients were randomised into two groups: the group with PRF application (n=20) and the group without PRF application (n=20, control group).
The study included 11 women and 29 men, with the mean age at the time of inclusion into the study 29.1 years. Vivostat(R) PRF was obtained perioperatively from the patient's blood and applied intraoperatively to the hamstring tendon graft.
The ACL graft healing was assessed through magnetic resonance (MRI) at 6 and 12 months postoperatively. The clinical outcomes (the Lysholm score and the IKDC Subjective score, return to pre-injury sport levels, Pivot-shift test, graft failure) as well as standardised laxity measurements using GenouRob arthrometer were performed preoperatively and 12 months after surgery.
RESULTS: The study was completed by thirty-three (33) patients (17 in the PRF group and 16 in the control group). In two cases, postoperative graft failure was reported (both cases in the control group).
No significant differences were found in the process of graft ligamentization evaluated through MRI (p=0.07). No significant difference between the groups was identified with respect to return to pre-injury sport levels (p=0.232), or the Lysholm score and IKDC Subjective score (p=0.259, and p=0.364 respectively).
The postoperative knee laxity measurement using Genourob arthrometer did not reveal any significant differences between the PRF group and the control group. DISCUSSION: Results similar to those arrived at by our study have recently been published also by other authors worldwide.
We can therefore assume that the application of PRF can be of benefit, especially at the early stage of healing. The results still need to be verified on a larger study group, the study design should focus on the development in the early postoperative period.
CONCLUSIONS: In our study group, no significant difference was observed in the evaluated subjective and objective clinical parameters. Only the parameter regarding the ACL graft failure fell just short of statistical significance, namely to the disadvantage of the group without the PRF application.