NCT02676284

Durolane SJ for Treatment of Rhizarthrosis

Study of the Clinical and Biomechanical Effectiveness of Durolane SJ in Rhizarthrosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Zambon SAU · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Rhizarthrosis

Interventions

Type	Name	Description
DEVICE	Durolane SJ	DUROLANE® is a clear, transparent, viscous gel of highly purified, stabilized, non-animal-derived sodium hyaluronate that is biosynthesized using bacterial fermentation. NASHA technology is used to stabilize naturally entangled hyaluronic acid (HA) chains to produce a gel. The gel is suspended in phosphate-buffered saline at a concentration of 20 mg/mL .

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2016-02-08
• Last updated: 2021-12-03
• Results posted: 2021-12-03

Locations

3 sites across 1 country: Spain

Regulatory

• FDA-regulated device study