CompletedNot Applicable

A Case Series Comparing T+LRTI to Partial Trapeziectomy for Thumb Osteoarthritis

20 participantsStarted 2012-03-01

Plain-language summary

The purpose of this study was to measure the differences in Health Related Quality of Life (HRQOL) and functional measurements between two groups of patients with Carpometacarpal Osteoarthritis of the thumb.

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: * Diagnosis of advanced stage (Eaton stages II-IV) Carpometacarpal joint (CMCJ) osteoarthritis (OA of the thumb * Willingness to undergo surgery for CMCJ OA; * Over the age of 18; * Able to provide informed consent; and * Ability to read and comprehend English to complete the HRQOL questionnaires Exclusion Criteria: * 1\) Diagnosis of Eaton stage I CMCJ OA of the thumb \[17\]; 2) Under the age of 18; 3) Presence of any concomitant hand pathology (including rheumatoid arthritis, neuropathy and traumatic arthritis); and 4) Previous surgery on the same hand or currently under consideration for other unrelated hand surgery

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

Change in Health Related Quality of Life (HRQOL) as measured by the Short Form 36v2 (SF-36)

Timeframe: 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively

Change in Health Related Quality of Life (HRQOL) as measured by the Disabilities of the Arm, Shoulder and Hand (DASH)

Timeframe: 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively

Change in HRQOL as measured by The EuroQol-5D-3L [EQ-5D]

Timeframe: 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively

Trial details

NCT IDNCT03392454

SponsorMcMaster University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-11-30

View on ClinicalTrials.gov More Arthritis trials

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.

What they're measuring

Change in Health Related Quality of Life (HRQOL) as measured by the Short Form 36v2 (SF-36)

Timeframe: 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively

Change in Health Related Quality of Life (HRQOL) as measured by the Disabilities of the Arm, Shoulder and Hand (DASH)

Timeframe: 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively

Change in HRQOL as measured by The EuroQol-5D-3L [EQ-5D]

Timeframe: 1 week pre-operatively plus 1, 3, 6 and 12 month post-operatively