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Procedure

CMC Arthroplasty for Thumb Arthritis (SBSvsLRTI Trial)

N/A

Recruiting

Research Sponsored by Fraser Orthopaedic Research Society

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Failure to respond to non-operative management

Age fifty years or older

Must not have

Duration of symptoms for less than 6 months

Greater than or equal to 30 degrees of ipsilateral metacarpophalangeal (MCP) hyperextension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two standard surgical treatments for arthritis of the thumb joint to see which is more effective.

Who is the study for?

This trial is for individuals over 50 with isolated thumb arthritis who haven't improved with non-surgical treatments. Participants must be able to consent, follow the study plan, and attend clinical visits. Those with advanced arthritis stages, previous CMC surgeries, other hand conditions, inflammatory diseases or unable to maintain follow-up are excluded.

What is being tested?

The study compares two surgical methods for treating thumb arthritis: ligament reconstruction and tendon interposition (LRTI) versus suture button suspension arthroplasty (SBS). Patient outcomes will be evaluated at multiple time points up to one year post-surgery.

What are the potential side effects?

Potential side effects from these surgeries may include pain at the surgery site, infection risk, reduced thumb movement or strength, stiffness in the hand or wrist area and possible need for additional future surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition did not improve with non-surgical treatments.

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I am 50 years old or older.

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I have arthritis in the base joint of my thumb.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My symptoms have been present for less than 6 months.

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My finger joint bends backward more than 30 degrees.

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I have other major issues with the same side wrist or hand.

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I have advanced arthritis in my wrist.

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I have had surgery for arthritis in my thumb.

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I have had a fracture in my hand or wrist before.

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I have a history of joint inflammation.

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I need surgery for a condition other than my current illness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disabilities of the Arm, Shoulder and Hand Questionnaire

Patient Related Wrist Evaluation Questionnaire

Pain

Secondary study objectives

Operative Time

Range of Motion

Strength

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Trapezial excision with or without soft tissue interposition and /or ligament reconstructionExperimental Treatment1 Intervention

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.

Group II: Suture button suspension arthroplasty (SBS)Experimental Treatment1 Intervention

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.

0 / 11Eligibility criteria met