- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07281469
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
Status
Not yet recruiting
Conditions
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
- Name: DR SUQLAIN ALI DR SUQLAIN ALI, MBBS FCPS
- Phone Number: 00923317949721
- Email: maliksaqlainali@gmail.com
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMSafdarMC
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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