Study Comparing SBS and LRTI for Treatment of CMC Arthritis (SBSvsLRTI)

A Randomized Prospective Multicenter Study Comparing Suture Button Suspensionplasty (SBS) with Ligament Reconstruction and Tendon Interposition (LRTI)

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.

Study Overview

• Status: Recruiting
• Conditions: Arthritis
• Intervention / Treatment: Procedure: CMC Arthroplasty

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bertrand Perey; Phone Number: 604-553-3247; Email: bperey@shaw.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3M1M4
      • Recruiting
      • South Campus Research Unit for Bone and Soft Tissue
      • Contact: Neil White; Phone Number: 403-956-3687
      • Contact: Adina Tarcea; Phone Number: 403-956-3687; Email: shcorthoresearch@ucalgary.ca
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 0E4
      • Recruiting
      • Fraser Orthopaedic Research Society
      • Contact: Bertrand Perey, MD; Phone Number: 604-553-3247
      • Contact: Kyrsten Butterfield, BSc; Phone Number: 604-553-3247; Email: kyrsten.butterfield@fraserhealth.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Trapezial excision with or without soft tissue interposition and /or ligament reconstruction; 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; Surgical intervention to treat CMC arthritis
Other: Suture button suspension arthroplasty (SBS); 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; Surgical intervention to treat CMC arthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Time	Time as recorded from the surgeons start of the procedure until the surgeons stop.	Intraoperative
Strength	Transverse volar grip strength as measured by a dynamometer and key and lateral pinch strength measure by a pinch gauge	12 Months
Range of Motion	Thumb flexion will be measured from the top of the thumb (pulp) to the base of the 5th metacarpal (pinky finger). Retropulsion measured as the distance between the thumb and table when the dorsum of the hand is pressed against the table.	12 Months
Work Productivity and Activity Impairment: Specific Health Problem Questionnaire	A questionnaire pertaining to the effect of the participant's CMC arthritis on their ability to work and perform regular activities. Lower scores will indicate better outcomes.	12 Months

Collaborators and Investigators

• Sponsor: Fraser Orthopaedic Research Society

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Arthritis
• Other Study ID Numbers: FHREB # 2021-112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No