Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
Healthy Volunteers
NCT05111405

Study Comparing SBS and LRTI for Treatment of CMC Arthritis

Led by Fraser Orthopaedic Research Society · Updated on 2025-02-28

138

Participants Needed

2

Research Sites

201 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Study Comparing SBS and LRTI for Treatment of CMC Arthritis

Who Can Participate

Age: 50Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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.)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

South Campus Research Unit for Bone and Soft Tissue

Calgary, Alberta, Canada, T3M1M4

Actively Recruiting

2

Fraser Orthopaedic Research Society

New Westminster, British Columbia, Canada, V3L 0E4

Actively Recruiting

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Research Team

B

Bertrand Perey

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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Study Comparing SBS and LRTI for Treatment of CMC Arthritis | DecenTrialz