Comparing two surgical treatments for CMC arthritis
A Randomized Prospective Multicenter Study Comparing Suture Button Suspensionplasty (SBS) with Ligament Reconstruction and Tendon Interposition (LRTI)
This study is testing two different surgical options for people with CMC arthritis to see which one helps relieve pain better and gets them back to their normal activities faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Fraser Orthopaedic Research Society Research network |
| Locations | 2 sites (Calgary, Alberta and 1 other locations) |
| Trial ID | NCT05111405 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multi-center, randomized control trial that compares two standard surgical treatments for carpometacarpal (CMC) arthritis: trapezial excision with or without soft tissue interposition and/or ligament reconstruction (LRTI) versus suture button suspension arthroplasty (SBS). The study aims to evaluate the effectiveness of SBS in providing pain relief compared to LRTI, while also assessing factors such as operating room time, grip strength, and return to work times. Patient-reported outcomes will be collected at multiple time points over the course of one year to measure the success of each intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged fifty years or older with isolated carpometacarpal osteoarthritis who have not responded to non-operative management.
Not a fit: Patients who have had previous surgery for CMC arthritis or have other significant hand or wrist pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective surgical option for pain relief from CMC arthritis.
How similar studies have performed: While there have been biomechanical and clinical studies comparing related procedures, this is the first randomized control trial specifically comparing LRTI with SBS.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Calgary, Alberta and 1 other locations
- South Campus Research Unit for Bone and Soft Tissue — Calgary, Alberta, Canada (Recruiting)
- Fraser Orthopaedic Research Society — New Westminster, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Bertrand Perey
- Email: bperey@shaw.ca
- Phone: 604-553-3247
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.