Daniele Clementi1, Riccardo D'Ambrosi2,3, Paride Bertocco1, Miguel Simon Bucci4, Carlo Cardile5, Paolo Ragni4, Graziella Giaffreda1, Vincenza Ragone6. 1. Azienda Socio Sanitaria Territoriale Rhodense, Presido Ospedaliero di Rho, Unità Operativa Ortopedia e Traumatologia, Rho, Italy. 2. IRCCS Istituto Ortopedico Galeazzi, Milan, Italy. riccardo.dambrosi@hotmail.it. 3. Dipartimento di Scienze Biomediche per la Salute, Università degli Studi di Milano, Milan, Italy. riccardo.dambrosi@hotmail.it. 4. Azienda Socio Sanitaria Territoriale Rhodense, Presido Ospedaliero di Garbagnate, Unità Operativa Ortopedia e Traumatologia, Garbagnate, Italy. 5. Azienda Socio Sanitaria Territoriale Rhodense, Presido Ospedaliero di Bollate, Unità Operativa Ortopedia e Traumatologia, Bollate, Italy. 6. IRCCS Policlinico San Donato, San Donato Milanese, Italy.
Abstract
BACKGROUND:Viscosupplementation with hyaluronic acid (HA) is increasingly used for the treatment of hip osteoarthritis (OA). The purpose of this study was to compare the efficacy of intra-articular injections of an ultra-high molecular weight viscosupplement (UHMW-HA, Fermathron S) with a medium molecular weight hyaluronan (MMW-HA, Hyalubrix 60) in hip OA. METHODS:Fifty-four patients with hip OA grade 3 on the Kellgren/Lawrence scale were randomized. All infiltrations were performed under ultrasound guidance. Evaluation was performed preoperatively and at 1, 3, 6 and 12 months after infiltration. Patients were clinically evaluated using Lequesne index, VAS and WOMAC score. RESULTS:Fifty patients, including 27 in the MMW-HA group and 23 in the UHMW-HA group, completed the follow-up. No significant difference was found between the two groups in terms of VAS, WOMAC or Lequesne index preoperatively or at 1, 3, 6 and 12 months after viscosupplementation. A stratified analysis was performed to study the development over time of Lequesne index of patients aged ≤ 55 years, > 55 and, ≤ 70 years and > 70 years and Lequesne index was different between the three age-stratified subgroups only in the MMW-HA group. The subgroup of older patients showed a higher Lequesne index than the subgroups of younger patients (p < 0.05). CONCLUSIONS:UHMW-HA is a safe and effective treatment for hip osteoarthritis. A single dose of UHMW-HA was as effective as two doses of MMW-HA resulting in similar reductions of pain and disability. STUDY DESIGN: Multicenter, independent, prospective, randomized controlled trial with level of evidence 1.
RCT Entities:
BACKGROUND: Viscosupplementation with hyaluronic acid (HA) is increasingly used for the treatment of hip osteoarthritis (OA). The purpose of this study was to compare the efficacy of intra-articular injections of an ultra-high molecular weight viscosupplement (UHMW-HA, Fermathron S) with a medium molecular weight hyaluronan (MMW-HA, Hyalubrix 60) in hip OA. METHODS: Fifty-four patients with hip OA grade 3 on the Kellgren/Lawrence scale were randomized. All infiltrations were performed under ultrasound guidance. Evaluation was performed preoperatively and at 1, 3, 6 and 12 months after infiltration. Patients were clinically evaluated using Lequesne index, VAS and WOMAC score. RESULTS: Fifty patients, including 27 in the MMW-HA group and 23 in the UHMW-HA group, completed the follow-up. No significant difference was found between the two groups in terms of VAS, WOMAC or Lequesne index preoperatively or at 1, 3, 6 and 12 months after viscosupplementation. A stratified analysis was performed to study the development over time of Lequesne index of patients aged ≤ 55 years, > 55 and, ≤ 70 years and > 70 years and Lequesne index was different between the three age-stratified subgroups only in the MMW-HA group. The subgroup of older patients showed a higher Lequesne index than the subgroups of younger patients (p < 0.05). CONCLUSIONS: UHMW-HA is a safe and effective treatment for hip osteoarthritis. A single dose of UHMW-HA was as effective as two doses of MMW-HA resulting in similar reductions of pain and disability. STUDY DESIGN: Multicenter, independent, prospective, randomized controlled trial with level of evidence 1.
Entities:
Keywords:
Biology of cartilage; Hip osteoarthritis; Hyaluronic acid; Randomized clinical trial; Regenerative medicine
Authors: A Migliore; S Tormenta; B Laganà; P Piscitelli; M Granata; E Bizzi; U Massafra; F Giovannangeli; C Maggi; R De Chiara; F Iannessi; A Sanfilippo; M Camminiti; M G Pagano; G Bagnato; G Iolascon Journal: Eur Rev Med Pharmacol Sci Date: 2013-07 Impact factor: 3.507