Colles' FractureNCT07281469
Comparison of Functional Outcomes of Closed Reduction With Cast Versus Closed Reduction With K-Wire Fixation in Colles' Fracture
A study testing Closed reduction and fracture manipulation and plaster of Paris application in group A and closed reduction and Percutaneous K-wire fixation and plaster of application is applied in group B in people with Colles' Fracture, run by Khawaja Muhammad Safdar Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Colles' Fracture
- What is being tested?
- Closed reduction and fracture manipulation and plaster of Paris application in group A and closed reduction and Percutaneous K-wire fixation and plaster of application is applied in group B
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Dec 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 years
- Both genders
- Closed Colles' fracture
- Injury less than 1 week old
- Provided informed consent
Who cannot join
- Open fracture
- Fracture with neurovascular injury
- Medically unfit for surgery
- Contraindication noted by orthopedic surgeon or anesthetist
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Khawaja Muhammad Safdar Medical College Sialkot
Sialkot, Punjab Province, 51310
About this study
Official title: 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.
Read the 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.
- Conditions
- Colles' Fracture
- Being tested
- Closed reduction and fracture manipulation and plaster of Paris application in group A, closed reduction and Percutaneous K-wire fixation and plaster of application is applied in group B
- Medical subject headings
- Colles' Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed reduction and fracture manipulation and plaster of Paris application in group AProcedure or surgery
Closed reduction and manipulation of fracture and application of plaster of Paris in group A
closed reduction and Percutaneous K-wire fixation and plaster of application is applied in group BProcedure or surgery
Group A Participant treated with the closed reduction and manipulation and plaster of paris application is applied for colles fracture.
| Study group | Role | What they receive |
|---|---|---|
| Closed Reduction and Plaster of Paris Cast Application | Active comparator | Closed reduction followed by Plaster of Paris cast application Receives: 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 Receives: Procedure: closed reduction and Percutaneous K-wire fixation and plaster of application is applied in group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start2 Dec 2025 (estimated)
- Primary completion18 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colles' FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khawaja Muhammad Safdar Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suqlain Ali, Khawaja Muhammad Safdar Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281469
- Sponsor's protocol ID
- KMSafdarMC
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07281469
- Acronym / sponsor ID
- KMSafdarMC
- Conditions
- Colles' Fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Khawaja Muhammad Safdar Medical CollegeUniversity, hospital or other
- Study start
- 2 Dec 2025 (estimated)
- Primary completion
- 18 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Closed Reduction and Plaster of Paris Cast Application | Active comparator | Procedure: Closed reduction and fracture manipulation and plaster of Paris application in group AClosed reduction followed by Plaster of Paris cast application |
| Closed Reduction with Percutaneous K-Wire Fixation and Plaster of Paris Cast Application | Active comparator | Procedure: closed reduction and Percutaneous K-wire fixation and plaster of application is applied in group BClosed Reduction With K-Wire Fixation and POP Cast Closed reduction followed by percutaneous K-wire fixation and Plaster of Paris cast application |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 60 years
- Both genders
- Closed Colles' fracture
- Injury less than 1 week old
- Provided informed consent
Key exclusion criteria (4 listed)
- Open fracture
- Fracture with neurovascular injury
- Medically unfit for surgery
- Contraindication noted by orthopedic surgeon or anesthetist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed reduction and fracture manipulation and plaster of Paris application in group AClosed reduction and manipulation of fracture and application of plaster of Paris in group A | Procedure or surgery | Closed Reduction and Plaster of Paris Cast Application |
| closed reduction and Percutaneous K-wire fixation and plaster of application is applied in group BGroup A Participant treated with the closed reduction and manipulation and plaster of paris application is applied for colles fracture. | Procedure or surgery | Closed Reduction with Percutaneous K-Wire Fixation and Plaster of Paris Cast Application |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Colles' Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Active, not recruitingPhase 4
Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
Distal Radius Fractures, Fracture Dislocation
Recruiting
Comparative Study Between Cannulated Screws and K-wires in the Fixation of Distal Radius Fractures
Distal Radius Fractures
Recruiting
Comparison of Kaltenborn Mobilization and Mobilization With Movement (MWM) in Wrist Hypomobility After Colle's Fracture
Colles Fracture, Hypomobility
Active, not recruiting
Unstable Distal Radius Fractures With Dorsal Dislocation in Patients Aged 18-64 Years. Volar Locking Plate (VLP) vs Closed Reduction and Percutaenous Pinning (CRPP).
Distal Radius Fractures, Wrist Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed reduction and fracture manipulation and plaster of Paris application in group A and closed reduction and Percutaneous K-wire fixation and plaster of application is applied in group B in people with Colles' Fracture, run by Khawaja Muhammad Safdar Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DR SUQLAIN ALI DR SUQLAIN ALI, MBBS FCPS (00923317949721, maliksaqlainali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Garland and werely score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.