The Wrist-Free Study - Comparing Traditional Above Elbow Casts to Ones That Free the Wrist

July 4, 2024 updated by: KK Women's and Children's Hospital

The Wrist-Free Study- A Randomized Controlled Trial Comparing Traditional Above Elbow Casts to Ones That Free the Wrist in Pediatric Supracondylar Humerus Fractures

This randomized controlled trial compares clinical outcomes, patient comfort and satisfaction of freeing the wrist in casts for supracondylar humerus fractures in children.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type I and Type IIa Supracondylar Humerus Fracture

Exclusion Criteria:

  • History of elbow injury
  • Polytrauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional
Participants in this group receive the existing treatment, which is a cast that terminates at the palmar bar.
Procedure: Traditional long arm cast
Current standard of care where the cast extends up to the palmar bar
Experimental: Modified
Participants in this group receive the experimental treatment, a cast that terminates at the wrist.
Procedure: Modified long arm cast
A shorter cast that frees the wrist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: 3-4 Weeks
Measured using QDASH
3-4 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications in healing
Time Frame: 3-4 Weeks
Observe for loss of reduction in fracture
3-4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Investigators

  • Principal Investigator: Kenneth PL Wong, FRCS, KK Women's and Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2023

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

July 4, 2024

First Submitted That Met QC Criteria

July 4, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 4, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KKWCHWristFree

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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