Anterograde Screw Fixation for Medial Malleolus FracturesNCT07148375
Fixation of Medial Malleolar Fractures .
A study testing Anterograde screws for medial Malleolus fractures in people with Anterograde Screw Fixation for Medial Malleolus Fractures, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the functional and radiological outcomes following of fixation of Herscovici type B and type C medial malleolar fractures with anterograde headless screws. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Anterograde Screw Fixation for Medial Malleolus Fractures
- What is being tested?
- Anterograde screws for medial Malleolus fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Skeletally Immature . Compound fractures ( Grade II,III). Pathological fractures. Diabetic patients .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterograde Headless Screw Fixation For Treatment Of Medial Malleolar Fractures .
The aim of this study is to evaluate the functional and radiological outcomes following of fixation of Herscovici type B and type C medial malleolar fractures with anterograde headless screws.
Read the detailed description
Ankle fracture is one of the most common orthopaedic injuries[1]. Medial Malleolus fractures are Classified According to Herscovici classification Using the anteroposterior (AP) radiograph, he described type A fractures as avulsions of the tip of the malleolus, type B occurring between the tip and the level of the tibial plafond, type C at the level of the plafond, and type D extending vertically above the plafond [2].
The aim of operative treatment in ankle fractures is to provide stable internal fixation and allow early movement . Several fixation techniques had been described for the anatomic reduction of fractures, including Kirschner wires (K-wire), tension band method, fixation with suture anchors, bioabsorbable screw fixation, a FiberWire loop with a tension band, and screw fixation[3].
In addition to these techniques, fixation with anterograde screws can also be used for medial malleolar fixation. Given that with time the size of the fractured distal fragment in a medial malleolar fracture is insufficient for retrograde fixation as ln Herscovici type B and type C[4].
Screws are commonly used to fix medial malleolus fractures , offering advantages like good compression and stability[5]. the advantage of the anterograde headless screw fixation technique over the other techniques is that less dissection of the deltoid ligament is required during fixation , no need for screws removal , less soft tissue irritation and less discomfort [6].
- Being tested
- Anterograde screws for medial Malleolus fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterograde screws for medial Malleolus fracturesProcedure or surgery
Fixation of medial Malleolus fracures by anterograde headless screws
| Study group | Role | What they receive |
|---|---|---|
| Any patient with medial Malleolus fracture | Experimental | Anterograde herbert screws for fixation of medial Malleolus fractures Receives: Procedure: Anterograde screws for medial Malleolus fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterograde Headless Screw Fixation for Treatment of Medial Malleolar Fractures .
Ankle fracture is one of the most common orthopaedic injuries[1]. Medial Malleolus fractures are Classified According to Herscovici classification Using the anteroposterior (AP) radiograph, he described type A fractures as avulsions of the tip of the malleolus, type B occurring between the tip and the level of the tibial plafond, type C at the level of the plafond, and type D extending vertically above the plafond [2].
The aim of operative treatment in ankle fractures is to provide stable internal fixation and allow early movement . Several fixation techniques had been described for the anatomic reduction of fractures, including Kirschner wires (K-wire), tension band method, fixation with suture anchors, bioabsorbable screw fixation, a FiberWire loop with a tension band, and screw fixation[3].
In addition to these techniques, fixation with anterograde screws can also be used for medial malleolar fixation. Given that with time the size of the fractured distal fragment in a media
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterograde Screw Fixation for Medial Malleolus 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
- Not applicable
- Intervention model
- Single group
- Model description
- The aim of this study is to evaluate the functional and radiological outcomes following of fixation of Herscovici type B and type C medial malleolar fractures with anterograde headless screws.
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal Abdelhakam, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148375
- Sponsor's protocol ID
- Soh-Med--25-8-1MS
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 29 Aug 2025
- 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 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterograde Headless Screw Fixation For Treatment Of Medial Malleolar Fractures .
- ClinicalTrials.gov ID
- NCT07148375
- Acronym / sponsor ID
- Soh-Med--25-8-1MS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 29 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.
The aim of this study is to evaluate the functional and radiological outcomes following of fixation of Herscovici type B and type C medial malleolar fractures with anterograde headless screws.
Detailed description
Ankle fracture is one of the most common orthopaedic injuries[1]. Medial Malleolus fractures are Classified According to Herscovici classification Using the anteroposterior (AP) radiograph, he described type A fractures as avulsions of the tip of the malleolus, type B occurring between the tip and the level of the tibial plafond, type C at the level of the plafond, and type D extending vertically above the plafond [2].
The aim of operative treatment in ankle fractures is to provide stable internal fixation and allow early movement . Several fixation techniques had been described for the anatomic reduction of fractures, including Kirschner wires (K-wire), tension band method, fixation with suture anchors, bioabsorbable screw fixation, a FiberWire loop with a tension band, and screw fixation[3].
In addition to these techniques, fixation with anterograde screws can also be used for medial malleolar fixation. Given that with time the size of the fractured distal fragment in a medial malleolar fracture is insufficient for retrograde fixation as ln Herscovici type B and type C[4].
Screws are commonly used to fix medial malleolus fractures , offering advantages like good compression and stability[5]. the advantage of the anterograde headless screw fixation technique over the other techniques is that less dissection of the deltoid ligament is required during fixation , no need for screws removal , less soft tissue irritation and less discomfort [6].
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 evaluate the functional and radiological outcomes following of fixation of Herscovici type B and type C medial malleolar fractures with anterograde headless screws.
| Arm | Type | Receives |
|---|---|---|
| Any patient with medial Malleolus fracture | Experimental | Procedure: Anterograde screws for medial Malleolus fracturesAnterograde herbert screws for fixation of medial Malleolus fractures |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
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 |
|---|---|---|
| Anterograde screws for medial Malleolus fracturesFixation of medial Malleolus fracures by anterograde headless screws | Procedure or surgery | Any patient with medial Malleolus fracture |
Primary outcome
Anterograde Headless Screw Fixation for Treatment of Medial Malleolar Fractures .
Time frame: 1 year
Ankle fracture is one of the most common orthopaedic injuries[1]. Medial Malleolus fractures are Classified According to Herscovici classification Using the anteroposterior (AP) radiograph, he described type A fractures as avulsions of the tip of the malleolus, type B occurring between the tip and the level of the tibial plafond, type C at the level of the plafond, and type D extending vertically above the plafond [2]. The aim of operative treatment in ankle fractures is to provide stable internal fixation and allow early movement . Several fixation techniques had been described for the anatomic reduction of fractures, including Kirschner wires (K-wire), tension band method, fixation with suture anchors, bioabsorbable screw fixation, a FiberWire loop with a tension band, and screw fixation[3]. In addition to these techniques, fixation with anterograde screws can also be used for medial malleolar fixation. Given that with time the size of the fractured distal fragment in a media
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 29 Aug 2025.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterograde screws for medial Malleolus fractures in people with Anterograde Screw Fixation for Medial Malleolus 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 0 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 29 Aug 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterograde Headless Screw Fixation for Treatment of Medial Malleolar Fractures . (time frame: 1 year). 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 29 Aug 2025.