Fixation of Lateral Malleolus in Ankle Fracture Type A&B by Plate Versus Intramedullary ScrewNCT07447336
Plate Versus Intramedullary Screw for Lateral Malleolus Fracture in Ankle Fracture Type A&B
A study testing Fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation in people with Fixation of Lateral Malleolus in Ankle Fracture Type A&B by Plate Versus Intramedullary Screw, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the short term : Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A\&B fracture ankle by plate versus intramedullary screw fixation Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fixation of Lateral Malleolus in Ankle Fracture Type A&B by Plate Versus Intramedullary Screw
- What is being tested?
- Fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Mar 2026to 5 Feb 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
- No healthy volunteers
- Adult
Who may be able to join
- Displaced , unstable lateral malleolar fractures Weber type A or B,
- either isolated or associated with medial or posterior malleolar fractures .
- Age group : [18_60 years old Patients]
- Male or female patient
Who cannot join
- 1. Associated syndesmotic injury
- 2open fractures 3. neuropathic disorders 4. paralytic disorders
- 5 Osteoporotic fractures 6. Patients with uncontrolled diabetes
- 7 Comminuted fractures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Medecine ,Sohag University
Sohag
Ahmed Mohamed Hemdan, Principal investigator, +201140113008, ahmadmohdelrashedy@gmail.com
About this study
Official title: Fixation of Lateral Malleolus in Danis_Weber A&B Ankle Fracture by Plate Versus Intramedullary Screw: A Comparative Study
The aim of this study is to compare the short term :
Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A\&B fracture ankle by plate versus intramedullary screw fixation
Read the detailed description
The aim of this study is to compare the short term :
Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A\&B fracture ankle by plate versus intramedullary screw fixation Study will occur at Orthopaedics and Traumatology department Sohag University Hospitals .Study will be done on about 52 participants selected randomly
- Conditions
- Fixation of Lateral Malleolus in Ankle Fracture Type A&B by Plate Versus Intramedullary Screw
- Being tested
- Fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation
- Keywords
- Lateral malleolus,type A&B ,plate,intramedullary screw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixationProcedure or surgery
under spinal anaesthesia. A suitable broad_spectrum antibiotic will be given with induction of anaesthesia. Patients will be positioned supine on a standard radiolucent operation table, under image intensifier guidance. A pneumatic tourniquet will be placed on the thigh and inflated .
Plate fixation group:
A straight incision made over the lateral malleolus . Then, blunt dissection through subcutaneous fat made to avoid injury to the superficial peroneal nerve. The periosteum dissected away to allow clean inspection of the fracture fragments. After the fracture reduced, plate applied to the lateral side of the lateral malleolus and held to the bone by a plate holder. The plate secured to the bone by screws above the fracture site and below it . Wounds then closed in layers before adding a sterile gauze dressing.
Intramedullary Screw group:
Under image intensifier guidance, closed reduction achieved by inverting and internally rotating the foot
| Study group | Role | What they receive |
|---|---|---|
| Group (A) : plate fixation for lateral malleolus fracture | Active comparator | fixation of lateral malleolar fracture in Danis_Weber_A\&B fracture ankle by plate(Group A) versus intramedullary screw fixation (Group B) Receives: Procedure: Fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the short term : Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation
compare the short term : Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A\&B fracture ankle by ORIF and plate fixation versus intramedullary screw fixation .Study will occur at Orthopaedics and Traumatology department Sohag University Hospitals .Study will be done on about 52 participants Functional outcome evaluated by Manchester_Oxford Foot Questionnaire(MOXFQ) scoring system: comprises three dimensions (pain, standing/walking, social interaction ) and also by VAS(Visual Analogue score)is a 10-cm (
) straight line used to measure subjective intensity of pain, fatigue, or mood, with 0 representing "no pain" and 10 or 100 representing "worst imaginable pain" American Orthopaedic Foot and Ankle Society (AOFAS) score is a 100-point clinical rating system (0-100, with higher being better) designed to evaluate pain (40 pts), function (50 pts), and alignment (10 pts) for foot and ankle
Measured: 4months,6months,9months,1year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start5 Mar 2026 (estimated)
- Primary completion5 Nov 2026 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fixation of Lateral Malleolus in Ankle Fracture Type A&B by Plate Versus Intramedullary ScrewStudies 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
- Model description
- The aim of this study is to compare the short term : Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis\_Weber\_A\&B fracture ankle by plate(Group A) and another group intramedullary screw fixation (Group B) Study will occur at Orthopaedics and Traumatology department Sohag University Hospitals .Study will be done on about 52 participants selected randomly
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Hemdan, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447336
- Sponsor's protocol ID
- Soh_Med_26_2_2MS
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixation of Lateral Malleolus in Danis_Weber A&B Ankle Fracture by Plate Versus Intramedullary Screw: A Comparative Study
- ClinicalTrials.gov ID
- NCT07447336
- Acronym / sponsor ID
- Soh_Med_26_2_2MS
- Conditions
- Fixation of Lateral Malleolus in Ankle Fracture Type A&B by Plate Versus Intramedullary Screw
- Keywords
- Lateral malleolus,type A&B ,plate,intramedullary screw
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 5 Mar 2026 (estimated)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 3 Mar 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.
