Thumb Metacarpophalangeal Hyperextension in an Arthritic Population; Part 2 (NCT05835830) | Clinical Trial Compass
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Thumb Metacarpophalangeal Hyperextension in an Arthritic Population; Part 2
United States50 participantsStarted 2020-10-06
Plain-language summary
This is the second phase of a clinical study to assess MP hyperextension in CMC arthritis. In the first phase, submitted for publication, the investigators demonstrated that there is poor correlation between dynamic control of the MP joint and the amount of passive hyperextension preoperatively in a sample of patients with CMC arthritis.
Who can participate
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:
* • Adults (18 years of age or older)
* Patients presenting with symptomatic 1st CMC arthritis with or without scaphotrapeziotrapezoid arthritis
* Eaton Classification stage II, III, or IV OA of the first CMC joint based on xrays
* Patients who plan to undergo a ligament reconstruction and tendon interposition (LRTI) or thumb suspensionplasty procedure within 6 months of enrolling to study
* Patients with greater than 20 degrees of passive MP Hyperextension
o Screened by surgeons upon first evaluation in clinic
* Bilateral thumbs included
Exclusion Criteria:
* • \<18 years age
* Prior surgical history of ipsilateral 1st CMC arthroplasty or procedures involving thumb MP or CMC joints
* Prior ipsilateral 1st ray deformity or malunion, distal radial malunion or nonunion, 2nd ray amputation or deformity
* Prior ipsilateral tendon rupture or ipsilateral peripheral nerve palsy
* Inflammatory arthritis
* Post-traumatic CMC arthritis
* Prior trauma to the MP or CMC joints
* Diagnosis of Ehler-Danlos syndrome or other connective tissue disorder
* Concomitant treatment of the MP joint
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
Passive Thumb MP Hyperextension
Timeframe: 12 months
2
Dynamic thumb MP Hyperextension (key pinch)
Timeframe: 12 months
3
Dynamic thumb MP position during cylindrical grasp