BACKGROUND: To determine the efficacy, safety and dose dependency of intra-articular Orthovisc(®) hyaluronic acid injections in the ankle. METHODS: A prospective single blinded study in patients with symptomatic ankle-osteoarthritis. Patients were randomly allocated to 1, 2, 3 ml, or 3 weekly injections of 1 ml (3 × 1 ml). Primary outcome was 'pain during walking' at 15 weeks measured on a 100mm VAS. RESULTS:Twenty-six patients (ITT) participated. The 3 × 1 ml dose group showed statistically significant decreases at week 7 for 'pain during walking' and 'pain at rest' (p=0.046). At week 15 decreases were significant for 'pain at rest' (p=0.046). There was no significant decrease of VAS-scores in any of the single dose groups. Seven patients experienced temporary local swelling and increased pain in the injected ankle. CONCLUSIONS: Orthovisc(®) viscosupplementation in the ankle joint is effective and well tolerated. The 3 × 1 ml dose regimen shows the best results.
RCT Entities:
BACKGROUND: To determine the efficacy, safety and dose dependency of intra-articular Orthovisc(®) hyaluronic acid injections in the ankle. METHODS: A prospective single blinded study in patients with symptomatic ankle-osteoarthritis. Patients were randomly allocated to 1, 2, 3 ml, or 3 weekly injections of 1 ml (3 × 1 ml). Primary outcome was 'pain during walking' at 15 weeks measured on a 100mm VAS. RESULTS: Twenty-six patients (ITT) participated. The 3 × 1 ml dose group showed statistically significant decreases at week 7 for 'pain during walking' and 'pain at rest' (p=0.046). At week 15 decreases were significant for 'pain at rest' (p=0.046). There was no significant decrease of VAS-scores in any of the single dose groups. Seven patients experienced temporary local swelling and increased pain in the injected ankle. CONCLUSIONS: Orthovisc(®) viscosupplementation in the ankle joint is effective and well tolerated. The 3 × 1 ml dose regimen shows the best results.
Authors: Sen Liu; Qing-Song Zhang; William Hester; Michael J O'Brien; Felix H Savoie; Zongbing You Journal: Am J Sports Med Date: 2012-03-16 Impact factor: 6.202
Authors: Angelo Boffa; Davide Previtali; Giorgio Di Laura Frattura; Francesca Vannini; Christian Candrian; Giuseppe Filardo Journal: Int Orthop Date: 2020-07-09 Impact factor: 3.075
Authors: Javier Adrián Calles; Jorge Aníbal Ressia; Juan Manuel Llabot; Enrique Marcelo Vallés; Santiago Daniel Palma Journal: Sci Pharm Date: 2015-07-29