Study Comparing SBS and LRTI for Treatment of CMC Arthritis

NCT05111405 | Recruiting

• 1 other identifier: FHREB # 2021-112
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

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.

Conditions

Arthritis

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale- Pain

  Participants overall assessment of their pain at maximal key pinch loading on a 10 cm visual analogue scale

  12 Months

• Disabilities of the Arm, Shoulder and Hand Questionnaire

  A 30 Item questionnaire that measures an individuals' ability to complete tasks, absorb forces and severity of symptoms. Lower scores will indicated better outcomes.Lower scores will indicate better outcomes.

  12 Months

• Patient Related Wrist Evaluation Questionnaire

  A 15 item questionnaire to measure wrist pain and disability pain in activities of daily living

  12 Months

Secondary Outcomes (4)

• Operative Time

  Intraoperative

• Strength

  12 Months

• Range of Motion

  12 Months

• Work Productivity and Activity Impairment: Specific Health Problem Questionnaire

  12 Months

Study Arms (2)

Trapezial excision with or without soft tissue interposition and /or ligament reconstruction

OTHER

The participating surgeon will perform their usual version of a trapeziectomy and thumb metacarpal using either FCR tendon or abductor hallucis longs (APL) tendon. Tendon interposition will be left to the surgeon's discretion.

Procedure: CMC Arthroplasty

Suture button suspension arthroplasty (SBS)

OTHER

Dorso-radial incision, capsulotomy between extensor pollicis brevis (EPB) and APL protecting the radial artery. A second incision is made on dorsum of hand between the 2nd and 3rd MCs. A cannulated drill with suture passer is passed from base of 1st MC to mid 2nd MC. The TightropeTM is passed from 1st to second MC with one button on the base of the 1st MC. Trapeziectomy is then performed using a cruciate osteotomy and rongeurs. The thumb is adducted against index MC to avoid excessive tightening and the suture is tied over a second button on the 2nd MC. Closure of capsule with Vicryl. Closure of skin with running Prolene suture.

Procedure: CMC Arthroplasty

Interventions

CMC Arthroplasty PROCEDURE

Surgical intervention to treat CMC arthritis

Suture button suspension arthroplasty (SBS); Trapezial excision with or without soft tissue interposition and /or ligament reconstruction

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Fraser Orthopaedic Research Society: lead

Study Sites (2)

South Campus Research Unit for Bone and Soft Tissue

Calgary, Alberta, T3M1M4, Canada

RECRUITING

Fraser Orthopaedic Research Society

New Westminster, British Columbia, V3L 0E4, Canada

RECRUITING

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Central Study Contacts

Bertrand Perey

CONTACT

604-553-3247; bperey@shaw.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, prospective trial.

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: June 20, 2022
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)