Víctor Vaquerizo1, Sabino Padilla2, José Javier Aguirre3, Leire Begoña2, Gorka Orive4,5,6, Eduardo Anitua2. 1. Department of Orthopaedic Surgery, Príncipe de Asturias University Hospital, Ctra. Alcalá-Meco s/n, 28805, Alcalá de Henares, Spain. vaquerizovictor@yahoo.es. 2. BTI Biotechnology Institute ImasD, S.L. C/Jacinto Quincoces, 39, 01007, Vitoria, Spain. 3. Pathology Department, Hospital Universitario de Álava (HUA), C/José Achotegui s/n, 01008, Vitoria, Spain. 4. BTI Biotechnology Institute ImasD, S.L. C/Jacinto Quincoces, 39, 01007, Vitoria, Spain. gorka.orive@ehu.es. 5. Laboratory of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of the Basque Country, Vitoria, Spain. gorka.orive@ehu.es. 6. Networking Biomedical Research Center on Bioengineering, Biomaterials and Nanomedicine, CIBER-BBN, SLFPB-EHU, Vitoria, Spain. gorka.orive@ehu.es.
Abstract
PURPOSE: To assess the clinical efficacy and safety of a treatment based on one cycle versus two cycles of intra-articular injections of plasma rich in growth factors (PRGF-Endoret) on patients with knee osteoarthritis (OA). METHODS:Ninety patients with knee OA were included and evaluated. A total of 48 patients received one cycle (OC group) (3 injections on a weekly basis), while 42 patients receivedtwo cycles of PRGF-Endoret (TC group) spaced 6 months between them. Patients were evaluated with LEQUESNE and WOMAC scores before treatment and after 48 weeks. Safety assessment was also performed. RESULTS: A significant reduction of all assessed outcome measures was shown for both groups at 48 weeks compared with baseline values (P < 0.001). Patients of TCs group showed a significantly higher reduction (P < 0.05) in WOMAC stiffness subscales. Regarding LEQUESNE INDEX, a significantly higher reduction was observed in the TC group in all subscales except in pain score. In the maximum walking distance subscale (MCD), the improvement rate was 31.8% higher for the TCs group compared with the OC group (P < 0.01). In addition, the TC group showed a significant improvement in LEQUESNE activities of daily living (ADV) and global subscales of 14.7 and 11.8% (P < 0.05) higher, respectively, than the OC group. CONCLUSIONS: Treatment with two cycles of PRGF did not show a significantly higher pain reduction compared with one cycle treatment. However, two cycles of PRGF showed a significant improvement in WOMAC stiffness, LEQUESNE MCD, LEQUESNE ADV and LEQUESNE global subscales. Therefore, patients treated with two cycles present an improvement in quality of life. LEVEL OF EVIDENCE: II.
RCT Entities:
PURPOSE: To assess the clinical efficacy and safety of a treatment based on one cycle versus two cycles of intra-articular injections of plasma rich in growth factors (PRGF-Endoret) on patients with knee osteoarthritis (OA). METHODS: Ninety patients with knee OA were included and evaluated. A total of 48 patients received one cycle (OC group) (3 injections on a weekly basis), while 42 patients received two cycles of PRGF-Endoret (TC group) spaced 6 months between them. Patients were evaluated with LEQUESNE and WOMAC scores before treatment and after 48 weeks. Safety assessment was also performed. RESULTS: A significant reduction of all assessed outcome measures was shown for both groups at 48 weeks compared with baseline values (P < 0.001). Patients of TCs group showed a significantly higher reduction (P < 0.05) in WOMAC stiffness subscales. Regarding LEQUESNE INDEX, a significantly higher reduction was observed in the TC group in all subscales except in pain score. In the maximum walking distance subscale (MCD), the improvement rate was 31.8% higher for the TCs group compared with the OC group (P < 0.01). In addition, the TC group showed a significant improvement in LEQUESNE activities of daily living (ADV) and global subscales of 14.7 and 11.8% (P < 0.05) higher, respectively, than the OC group. CONCLUSIONS: Treatment with two cycles of PRGF did not show a significantly higher pain reduction compared with one cycle treatment. However, two cycles of PRGF showed a significant improvement in WOMAC stiffness, LEQUESNEMCD, LEQUESNE ADV and LEQUESNE global subscales. Therefore, patients treated with two cycles present an improvement in quality of life. LEVEL OF EVIDENCE: II.
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