Distal Radius FracturesNCT07523386
Comparative Study Between Cannulated Screws and K-wires in the Fixation of Distal Radius Fractures
A study testing Cannulated screw Fixation In Treatment Of Distal Radius in people with Distal Radius Fractures, run by Sohag University at 1 site in Egypt.
Trial summary
This comparative study aims to evaluate the clinical and radiological outcomes of cannulated screw fixation versus K-wire fixation in the treatment of distal radius fractures. Adult patients with distal radius fractures will be allocated to either cannulated screw fixation or K-wire fixation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Cannulated screw Fixation In Treatment Of Distal Radius
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Apr 2026to 23 Jan 2027
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged between 18_60years.
- Patients with displaced or unstable Distal Radius Fractures requiring surgical Fixation.
- Type A Extra articular Fractures.
- Patients fit for surgery and willing to participate in the study.
Who cannot join
- open distal Radius Fractures.
- Pathological Fractures.
- Previous Fractures or surgeries affecting the wrist.
- Associated neurovascular injury.
- polytrauma patient.
- Patients with severe osteoporotic or systemic condition affecting bone healing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Comparative Study Between Cannulated Screws and K-wires in the Treatment of Distal Radius Fractures
This comparative study aims to evaluate the clinical and radiological outcomes of cannulated screw fixation versus K-wire fixation in the treatment of distal radius fractures. Adult patients with distal radius fractures will be allocated to either cannulated screw fixation or K-wire fixation. The primary outcome measure will be functional outcome assessed using the DASH score, with secondary outcomes including radiographic parameters and complication rates.
Read the detailed description
Distal radius fractures are among the most common orthopedic injuries in adults. Various fixation techniques are used depending on fracture pattern and surgeon preference. Cannulated screw fixation and K-wire fixation are minimally invasive techniques commonly used in selected fracture types; however, there is ongoing debate regarding their comparative effectiveness in terms of functional recovery and complication rates.
This prospective comparative study will include patients diagnosed with distal radius fractures who meet the inclusion criteria. Participants will be allocated into two groups: Group A will undergo fixation using cannulated screws, and Group B will undergo fixation using K-wires. Patients will be followed for a period of 6 months postoperatively.
The primary outcome will be functional assessment using the DASH score at 6 months. Secondary outcomes will include radiographic parameters (radial height, radial inclination, and volar tilt), time to union, and postoperative complications.
- Conditions
- Distal Radius Fractures
- Being tested
- Cannulated screw Fixation In Treatment Of Distal Radius
- Keywords
- Distal Radius Fractures, Cannulated screws, Colles'
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannulated screw Fixation In Treatment Of Distal RadiusProcedure or surgery
Patients assigned to this group will undergo surgical fixation of distal radius fractures using cannulated screws. The procedure involves open reduction and internal fixation with appropriate screw placement under fluoroscopic guidance. Postoperative care includes standard immobilization, physiotherapy, and follow-up visits to assess functional recovery using the DASH score and radiographic alignment. Complications such as infection, malunion, or hardware failure will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| Cannulated Screw Fixation | Other | Arm 1: Cannulated Screw Fixation
Description:
Patients in this group will undergo surgical fixation of distal radius fractures using cannulated screws. Postoperative functional outcomes will be assessed using the DASH score at 6 months. Radiographic alignment (radial height, radial inclination, and volar tilt) and complication rates will also be recorded Receives: Procedure: Cannulated screw Fixation In Treatment Of Distal Radius |
| K-wire fixation | No intervention | Patients in this group will undergo surgical fixation of distal radius fractures using percutaneous K-wires. The procedure involves closed reduction followed by insertion of K-wires under fluoroscopic guidance. Postoperative care includes immobilization and physiotherapy. Functional outcomes will be assessed using the DASH score at 6 months, and radiographic alignment and complication rates will be monitored. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Radiological union
Number of patients achieving complete bone healing as assessed by serial X-rays (presence of bridging callus on 3 out of 4 cortices).
Unit of Measure: Number of Participants.
Measured: 6months postoperatively
Mean Hand Grip Strength
Measurement of the physical force of the hand using a calibrated Jamar hydraulic hand dynamometer. The average of three successive trials with the affected hand will be recorded.
Unit of Measure: Kilograms.
