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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

SBSvsLRTI Trial 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.Check my eligibility

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.See study design

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.

SBSvsLRTI Trial 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.

SBSvsLRTI Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disabilities of the Arm, Shoulder and Hand Questionnaire

Patient Related Wrist Evaluation Questionnaire

Pain

Secondary outcome measures

Operative Time

Range of Motion

Strength

+1 more

SBSvsLRTI 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 / 3Eligibility criteria met

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Who is running the clinical trial?

Fraser Orthopaedic Research SocietyLead Sponsor

8 Previous Clinical Trials

706 Total Patients Enrolled

Media Library

CMC Arthroplasty (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05111405 — N/A

Arthritis Research Study Groups: Trapezial excision with or without soft tissue interposition and /or ligament reconstruction, Suture button suspension arthroplasty (SBS)

Arthritis Clinical Trial 2023: CMC Arthroplasty Highlights & Side Effects. Trial Name: NCT05111405 — N/A

CMC Arthroplasty (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05111405 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives is this experiment seeking to accomplish?

"The purpose of this twelve-month assessment is to measure Patient Related Wrist Evaluation Questionnaire scores. Secondary outcomes include Transverse volar grip strength, lateral pinch strength, operative time (the duration from the surgeon's first move until their last), and Work Productivity and Activity Impairment: Specific Health Problem Questionnaire results (with lower scores indicating better patient outcomes)."

Answered by AI

Are new participants being welcomed into this clinical research program?

"Yes, the information on clinicaltrials.gov reveals that this experiment is now recruiting participants with an initial posting date of June 20th 2022 and most recent update occurring on the same day. The trial requires 138 test subjects from a single location."

Answered by AI

How many volunteers have been enlisted for this medical experiment?

"Affirmative. On clinicaltrials.gov, it is made clear that this medical trial has not expired; in fact, the posting was updated as recently as June 20th 2022 and 138 patients need to be recruited from one site for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Comparing SBS and LRTI for Treatment of CMC Arthritis

2022. "Study Comparing SBS and LRTI for Treatment of CMC Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05111405.

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