Distal Radius FracturesNCT07108543
Antegrade Versus Retrograde Cross K-Wire In Distal Radius Fracture
A study testing Antegrade versus retrograde cross k-wire in people with Distal Radius Fractures, run by Sohag University.
Trial summary
This study aims to compare the clinical and radiological outcomes of distal radius fractures treated with cross K-wire fixation using the antegrade versus retrograde technique. Adult patients with extra-articular distal radius fractures will be randomly assigned to one of the two surgical approaches. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Antegrade versus retrograde cross k-wire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Feb 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with extra-articular distal radius fractures. Fractures classified as Frykmann type 1 and type 2. Patients aged 18 years and above.
Who cannot join
- Skeletally immature patient.
- Intra-articular distal radius fractures.
- Communited fractures.
- Open fractures or fractures with neurovascular compromise.
- Patients with fractures requiring surgical interventions other than K-wire fixation.
- Patients with a history of infection or other conditions impair wound healing.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Elshazly S Mousa, professer contact
About this study
Official title: Antegrade Versus Retrograde Cross K-Wire In Distal Radius Fracture; A Comparative Study
This study aims to compare the clinical and radiological outcomes of distal radius fractures treated with cross K-wire fixation using the antegrade versus retrograde technique. Adult patients with extra-articular distal radius fractures will be randomly assigned to one of the two surgical approaches. The primary outcomes include fracture stability, functional recovery, and complication rates. The study is designed as a prospective, randomized controlled trial conducted at sohag university
- Conditions
- Distal Radius Fractures
- Being tested
- Antegrade versus retrograde cross k-wire
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antegrade versus retrograde cross k-wireProcedure or surgery
> Closed reduction of distal radius fracture followed by percutaneous insertion of two or more K-wires in an antegrade direction (from proximal to distal), crossing the fracture site under fluoroscopic guidance. The wires are introduced from the radial metaphysis and directed distally to stabilize the fracture.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Title: Antegrade K-wire Fixation | Experimental | participants in this group will undergo antegrade percutaneous cross K-wire fixation for distal radius fractures. K-wires will be inserted from proximal to distal direction under fluoroscopic guidance, following closed reduction Receives: Procedure: Antegrade versus retrograde cross k-wire |
| Arm 2 Title: Retrograde K-wire Fixation | Experimental | Participants in this group will undergo retrograde percutaneous cross K-wire fixation for distal radius fractures. K-wires will be inserted from distal to proximal direction under fluoroscopic guidance, following closed reduction Receives: Procedure: Antegrade versus retrograde cross k-wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological union of distal radius fracture
Radiographic healing will be assessed using standard X-rays to evaluate union status. Radiographs will be reviewed for signs of cortical continuity and absence of fracture lines
Measured: At 6 weeks, 3 months, and 6 months postoperatively
Secondary outcomes (2)
Functional outcome using DASH score
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to assess upper limb function
Measured: At 6 weeks, 3 months, and 6 months postoperatively
Pain level using Visual Analog Scale (VAS)
Pain will be evaluated using the Visual Analog Scale (0-10), with 0 indicating no pain and 10 indicating worst pain
Measured: At 1 week, 6 weeks, 3 months, and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- A randomized controlled trial using a parallel assignment model. Participants will be randomly assigned to one of two groups: Group A will undergo cross K-wire fixation using the antegrade technique, and Group B will undergo the retrograde technique. Outcomes will be compared between the two groups.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montasser Talaat Omar, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108543
- Sponsor's protocol ID
- Soh-Med-25--24MS
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antegrade Versus Retrograde Cross K-Wire In Distal Radius Fracture; A Comparative Study
- ClinicalTrials.gov ID
- NCT07108543
- Acronym / sponsor ID
- Soh-Med-25--24MS
- Conditions
- Distal Radius Fractures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 7 Aug 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.
This study aims to compare the clinical and radiological outcomes of distal radius fractures treated with cross K-wire fixation using the antegrade versus retrograde technique. Adult patients with extra-articular distal radius fractures will be randomly assigned to one of the two surgical approaches. The primary outcomes include fracture stability, functional recovery, and complication rates. The study is designed as a prospective, randomized controlled trial conducted at sohag university
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled trial using a parallel assignment model. Participants will be randomly assigned to one of two groups: Group A will undergo cross K-wire fixation using the antegrade technique, and Group B will undergo the retrograde technique. Outcomes will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Title: Antegrade K-wire Fixation | Experimental | Procedure: Antegrade versus retrograde cross k-wireparticipants in this group will undergo antegrade percutaneous cross K-wire fixation for distal radius fractures. K-wires will be inserted from proximal to distal direction under fluoroscopic guidance, following closed reduction |
| Arm 2 Title: Retrograde K-wire Fixation | Experimental | Procedure: Antegrade versus retrograde cross k-wireParticipants in this group will undergo retrograde percutaneous cross K-wire fixation for distal radius fractures. K-wires will be inserted from distal to proximal direction under fluoroscopic guidance, following closed reduction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with extra-articular distal radius fractures. Fractures classified as Frykmann type 1 and type 2. Patients aged 18 years and above.
Key exclusion criteria (6 listed)
- Skeletally immature patient.
- Intra-articular distal radius fractures.
- Communited fractures.
- Open fractures or fractures with neurovascular compromise.
- Patients with fractures requiring surgical interventions other than K-wire fixation.
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 |
|---|---|---|
| Antegrade versus retrograde cross k-wire> Closed reduction of distal radius fracture followed by percutaneous insertion of two or more K-wires in an antegrade direction (from proximal to distal), crossing the fracture site under fluoroscopic guidance. The wires are introduced from the radial metaphysis and directed distally to stabilize the fracture. | Procedure or surgery | Arm 1 Title: Antegrade K-wire Fixation, Arm 2 Title: Retrograde K-wire Fixation |
Primary outcome
Radiological union of distal radius fracture
Time frame: At 6 weeks, 3 months, and 6 months postoperatively
Radiographic healing will be assessed using standard X-rays to evaluate union status. Radiographs will be reviewed for signs of cortical continuity and absence of fracture lines
2 secondary outcomes
Functional outcome using DASH score
Time frame: At 6 weeks, 3 months, and 6 months postoperatively
Pain level using Visual Analog Scale (VAS)
Time frame: At 1 week, 6 weeks, 3 months, and 6 months postoperatively
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 7 Aug 2025.
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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.
Elshazly S Mousa, professer contact
Questions about this trial
What is this clinical trial studying?
A study testing Antegrade versus retrograde cross k-wire in people with Distal Radius Fractures, run by Sohag University.
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 1 inclusion and 6 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 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Montasser T Omar, resident (01550793173, montassertalaat3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological union of distal radius fracture (time frame: At 6 weeks, 3 months, and 6 months postoperatively). 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 7 Aug 2025.