Measured: 6months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start22 Apr 2026 (estimated)
- Primary completion22 Jan 2027 (estimated)
- Study completion23 Jan 2027 (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.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Tammam, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523386
- Sponsor's protocol ID
- Soh-Med-26-3-2MS
- Status last verified
- Mar 2026
- First submitted
- 5 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Cannulated Screws and K-wires in the Treatment of Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT07523386
- Acronym / sponsor ID
- Soh-Med-26-3-2MS
- Conditions
- Distal Radius Fractures
- Keywords
- Distal Radius Fractures, Cannulated screws, Colles'
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 22 Apr 2026 (estimated)
- Primary completion
- 22 Jan 2027 (estimated)
- Study completion
- 23 Jan 2027 (estimated)
- First posted
- 13 Apr 2026 (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 comparative study aims to evaluate the clinical and radiological outcomes of cannulated screw fixation versus K-wire fixation in the treatment of distal radius fractures. Adult patients with distal radius fractures will be allocated to either cannulated screw fixation or K-wire fixation. The primary outcome measure will be functional outcome assessed using the DASH score, with secondary outcomes including radiographic parameters and complication rates.
Detailed description
Distal radius fractures are among the most common orthopedic injuries in adults. Various fixation techniques are used depending on fracture pattern and surgeon preference. Cannulated screw fixation and K-wire fixation are minimally invasive techniques commonly used in selected fracture types; however, there is ongoing debate regarding their comparative effectiveness in terms of functional recovery and complication rates.
This prospective comparative study will include patients diagnosed with distal radius fractures who meet the inclusion criteria. Participants will be allocated into two groups: Group A will undergo fixation using cannulated screws, and Group B will undergo fixation using K-wires. Patients will be followed for a period of 6 months postoperatively.
The primary outcome will be functional assessment using the DASH score at 6 months. Secondary outcomes will include radiographic parameters (radial height, radial inclination, and volar tilt), time to union, and postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannulated Screw Fixation | Other | Procedure: Cannulated screw Fixation In Treatment Of Distal RadiusArm 1: Cannulated Screw Fixation Description: Patients in this group will undergo surgical fixation of distal radius fractures using cannulated screws. Postoperative functional outcomes will be assessed using the DASH score at 6 months. Radiographic alignment (radial height, radial inclination, and volar tilt) and complication rates will also be recorded |
| K-wire fixation | No intervention | –Patients in this group will undergo surgical fixation of distal radius fractures using percutaneous K-wires. The procedure involves closed reduction followed by insertion of K-wires under fluoroscopic guidance. Postoperative care includes immobilization and physiotherapy. Functional outcomes will be assessed using the DASH score at 6 months, and radiographic alignment and complication rates will be monitored. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged between 18_60years.
- Patients with displaced or unstable Distal Radius Fractures requiring surgical Fixation.
- Type A Extra articular Fractures.
- Patients fit for surgery and willing to participate in the study.
Key exclusion criteria (6 listed)
- open distal Radius Fractures.
- Pathological Fractures.
- Previous Fractures or surgeries affecting the wrist.
- Associated neurovascular injury.
- polytrauma patient.
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 |
|---|---|---|
| Cannulated screw Fixation In Treatment Of Distal RadiusPatients assigned to this group will undergo surgical fixation of distal radius fractures using cannulated screws. The procedure involves open reduction and internal fixation with appropriate screw placement under fluoroscopic guidance. Postoperative care includes standard immobilization, physiotherapy, and follow-up visits to assess functional recovery using the DASH score and radiographic alignment. Complications such as infection, malunion, or hardware failure will be monitored. | Procedure or surgery | Cannulated Screw Fixation |
Primary outcome
1. Radiological union
Time frame: 6months postoperatively
Number of patients achieving complete bone healing as assessed by serial X-rays (presence of bridging callus on 3 out of 4 cortices). Unit of Measure: Number of Participants.
Mean Hand Grip Strength
Time frame: 6months postoperatively
Measurement of the physical force of the hand using a calibrated Jamar hydraulic hand dynamometer. The average of three successive trials with the affected hand will be recorded. Unit of Measure: Kilograms.
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 20 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannulated screw Fixation In Treatment Of Distal Radius in people with Distal Radius Fractures, run by Sohag University at 1 site in Egypt.
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 4 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. 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 Egypt. 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 Ahmed Mahmoud Tammam, Practiciant (01020745267, ahmd.tamam2425@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Radiological union (time frame: 6months postoperatively). The study lists 2 primary outcomes in all. 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 20 Apr 2026.