OSTENIL® MINI IN THE TREATMENT OF HALLUX LIMITUS. A SINGLE BLIND, RANDOMISED STUDY

Authors: F. Alvarez, M. Pons, J. Solana, E. Rodriguez, R. Viladott, L. Varela

References: Osteoarthritis & Cartilage 2004; 12(Suppl B)

Abstract
Aim: To assess the efficacy and safety of Ostenil® mini (TRB CHEMEDICA AG, Germany), a synovial fluid substitute containing 1.0% hyaluronan, in the treatment of osteoarthritis (OA) of the first metatarsophalangeal (FMTP) joint, compared to standard steroid injection.

Methods: Patients (40-80 years old) with painful OA of the FMTP joint were recruited after giving written informed consent and randomised after confirmation of inclusion/exclusion criteria. Those in the Ostenil® group (OG) received one intra-articular (i.a.) injection of Ostenil® mini (1.0ml), while the steroid group (SG) received one i.a. injection of 1ml of 1% triamcinolone acetonide. Only Paracetamol 500mg tablets were allowed as escape medication. Patients were assessed on days 0, 14, 28, 56 and 84 (end of study). Efficacy was evaluated with the following parameters; pain at the MTP joint (VAS) on palpation, on passive motion and on walking 20m with standard shoes; the Hallux Metatarsophalangeal-interphalangeal Scale of the American Orthopaedic Foot and Ankle Society (AOFAS); general evaluation of treatment by patients and physician (5 level scale); and the use of analgesics. Tolerability to treatment was assessed by patients and physician (5 level scale) and all adverse events were recorded. Variables were analysed using the Chi-square test, non-parametric Mann-Whitney U test, Wilcoxon test and Friedman test.

Results: Thirty-seven patients (mean age: 62.0 years; females 85%) (40 joints) were recruited and completed the study (OG: n=20 joints; SG: n=20 joints). Pain on palpation and on passive motion decreased significantly (P < 0.01) in both groups throughout the study compared to baseline, but there were no differences between groups (P > 0.05). Pain on walking 20m decreased more in the OG being significant (P < 0.05) only in OG. Adverse event appeared in two joints in OG and in one in SG (P > 0.01) and consisted of pain and/or swelling at the injection site.

Conclusion: Ostenil® mini was effective and safe in decreasing pain due to OA of the FMTP joint. Pain and AOFAS total score showed significant improvement with Ostenil® mini compared to a steroid injection. No severe adverse reactions were observed.