Durolane SJ for Treatment of Rhizarthrosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rhizarthrosis

Intervention / Treatment
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* Device: Durolane SJ


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Durolane SJ<br>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. | Device: Durolane SJ<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Pain Measured by the VAS Scale | Visual Analogue Scale (VAS) pain in injected hand. The VAS scale ranges from 0 cm (least pain) to 10 cm (most pain). A Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. | Baseline and 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Biomechanical Function, Measured by the Quick DASH Questionnaire | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities.This is a self-report questionnaire that patients can use to rate difficulty and interference with daily life. Quick DASH questionnaire is a shortened version of the DASH Outcome Measure which uses 11 items to measure physical function and symptoms in people with musculoskeletal disorders of the upper limb. Possible scores range from 11-55, which can be remapped to a 0-100 scale. This latter ranges from 0 units (most functionality) to 100 units (least functionality). | Baseline and 26 weeks |