Study Comparing SBS and LRTI for Treatment of CMC Arthritis (NCT05111405) | Clinical Trial Compass
RecruitingNot Applicable
Study Comparing SBS and LRTI for Treatment of CMC Arthritis
Canada138 participantsStarted 2022-06-20
Plain-language summary
A multi-center, randomized control trial comparing the two standard of care surgical treatments for CMC arthritis ; trapezial excision with or without soft tissue interposition and /or ligament reconstruction (LRTI) versus the suture button suspension arthroplasty (SBS). Patient reported outcomes will be collected at 6 and 6 weeks, 3, 6, and 12 months.
Who can participate
Age range
50 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:
* Age fifty years or older
* Isolated carpometacarpal (trapeziometacarpal) osteoarthritis
* Failure to respond to non-operative management
* Willing and able to consent on their own behalf and follow the protocol and clinical visits as described
* Able to read and understand English or have interpreter available
Exclusion Criteria:
* Previous surgery for CMC arthritis
* Duration of symptoms for less than 6 months
* Greater than or equal to 30 degrees of ipsilateral metacarpophalangeal (MCP) hyperextension
* Scaphotrapeziotrapezoidal (stage 4 CMC) arthritis
* Other significant ipsilateral wrist or hand pathology
* A history of inflammatory arthropathy
* A requirement for concomitant surgery for another condition
* Any previous hand or wrist fracture
* Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged patients without adequate support, etc.)
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
Visual Analog Scale- Pain
Timeframe: 12 Months
2
Disabilities of the Arm, Shoulder and Hand Questionnaire