TerminatedNot Applicable

MiniTightRope Suspensionplasty Compared With LRTI for the Treatment of Basilar Thumb Arthritis

United States7 participantsStarted 2015-10

Plain-language summary

This prospective randomized trial aims to ascertain differences in outcome measures for the operative treatment of basilar thumb arthritis by comparing the two most common surgical treatments: LRTI and mini tightrope suspensionplasty. The Investigators will evaluate both subjective and objective data to determine if a particular surgical method offers more favorable outcomes.

Who can participate

Age range

18 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: * Radiographically diagnosed Stage II-IV basilar thumb arthritis as described by the Eaton and Littler classification system on either the right or left hand. Exclusion Criteria: * To have a history of prior surgical intervention for basilar thumb arthritis, trauma to the hand or wrist, or debilitating injury to the upper extremity. * Patients under the age of 18 or with a history of a debilitating neurologic injury, either acute or chronic, to the upper extremity will be excluded. * Patients that are non-operative candidates due to medical comorbidities will also be excluded.

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

Disabilities of Arm, Shoulder & Hand (DASH) questionnaire

Timeframe: An average of 5 years.

SF-36 patient survey scores

Timeframe: On the follow-up visits

Patient satisfaction surveys

Timeframe: An average of 5 years.

Pinch/grip strength

Timeframe: An average of 5 years.

Trial details

NCT IDNCT02591368

SponsorOrlando Health, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10

View on ClinicalTrials.gov More Arthritis trials

Plain-language summary

Who can participate

Age range

18 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.