Durolane SJ for Treatment of Rhizarthrosis

Zambon

Status: Completed

Conditions: Rhizarthrosis

Treatments: Device: Durolane SJ

Study type: Interventional

Funder types: Industry

Identifiers

NCT02676284

DURE04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects of both sexes aged 18 to 75 years.
• Diagnosis of Grade II-III rhizarthrosis in either hand, according to the criteria of Eaton and Littler.
• TMC joint pain lasting longer than 6 months and baseline pain value greater than or equal to 4 on the VAS scale (0 to 10) and less than 4 in the contralateral hand joint if there is pain.

Exclusion criteria

• Anticoagulant medication
• Rheumatic disease involving the wrist, hand and fingers, such as rheumatoid arthritis or gout
• Active rheumatoid arthritis
• Previous surgery of the hand
• Systemic infectious processes
• Neoplastic disease
• Subjects with contraindications to hyaluronic acid
• Subjects with known hypersensitivity to hyaluronic acid or any of the components of the preparation under study
• Previous hyaluronic acid injections in the hand
• Subjects likely to miss the clinical follow-up visits
• Taking of analgesics 24 hours before scheduled clinical assessments
• Pregnant subjects
• Any condition that in the opinion of the physician recommends exclusion of the subject

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Durolane SJ

Experimental group

Description:

single dose injection. One infiltration of the study product in the trapeziometacarpal (TMC) joint. The study treatment contains sodium hyaluronate 20 mg/mL, in a 1 mL prefilled syringe.

Treatment:

Device: Durolane SJ