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NCT Number: NCT05111405

Study Comparing SBS and LRTI for Treatment of CMC Arthritis

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.

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Key information

Conditions

Arthritis Joint Diseases Musculoskeletal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Campus Research Unit for Bone and Soft Tissue, Calgary, Alberta, Canada

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

CMC Arthroplasty

Procedure

Surgical intervention to treat CMC arthritis

Primary outcomes

  1. Visual Analog Scale- Pain

    Time frame: 12 Months

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

  2. Disabilities of the Arm, Shoulder and Hand Questionnaire

    Time frame: 12 Months

    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.

  3. Patient Related Wrist Evaluation Questionnaire

    Time frame: 12 Months

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

Secondary outcomes

  1. Operative Time

    Time frame: Intraoperative

    Time as recorded from the surgeons start of the procedure until the surgeons stop.

  2. Strength

    Time frame: 12 Months

    Transverse volar grip strength as measured by a dynamometer and key and lateral pinch strength measure by a pinch gauge

  3. Range of Motion

    Time frame: 12 Months

    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.

  4. Work Productivity and Activity Impairment: Specific Health Problem Questionnaire

    Time frame: 12 Months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bertrand Perey

CONTACT

[email protected]

604-553-3247

Sponsors and collaborators

Lead sponsor

Fraser Orthopaedic Research Society

Network

Registry information

Official study title

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

Acronym: SBSvsLRTI

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2021
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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