Study Comparing SBS and LRTI for Treatment of CMC Arthritis
Recruiting
N/AInterventional Study
Arthritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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At a Glance
Age
50 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
138 (estimated)
Sponsor
Fraser Orthopaedic Research Society · Research network
Who this trial is looking for
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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.
Trial Locations
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Status
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 Eng…
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.)
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