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RecruitingNCT05111405

Study Comparing SBS and LRTI for Treatment of CMC Arthritis

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Trial Parameters

ConditionArthritis
SponsorFraser Orthopaedic Research Society
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment138
SexALL
Min Age50 Years
Max AgeN/A
Start Date2022-06-20
Completion2026-02
Interventions
CMC Arthroplasty

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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 suppor

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