An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study (NCT00198029) | Clinical Trial Compass
CompletedNot Applicable
An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
United States32 participantsStarted 2004-10
Plain-language summary
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.
Who can participate
Age range
45 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Disabilities of the Arm, Shoulder and Hand Outcome Measure