Comparison of Functional Outcomes of Closed Reduction With Cast Versus Closed Reduction With K-Wire Fixation in Colles' Fracture

December 1, 2025 updated by: Suqlain Ali, Khawaja Muhammad Safdar Medical College

Comparison of the Functional Outcomes of Closed Reduction and Plaster of Paris Application Versus Closed Reduction With K-Wire Fixation and Plaster of Paris Application in the Management of Colles' Fracture.

Colles' fracture is a common distal radius injury, often managed with closed reduction and Plaster of Paris (POP) casting. However, loss of alignment may occur with casting alone. Percutaneous K-wire fixation may improve fracture stability. This study aims to compare the functional outcomes of closed reduction with POP cast application versus closed reduction with K-wire fixation followed by POP cast application in the management of Colles' fractures.

Study Overview

Detailed Description

This randomized controlled trial evaluates two commonly used treatment methods for Colles' fractures. Sixty participants were randomized into two groups: closed reduction with POP cast application, and closed reduction with percutaneous K-wire fixation followed by POP cast application. Follow-up assessments were scheduled to evaluate functional outcomes using the Gartland and Werley scoring system over a three-month period.

Study Type

Interventional

Enrollment (Estimated)

60

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

    • Punjab Province
      • Sialkot, Punjab Province, Pakistan, 51310
        • Khawaja Muhammad Safdar Medical College Sialkot

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age 18 to 60 years

Both genders

Closed Colles' fracture

Injury less than 1 week old

Provided informed consent

Exclusion Criteria:

Open fracture

Fracture with neurovascular injury

Medically unfit for surgery

Contraindication noted by orthopedic surgeon or anesthetist

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Closed Reduction and Plaster of Paris Cast Application
Closed reduction followed by Plaster of Paris cast application
Closed reduction and manipulation of fracture and application of plaster of Paris in group A
Active Comparator: Closed Reduction with Percutaneous K-Wire Fixation and Plaster of Paris Cast Application
Closed Reduction With K-Wire Fixation and POP Cast Closed reduction followed by percutaneous K-wire fixation and Plaster of Paris cast application
Group A Participant treated with the closed reduction and manipulation and plaster of paris application is applied for colles fracture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Garland and werely score
Time Frame: 3 months
The Gartland and Werley scoring system (range 0-52) evaluates functional outcomes after distal radius fracture. Lower scores indicate better outcomes
3 months

Collaborators and Investigators

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

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 (Estimated)

December 2, 2025

Primary Completion (Estimated)

January 18, 2026

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie the results of the primary and secondary outcomes will be shared after de-identification. Shared data will include demographic variables, baseline characteristics, and outcome measures collected during the trial.

IPD Sharing Time Frame

IPD and supporting documents will be made available beginning 12 months after publication of the primary results. Data will remain available for a minimum of 5 years thereafter or until the end of the study's data-retention period, whichever occurs later

IPD Sharing Access Criteria

Access will be granted to qualified researchers affiliated with academic, nonprofit, or governmental institutions for the purpose of scientific inquiry and secondary analyses. Researchers must submit a data-access request including a brief proposal and statistical analysis plan. Upon approval, data will be shared through a secure, controlled-access data repository. Users will be required to sign a data use agreement prohibiting re-identification or unauthorized sharing of the data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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