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

NCT07281469 | Not Yet Recruiting DMC

• 1 other identifier: KMSafdarMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colles' Fracture

Outcome Measures

Primary Outcomes (1)

• Garland and werely score

  The Gartland and Werley scoring system (range 0-52) evaluates functional outcomes after distal radius fracture. Lower scores indicate better outcomes

  3 months

Study Arms (2)

Closed Reduction and Plaster of Paris Cast Application

ACTIVE COMPARATOR

Closed reduction followed by Plaster of Paris cast application

Procedure: Closed reduction and fracture manipulation and plaster of Paris application in group A

Closed Reduction with Percutaneous K-Wire Fixation and Plaster of Paris Cast Application

ACTIVE COMPARATOR

Closed Reduction With K-Wire Fixation and POP Cast Closed reduction followed by percutaneous K-wire fixation and Plaster of Paris cast application

Procedure: closed reduction and Percutaneous K-wire fixation and plaster of application is applied in group B

Interventions

Closed reduction and fracture manipulation and plaster of Paris application in group A PROCEDURE

Closed reduction and manipulation of fracture and application of plaster of Paris in group A

Closed Reduction and Plaster of Paris Cast Application

closed reduction and Percutaneous K-wire fixation and plaster of application is applied in group B PROCEDURE

Group A Participant treated with the closed reduction and manipulation and plaster of paris application is applied for colles fracture.

Closed Reduction with Percutaneous K-Wire Fixation and Plaster of Paris Cast Application

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 60 years
• Both genders
• Closed Colles' fracture
• Injury less than 1 week old
• Provided informed consent

You may not qualify if:

• Open fracture
• Fracture with neurovascular injury
• Medically unfit for surgery
• Contraindication noted by orthopedic surgeon or anesthetist

Sponsors & Collaborators

• Khawaja Muhammad Safdar Medical College: lead

Study Sites (1)

Khawaja Muhammad Safdar Medical College Sialkot

Sialkot, Punjab Province, 51310, Pakistan

Location

MeSH Terms

Conditions

Colles' Fracture

Condition Hierarchy (Ancestors)

Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Radius Fractures; Fractures, Bone

Central Study Contacts

DR SUQLAIN ALI DR SUQLAIN ALI, MBBS FCPS

CONTACT

00923317949721; maliksaqlainali@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Suqlain Ali post graduate resident

Model Details: There are two groups in the study each group contains 30patients ,group A apply plaster of Paris for colles fracture and group B patients treated with k wires and plaster of Paris

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 15, 2025
• Study Start: December 2, 2025
• Primary Completion: January 18, 2026
• Study Completion: January 30, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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
• 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

Locations

PA (1)