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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)

Must not have

Patients who have undergone prior surgical procedures on the thumb base

Patients with history of prior procedure at the base of thumb, or those with plan for concomitant carpal tunnel release or thumb metacarpophalangeal (MCP) arthrodesis, will be excluded. Concomitant carpal tunnel surgery may skew outcome surveys, and an arthrodesis procedure will warrant a longer length of immobilization following procedure.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline vas to 3-months

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am 40 years old or older.

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I am having surgery on my thumb joint.

Exclusion Criteria

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

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I have had surgery on the base of my thumb before.

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I have not had surgery at the base of my thumb or plan to have surgery for carpal tunnel or thumb joint fusion.

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I have been diagnosed with inflammatory arthritis.

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I am younger than 40 years old.

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I have been diagnosed with hypermobility syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline vas to 3-months

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

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

Primary study objectives

Quick Disabilities of Arm, Shoulder, and Hand (quickDASH) Questionnaire scores

Secondary study objectives

Upper Extremity

Visual Analog Scale (VAS) Pain scale

Awards & Highlights

No Placebo-Only Group

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

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

0 / 7Eligibility criteria met