An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study

Study Overview
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Brief Summary
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The purpose of this study is to find out if hyaluronan, an injectable medication for knee arthritis, also works for arthritis at the base of the thumb. This study will also evaluate how good ultrasound is at visualizing medication in the thumb joint. We are no longer recruiting for this part of the open label trial.

Official Title
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An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study

Conditions
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Carpometacarpal Osteoarthritis

Intervention / Treatment
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* Device: Synvisc (hylan G-F20)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radiographic evidence of at least moderate narrowing (joint space < 1mm) or the presence of osteophytes or sclerosis at the Carpometacarpal joint Patient complaint of unacceptable pain despite modification of activity, a trial of splinting and a therapeutic dose of NSAIDS If bilateral disease, only the most severely involved hand, (as defined by VAS for pain), will be entered in the study. Proficiency in English. Exclusion Criteria: Previous bad injury to the thumb Previous hand surgery on the study thumb Known hand comorbidities (i.e. carpal tunnel syndrome, de Quervains Tenosynovitis etc) Rheumatoid arthritis or lupus Bleeding problems Being on blood thinners (except aspirin) Known allergies to any of the medications being used Allergies to chicken products Current use of oral steroids Cancer that is not cured or in remission Severe diabetes A serious infection somewhere else in the subject's body

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 95 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: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilot Study of Hylan G-F 20<br>32 Subjects have received Synvisc Injections and followed for 6 months. | Device: Synvisc (hylan G-F20)<br>* 32 subjects in the pilot study have received 3 1ml injections of Synvisc intraarticular over the course of 3 weeks and then followed for 6 months post injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Disabilities of the Arm, Shoulder and Hand Outcome Measure | The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. Scores are transformed to a 0-100 scale, with a higher value indicating greater disability. The change in DASH (delta) over those 6 months was recorded. | 26 weeks (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale for Pain | The visual analog scale for pain (VAS) is a test requiring a patient to indicate along a line how much pain they are experiencing between 0-100. A score of 100 indicates the maximum possible pain level and a score of 0 indicates no pain. Scores are recorded as whole number integers. The change in VAS (delta) over those 6 months was recorded. | 26 weeks (6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Outcomes, Osteoarthritis, Hyaluronan, Carpometacarpal