NCT05111405 Study Comparing SBS and LRTI for Treatment of CMC Arthritis
| NCT ID | NCT05111405 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fraser Orthopaedic Research Society |
| Condition | Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2022-06-20 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 138 participants in total. It began in 2022-06-20 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05111405 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05111405 currently recruiting?
Yes, NCT05111405 is actively recruiting participants. Contact the research team at bperey@shaw.ca for enrollment information.
Where is the NCT05111405 trial being conducted?
This trial is being conducted at Calgary, Canada, New Westminster, Canada.
Who is sponsoring the NCT05111405 clinical trial?
NCT05111405 is sponsored by Fraser Orthopaedic Research Society. The trial plans to enroll 138 participants.