Randomized, multicentre, controlled, parallel, double-blind clinical trial with treatment masking to the evaluator, evaluating the efficacy of autologous Platelet-Rich Plasma (PRP) in the treatment of “tennis leg” type muscle tears
Objectives
The high vascularization of muscle leads to frequent hematomas when injured. This study is based on the hypothesis that when the muscle hematoma is evacuated and Platelet-rich plasma and leukocyte poor (LP-PRP) is injected in the remaining cavity, then the risk of recurrence decreases due to its coagulant and adherent effect, while inflammation is limited, and the regenerative process is improved by minimizing fibrosis.
Methodology
Phase III multicentre, randomized, parallel and controlled clinical trial in 71 patients, 81.8% men aged 45.6 years old on average, with “tennis leg” lesions of the calf and of the anterior rectum (posterior fascia).
Hematoma was evacuated in all patients. Patients in the PRP group (n = 33) had a dose of LP-PRP adapted to the remaining cavity, with an approximate content of 2 million platelets/ml. In the control group (n = 38) evacuation was performed, but without PRP infiltration.
The main efficacy endpoint was time to recovery.
Results
Safety
No adverse effects related to infiltrations were reported.
Efficacy
The time to recovery completion after treatment was 31.63 days in the PRP group and 38.43 days in the control group (p = 0,261).
Pain decreased over time in both groups, but no statistically significant differences were observed.
7 patients in the control group and only 1 from the PRP group relapsed.
Conclusions
Non-significant results in terms of recovery time could be attributed to the delay in which the PRP was administered to patients after the injury, which ranged between 2 and 3 weeks.
According to previous studies (Anitua et al.), PRP exerts its effects during the first 2 hours after the injury, and due to physiological reasons, it could lose its effectiveness after 2 days. It would be necessary to conduct a new study with a greater number of patients and to perform an earlier infiltration to confirm the results.
Publications
Martinez-Zapata MJ, Orozco L, Balius R, et al. Efficacy of autologous platelet-rich plasma for the treatment of muscle rupture with haematoma: a multicentre, randomised, double-blind, placebo-controlled clinical trial. Blood Transfus. 2016;14(2):245-54.
STUDY DESCRIPTION
Multicentre study
Development phase: III
Status: completed
Sponsor: ITRT
Investigators: MJ Martínez, R Balius, Ll Orozco, R Soler Rich, G Rodas, Ll Til, J García, X Bonfill, J Sales, F Soler, A Bosch, J Grifols, X Peirau, J Permanyer, R Cugat, M Rius, J Boffa
CEIC: Centro Médico Teknon
CRO: Centro Cochrane Iberoamericano
Ayuda a la investigación: Fundación Universal
Participating entities: Centro Médico Teknon, Banc de Sang i Teixits (BST), Consell Catalá de l’Esport (Residencia Blume), Centre d’Alt Rendiment (CAR-Consorci Sanitari de Terrassa), Fútbol Club Barcelona, EGARSAT, Centro Cochrane Iberoamericano, Teknon Foundation, Fundació Institut de Recerca Hospital de Sant Pau, Hospital Montserrat (Lleida), INEFC (Lleida), Centre Mèdic Les Moreres, Mútua de Futbolistas (Cataluña)
Funding: Clinical trial endowed wih FIS (nº PI080724)