Distal Ulna FractureNCT07440251
Evaluation of Dual Fixation of Distal Ulna Fractures by Flexible Intramedullary Nail and Mini Locked Plate 2.7 mm.
A study testing Dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mm in people with Distal Ulna Fracture, run by Sohag University at 1 site in Egypt.
Trial summary
Although isolated fixation methods, such as intramedullary nails or plate fixation, are commonly employed, certain fracture patterns-particularly comminuted, osteoporotic, or unstable fractures- represent a challenge to achieve stable fixation and restoring normal anatomy . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Ulna Fracture
- What is being tested?
- Dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2026to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Displaced distal ulna fractures either isolated or with associated distal radius fractures.
- Unstable distal ulna fractures
- Age group: [Adults aged 18 years and older].
Who cannot join
- Open fractures with severe soft tissue injury (Gustilo type III).
- Pathological fractures.
- Patients with systemic conditions affecting bone healing e.g. uncontrolled diabetes and severe osteoporosis.
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: Evaluation of Dual Fixation of Distal Ulna Fractures by Flexible Intramedullary Nail and Mini Locked Plate 2.7 mm
Although isolated fixation methods, such as intramedullary nails or plate fixation, are commonly employed, certain fracture patterns-particularly comminuted, osteoporotic, or unstable fractures- represent a challenge to achieve stable fixation and restoring normal anatomy .
Dual fixation, combining an intramedullary nail with a low-profile 2.7-mm mini locked plate, aims to capitalize on the strengths of both techniques-a concept known as "orthogonal or hybrid stabilization". This combined approach provides enhanced biomechanical stability, allows for early mobilization by sharing the mechanical load, and minimizes the risk of non-union or hardware failure. Studying the clinical and radiological outcomes of this dual fixation strategy is essential to establish its efficacy and safety in managing complex distal ulna fractures.
- Conditions
- Distal Ulna Fracture
- Being tested
- Dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mm
- Keywords
- Distal ulna fractures, Dual fixation
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mmProcedure or surgery
Evaluation of dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mm.
| Study group | Role | What they receive |
|---|---|---|
| Distal ulna fractures | Other | Not described Receives: Procedure: Dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 24 Weeks
Secondary outcomes (2)
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: 24 weeks
Range of Motion (ROM) of the affected joint (wrist)
Clinical measurement of the degree of movement in the joint (flexion, extension, pronation, and supination) using a standard goniometer.
Unit of Measure: Degrees.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start20 Feb 2026
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Ulna FractureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Ali Hamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440251
- Sponsor's protocol ID
- Soh-Med-26-2-1MS
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dual Fixation of Distal Ulna Fractures by Flexible Intramedullary Nail and Mini Locked Plate 2.7 mm
- ClinicalTrials.gov ID
- NCT07440251
- Acronym / sponsor ID
- Soh-Med-26-2-1MS
- Conditions
- Distal Ulna Fracture
- Keywords
- Distal ulna fractures, Dual fixation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 27 Feb 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.
Although isolated fixation methods, such as intramedullary nails or plate fixation, are commonly employed, certain fracture patterns-particularly comminuted, osteoporotic, or unstable fractures- represent a challenge to achieve stable fixation and restoring normal anatomy .
Dual fixation, combining an intramedullary nail with a low-profile 2.7-mm mini locked plate, aims to capitalize on the strengths of both techniques-a concept known as "orthogonal or hybrid stabilization". This combined approach provides enhanced biomechanical stability, allows for early mobilization by sharing the mechanical load, and minimizes the risk of non-union or hardware failure. Studying the clinical and radiological outcomes of this dual fixation strategy is essential to establish its efficacy and safety in managing complex distal ulna fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distal ulna fractures | Other | Procedure: Dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Displaced distal ulna fractures either isolated or with associated distal radius fractures.
- Unstable distal ulna fractures
- Age group: [Adults aged 18 years and older].
Key exclusion criteria (3 listed)
- Open fractures with severe soft tissue injury (Gustilo type III).
- Pathological fractures.
- Patients with systemic conditions affecting bone healing e.g. uncontrolled diabetes and severe osteoporosis.
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 |
|---|---|---|
| Dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mmEvaluation of dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mm. | Procedure or surgery | Distal ulna fractures |
Primary outcome
Radiological union
Time frame: 24 Weeks
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.
2 secondary outcomes
Mean Hand Grip Strength
Time frame: 24 weeks
Range of Motion (ROM) of the affected joint (wrist)
Time frame: 24 weeks
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 24 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Distal Ulna Fracture
RecruitingObservational study
EASY Algorithm Trial (Elbow Trauma Assessment Using Sonography in Children and Youth) Diagnostic Accuracy and Safety of Point-of-care Ultrasound as a Screening Tool for Suspected Elbow Fractures in Children Aged 5 to 15 Years: a Multicenter Prospective Cohort Study
Elbow Fractures, Distal Humerus 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 Dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mm in people with Distal Ulna Fracture, 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 3 inclusion and 3 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 24 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 Mostafa Ali Hamed (+201006850240, mostafaalihamed97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological union (time frame: 24 Weeks). 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 24 Apr 2026.