The aim of this study is to compare the short term :
Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A\&B fracture ankle by plate versus intramedullary screw fixation
Detailed description
The aim of this study is to compare the short term :
Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A\&B fracture ankle by plate versus intramedullary screw fixation Study will occur at Orthopaedics and Traumatology department Sohag University Hospitals .Study will be done on about 52 participants selected randomly
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The aim of this study is to compare the short term : Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A\&B fracture ankle by plate(Group A) and another group intramedullary screw fixation (Group B) Study will occur at Orthopaedics and Traumatology department Sohag University Hospitals .Study will be done on about 52 participants selected randomly
| Arm | Type | Receives |
|---|---|---|
| Group (A) : plate fixation for lateral malleolus fracture | Active comparator | Procedure: Fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixationfixation of lateral malleolar fracture in Danis_Weber_A\&B fracture ankle by plate(Group A) versus intramedullary screw fixation (Group B) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Displaced , unstable lateral malleolar fractures Weber type A or B,
- either isolated or associated with medial or posterior malleolar fractures .
- Age group : [18_60 years old Patients]
- Male or female patient
Key exclusion criteria (4 listed)
- 1. Associated syndesmotic injury
- 2open fractures 3. neuropathic disorders 4. paralytic disorders
- 5 Osteoporotic fractures 6. Patients with uncontrolled diabetes
- 7 Comminuted fractures
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 |
|---|---|---|
| Fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixationunder spinal anaesthesia. A suitable broad_spectrum antibiotic will be given with induction of anaesthesia. Patients will be positioned supine on a standard radiolucent operation table, under image intensifier guidance. A pneumatic tourniquet will be placed on the thigh and inflated . Plate fixation group: A straight incision made over the lateral malleolus . Then, blunt dissection through subcutaneous fat made to avoid injury to the superficial peroneal nerve. The periosteum dissected away to allow clean inspection of the fracture fragments. After the fracture reduced, plate applied to the lateral side of the lateral malleolus and held to the bone by a plate holder. The plate secured to the bone by screws above the fracture site and below it . Wounds then closed in layers before adding a sterile gauze dressing. Intramedullary Screw group: Under image intensifier guidance, closed reduction achieved by inverting and internally rotating the foot | Procedure or surgery | Group (A) : plate fixation for lateral malleolus fracture |
Primary outcome
compare the short term : Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation
Time frame: 4months,6months,9months,1year after treatment
compare the short term : Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A\&B fracture ankle by ORIF and plate fixation versus intramedullary screw fixation .Study will occur at Orthopaedics and Traumatology department Sohag University Hospitals .Study will be done on about 52 participants Functional outcome evaluated by Manchester_Oxford Foot Questionnaire(MOXFQ) scoring system: comprises three dimensions (pain, standing/walking, social interaction ) and also by VAS(Visual Analogue score)is a 10-cm ( ) straight line used to measure subjective intensity of pain, fatigue, or mood, with 0 representing "no pain" and 10 or 100 representing "worst imaginable pain" American Orthopaedic Foot and Ankle Society (AOFAS) score is a 100-point clinical rating system (0-100, with higher being better) designed to evaluate pain (40 pts), function (50 pts), and alignment (10 pts) for foot and ankle
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 11 Mar 2026.
- Individual participant dataSharing planned: No
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 Fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation in people with Fixation of Lateral Malleolus in Ankle Fracture Type A&B by Plate Versus Intramedullary Screw, 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 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 11 Mar 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 Mohamed Hemdan, Principal investigator (+201140113008, ahmadmohdelrashedy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the short term : Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation (time frame: 4months,6months,9months,1year after treatment). 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 11 Mar 2026.