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Internal Brace

Internal Brace vs. Ligament Reconstruction for Thumb Arthritis

N/A

Recruiting

Research Sponsored by Henry Ford Health System

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 6 months post procedure

Awards & highlights

Study Summary

This trial compares two procedures for treating thumb arthritis: trapeziectomy with ligament reconstruction and tendon interposition vs. trapeziectomy with suture tape suspension of the thumb.

Who is the study for?

This trial is for patients under the care of Henry Ford Orthopedic Service Line with painful thumb arthritis that hasn't improved with standard treatments. It's not suitable for those with serious health issues like heart, kidney, liver, or lung diseases, or heavy substance abuse. People needing other thumb joint procedures can't join.Check my eligibility

What is being tested?

The study compares two surgical techniques for thumb arthritis after removing a wrist bone (trapeziectomy). One group receives a tendon graft (control), while the other uses an InternalBrace device to connect thumb and index finger bones (experimental).See study design

What are the potential side effects?

Potential side effects may include pain at the surgery site, swelling, infection risk, possible damage to nearby nerves or blood vessels, and complications related to anesthesia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post procedure for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Pinch Strength

Secondary outcome measures

PROMIS-UE

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Carpometacarpal (CMC) Suture Tape Ligament ReconstructionExperimental Treatment1 Intervention

Patients in this arm will undergo trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal via Arthrex InternalBrace device. This is the experimental group.

Group II: Carpometacarpal (CMC) Standard Ligament ReconstructionActive Control1 Intervention

Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor

300 Previous Clinical Trials

2,099,834 Total Patients Enrolled

Frequently Asked Questions

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

What is the participant pool size for this research study?

"That is correct. Based on information available at clinicaltrials.gov, this medical experiment has been actively seeking participants since April 1st 2023 and was last updated November 3rd 2023. The study requires 48 volunteers to be recruited from a single location."

Answered by AI

Are participants still being accepted for this research project?

"Affirmative. It is apparent from the information presented on clinicaltrials.gov that this medical trial, which was initially published in April 1st 2023, is actively recruiting participants. 48 individuals need to be enrolled at one of its locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)

Charles S Day 2023. "Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05753891.