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NCT04828954 · ClinicalTrials.gov registry record · NA

Variable Immobilization Protocol for Arthroplasty of the Carpometacarpal Joint of the Thumb

A NA study of Thumb Osteoarthritis, sponsored by University of Chicago.

Recruiting
Registry status
NA
Development phase
90
Enrollment target
1
Study location

NCT04828954 is a NA study of Thumb Osteoarthritis that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 90 participants, below the 104-participant average among 4 other Thumb Osteoarthritis trials with a reported enrollment target (13% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04828954, a NA study of Thumb Osteoarthritis, is actively recruiting participants, sponsored by University of Chicago.

RECRUITING
Registry status
NA
Development phase
90 participants
Enrollment target
1
Study location

Study Summary

Thumb carpometacarpal (CMC) osteoarthritis (OA) is common, seen frequently in middle-aged and elderly women. While a variety of surgical treatments have been described with none superior to any other, there is no consensus on the optimal duration of postoperative immobilization. Immobilization following surgery is critical for wound healing, pain control, and aid with activities of daily living in the early recovery period, though the duration of this must be weighed against the negative impacts of immobilization, such as stiffness, contracture, and delay in return to full function. The information gained in this study may allow hand surgeons to use an evidence-based postoperative rehabilitation protocol. Thus, our goal is to compare varying durations of postoperative immobilization after thumb CMC arthroplasty in a randomized trial design. Subjects will be randomized to treatment with non-removable thumb spica plaster postoperative splint immobilization for 2 weeks or non-removable thumb spica plaster splint transitioned to cast for a total of 6 weeks immobilization following base of thumb arthroplasty. Patient-reported outcome measures (PROs) and objective metrics will be tracked in the follow-up period.

Conditions Studied

Interventions

  • OTHER Immobilization for 2-weeks postoperative
  • OTHER Immobilization for 6-weeks postoperative

Study Locations (1)

Illinois

  • University of Chicago Medicine - Chicago

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2021-04-19
Est. Completion 2026-08-04
Phase NA

Sponsor

University of Chicago

796 total trials

What the Registry Record Tells You About NCT04828954

The ClinicalTrials.gov registry entry for NCT04828954 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 104-participant average among 4 other Thumb Osteoarthritis trials with a reported enrollment target (13% lower). The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Thumb Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which Immobilization for 2-weeks postoperative is the first listed.

NCT04828954 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT04828954 about?

NCT04828954 is a clinical study titled "Variable Immobilization Protocol for Arthroplasty of the Carpometacarpal Joint of the Thumb". Thumb carpometacarpal (CMC) osteoarthritis (OA) is common, seen frequently in middle-aged and elderly women. While a variety of surgical treatments have been described with none superior to any other, there is no consensus on the optimal duration of postoperative immobilization. Immobilization follo...

What is the current status of trial NCT04828954?

This trial is currently recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2021-04-19. Estimated completion is 2026-08-04.

What conditions does trial NCT04828954 study?

This clinical trial studies the following conditions: Thumb Osteoarthritis.

What interventions are being tested in trial NCT04828954?

The interventions under investigation include: Immobilization for 2-weeks postoperative (OTHER), Immobilization for 6-weeks postoperative (OTHER).

Who is sponsoring clinical trial NCT04828954?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04828954 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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