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Immobilization Duration for Thumb Osteoarthritis

N/A
Recruiting
Led By Jennifer Wolf, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 40 years old
Patients undergoing arthroplasty of the first CMC joint including: Trapeziectomy with LRTI, Simple Trapeziectomy, Suspensionplasty (suture vs. APL)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline vas to 3-months
Awards & highlights

Study Summary

This trial will help to determine if a shorter duration of immobilization following thumb CMC arthroplasty results in fewer negative impacts while still allowing for adequate healing.

Who is the study for?
This trial is for individuals over 40 years old who are having surgery for thumb osteoarthritis but haven't had previous surgeries on the thumb base. It's not suitable for those with inflammatory arthritis, hypermobility syndrome, or anyone needing additional procedures like carpal tunnel release.Check my eligibility
What is being tested?
The study tests two different lengths of time that a patient's thumb is kept immobile after surgery: one group will have their thumb immobilized for 2 weeks and another group for 6 weeks. The goal is to see which duration is better for recovery.See study design
What are the potential side effects?
Potential side effects from prolonged immobilization may include stiffness in the thumb joint, contracture (tightening of muscles), and possibly a delay in returning to full hand function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 40 years old or older.
Select...
I am having surgery on my thumb joint.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline vas to 3-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline vas to 3-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
Quick Disabilities of Arm, Shoulder, and Hand (quickDASH) Questionnaire scores
Secondary outcome measures
Upper Extremity
Visual Analog Scale (VAS) Pain scale

Trial Design

2Treatment groups
Active Control
Group I: 2 weeks of immobilizationActive Control1 Intervention
Subjects randomized to this arm will be rigidly immobilized in a plaster postoperative thumb spica splint for 2 weeks following their thumb CMC arthroplasty
Group II: 6 weeks of immobilizationActive Control1 Intervention
Subjects randomized to this arm will be rigidly immobilized in a plaster postoperative thumb spica splint, transitioned to cast, for a total of 6 weeks following their thumb CMC arthroplasty

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,701 Total Patients Enrolled
2 Trials studying Osteoarthritis
348 Patients Enrolled for Osteoarthritis
Jennifer Wolf, MDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
128 Total Patients Enrolled

Media Library

Arthroplasty of the Carpometacarpal Joint of the Thumb (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04828954 — N/A
Osteoarthritis Research Study Groups: 2 weeks of immobilization, 6 weeks of immobilization
Osteoarthritis Clinical Trial 2023: Arthroplasty of the Carpometacarpal Joint of the Thumb Highlights & Side Effects. Trial Name: NCT04828954 — N/A
Arthroplasty of the Carpometacarpal Joint of the Thumb (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04828954 — 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 open enrollment opportunities for this research project?

"As of now, clinicaltrials.gov is reporting that this particular trial has begun actively recruiting patients; the protocol was first published on April 19th 2021 and updated recently as of May 16th 2022."

Answered by AI

How many subjects are enrolled in this clinical research?

"Correct. Data hosted on clinicaltrials.gov shows that this medical study, which was originally posted on April 19th 2021, is actively recruiting participants. Approximately 90 people need to be recruited from a single trial site."

Answered by AI

Who else is applying?

What site did they apply to?
University of Chicago Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Have been to a preventative med doctor since 1999 with no help for pain over 10 injections.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Variable Immobilization Protocol for Arthroplasty of the Carpometacarpal Joint of the Thumb
2021. "Variable Immobilization Protocol for Arthroplasty of the Carpometacarpal Joint of the Thumb". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04828954.
~0 spots leftby May 2024
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