Study Comparing SBS and LRTI for Treatment of CMC Arthritis

Last updated: February 26, 2025
Sponsor: Fraser Orthopaedic Research Society
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Treatment

CMC Arthroplasty

Clinical Study ID

NCT05111405
FHREB # 2021-112
  • Ages > 50
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 clinicalvisits as described

  • Able to read and understand English or have interpreter available

Exclusion

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.)

Study Design

Total Participants: 138
Treatment Group(s): 1
Primary Treatment: CMC Arthroplasty
Phase:
Study Start date:
June 20, 2022
Estimated Completion Date:
May 31, 2026

Study Description

LRTI is a well established treatment of CMC arthritis with good results.However, comparable results have also been reported with SBS, with the latter procedure eliminating the need for flexor carpi radialis (FCR) harvest and interposition, resulting in potential shorter OR time and donor site morbidity. To date, there have been biomechanical studies comparing LRTI vs suture button suspension arthroplasty (SBS), and clinical studies comparing trapeziectomy alone vs SBS, but to the best of our knowledge, no random control studies comparing LRTI with SBS.The primary objective is to determine whether treatment with SBS results in improved overall pain relief compared to LRTI as measured by patient reported outcomes.Secondary outcome measures will be to determine if SBS results in shorter OR time and improved grip and pinch strength compared to LRTI, as well as have comparable return to work times and amount of radiographic shortening as shown on radiographs (metacarpal shortening has been felt to lead to decreased grip strength).

Connect with a study center

  • South Campus Research Unit for Bone and Soft Tissue

    Calgary, Alberta T3M1M4
    Canada

    Active - Recruiting

  • Fraser Orthopaedic Research Society

    New Westminster, British Columbia V3L 0E4
    Canada

    Active - Recruiting

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