Durolane SJ for Treatment of Rhizarthrosis

Status Completed

Clinical Trial Summary

The main objective of the trial is to assess the clinical changes in terms of physical examination, VAS Scale and the Quick-DASH questionnaire, and the biomechanical parameters in terms of mobility of the TMC joint, the grip strength of the hand and lateral pinch strength in patients with rhizarthrosis after administration of viscosupplementation. The secondary objectives of the trial will be to assess the safety of the treatment with viscosupplementation, and the correlation between the clinical and biomechanical changes at the end of the trial.

Clinical Trial Description

This is a prospective, open, non-comparative study in 36 subjects with rhizarthrosis, comparing signs and symptoms before and after a single injection of DUROLANE SJ in the affected hand. Subjects were assessed pre-treatment and at 1, 3, and 6 months post-treatment. This study is associated with a post marketing commitment with the European Notified Body, BSI, to confirm DUROLANE SJ's effectiveness in rhizarthrosis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02676284
Study type	Interventional
Source	Zambon SAU
Contact
Status	Completed
Phase	N/A
Start date	May 2013
Completion date	July 2014

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