CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Durolane SJdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02676284
NCT02676284N/ACompleted
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Study of the Clinical and Biomechanical Effectiveness of Durolane SJ in Rhizarthrosis

Zambon SAU·interventional·Posted Feb 8, 2016·Updated Dec 3, 2021

In Brief

A clinical study evaluating Durolane SJ for Rhizarthrosis. Completed, enrolled 36 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhizarthrosis
CountriesSpain
CollaboratorsBioventus LLC

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2016
Enrollment StartMay 1, 2013
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.4 years ago

Interventions

Durolane SJdevice

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 .