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Procedure

Internal Brace vs LRTI for Thumb Osteoarthritis

N/A

Waitlist Available

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing whether a new treatment for carpal metacarpal osteoarthritis (CMC OA) is better than the current standard of care. The new treatment is called internal brace (IB), and it is being compared to the current standard, which is called ligament reconstruction and tendon interposition (LRTI). The trial will test whether IB is more effective than LRTI in terms of patient-reported outcomes, objective clinical outcomes, and return to work/activity.

Who is the study for?

This trial is for individuals over 50 years old with thumb osteoarthritis, specifically at the carpometacarpal joint. It's not suitable for those with rheumatoid or inflammatory arthritis, surgical treatment of thumb hyperextension, or a history of chronic opioid use.Check my eligibility

What is being tested?

The study compares two surgeries for thumb osteoarthritis: traditional ligament reconstruction and tendon interposition (LRTI) versus a newer method using an internal brace (IB). The goal is to see if IB allows patients to return to daily activities and work sooner than LRTI.See study design

What are the potential side effects?

Potential side effects may include pain at the surgery site, reduced thumb movement, weakness in grip or pinch strength, complications leading to additional surgery, and other general risks associated with hand surgeries.

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

Follow-up retention rate

Randomization rate

Secondary outcome measures

Complications

Grip Strength

Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity and Physical Function scores

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Internal BraceExperimental Treatment1 Intervention

Patients will undergo Internal Brace procedure for thumb CMC OA.

Group II: LRTIActive Control1 Intervention

Patients will undergo ligament reconstruction tendon interposition (most commonly performed surgery for thumb CMC OA) and serve as control group.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,679 Total Patients Enrolled

Media Library

Trapeziectomy with Internal Brace (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03971188 — N/A

Thumb Osteoarthritis Research Study Groups: LRTI, Internal Brace

Thumb Osteoarthritis Clinical Trial 2023: Trapeziectomy with Internal Brace Highlights & Side Effects. Trial Name: NCT03971188 — N/A

Trapeziectomy with Internal Brace (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03971188 — N/A

Frequently Asked Questions

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

Are there any vacant spots for potential participants in this investigation?

"According to clinicaltrials.gov, this medical experiment is not enrolling any more patients at the present time. Posted on January 1 2020 and last edited April 26 2022, it has since been superseded by 613 other trials that are actively accepting participants."

Answered by AI

What are the chief goals of this investigation?

"The duration of this medical trial is around 12 months and its primary outcome is the randomization rate. Secondary objectives include assessing thumb range of motion at specific joints, collecting PROMIS Upper Extremity and Physical Function scores via iPad devices, as well as measuring pinch strength with a gauge and grip strength using dynamometer. All results are normalized to mean score 50 standard deviations 10 in order to counteract floor or ceiling effects while making sure that data remains comprehensible. Higher values on all PROMIS CATs indicate greater levels of the domain measured; for instance higher Physical Function scores imply better functioning overall. The two aforementioned outcomes will be reported separately rather"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

LRTI vs Internal Brace for CMC OA

2020. "LRTI vs Internal Brace for CMC OA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03971188.