Lateral Malleolus FracturesNCT07539922
Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle Fractures
A study testing Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle Fractures in people with Lateral Malleolus Fractures, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this prospective clinical trial study is to evaluate the clinical and radiological outcomes of treating non-union of the lateral malleolar ankle fractures by double compression screw fixation technique. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Malleolus Fractures
- What is being tested?
- Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle Fractures
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Both sexes.
- Transvers, non-united Weber type A Lateral Malleolar ankle fracture classification
- Non-union classified as atrophic, oligotrophic, or hypertrophic
- Radiologically confirmed non-union of distal fibular fracture (failure to unite after ≥ 6 months post-injury).
- Adequate bone stock on radiographs/CT suitable for screw fixation.
Who cannot join
- Active or previous osteomyelitis or local infection at the fracture site.
- Pathological fractures.
- Non-union with gross deformity or significant bone loss requiring complex reconstruction or bone transport
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, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag, Sohag Governorate, 82511
Muhammed Mahmood Muhammed Ahmed, +201144818977, Mohamed_m.ahmed_post@med.sohag.edu.eg
About this study
The aim of this prospective clinical trial study is to evaluate the clinical and radiological outcomes of treating non-union of the lateral malleolar ankle fractures by double compression screw fixation technique.
Read the detailed description
Fractures involving the lateral malleolar are among the most frequent injuries to the lower extremity, commonly occurring as part of ankle injuries due to twisting mechanisms, falls, or sports-related trauma . These fractures are typically treated effectively with conservative management in stable cases or operative fixation in unstable or displaced patterns. Internal fixation using plate and screw constructs remains the gold standard for displaced fractures, especially when associated with syndesmotic injury or disruption of the ankle mortise . Despite favorable outcomes, complications such as delayed union and nonunion, although relatively rare in the lateral malleolar fractures, can present significant management dilemmas. Non-union refers to the failure of a fracture to heal within an expected time frame and may be classified as hypertrophic (due to inadequate stability) ,atrophic (due to impaired biological activity), oligotrophic or septic non-union .
Risk factors contributing to non-union include inadequate fixation, poor vascularity, infection, smoking, diabetes, and patient non-compliance. When nonunion occurs at the lateral malleolar, it may result in persistent lateral ankle pain, instability, mechanical dysfunction, altered gait mechanics, and decreased quality of life .
The lateral malleolus plays a critical role in maintaining ankle stability and congruity. It serves as a lateral buttress, resisting talar shift and external rotation.
A non-united fibular fracture, especially in the distal third, can disrupt this alignment and compromise the overall biomechanics of the ankle joint . Therefore, surgical intervention is typically warranted in symptomatic non-unions to restore anatomical alignment, re-establish joint stability, and facilitate bony healing Various surgical options have been described for the treatment of lateral malleolar non-unions, including open reduction and internal fixation (ORIF) with plate constructs, bone grafting (autograft or allograft), intramedullary fixation, and, in some cases, external fixation. While plate fixation provides strong stability, it is associated with soft tissue irritation, increased surgical exposure, and potential wound complications, especially in the distal fibula where soft tissue coverage is limited .
In contrast, intramedullary or percutaneous fixation methods, such as the use of compression screws, offer a less invasive approach with reduced morbidity and satisfactory biomechanical outcomes in selected cases . The double compression screw technique provides rigid fixation with minimal hardware prominence and soft tissue disruption. By achieving interfragmentary compression along the fracture line, this method enhances stability and promotes biological healing, making it a suitable option for treating select cases of fibular non-union, particularly in non-comminuted fractures and in patients where soft tissue preservation is essential .
The purpose of this study will be to evaluate the clinical and radiological outcomes of treating non-union of the lateral malleolar fracture by double compression screw fixation technique.
- Conditions
- Lateral Malleolus Fractures
- Being tested
- Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle Fractures
- Keywords
- Non union Lateral Malleolus fracture, Double Compression Screw Fixation, Lateral Malleolar Ankle Fractures
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle FracturesProcedure or surgery
A lateral approach to the distal fibula will be made, centered over the non-union site. Dissection will be carried down through the subcutaneous tissue with care to protect the superficial peroneal nerve. Minimal soft tissue striping will be performed to preserve vascularity. The fibular non-union site will be exposed, and fibrous tissue interposed at the fracture line will be carefully debrided using curettes and rongeurs, the sclerotic edges of the non-union will be freshened until punctate bleeding bone (the "Paprika sign") will be observed.
The fracture will be anatomically reduced under direct visualization and temporarily held with reduction clamps, under fluoroscopic guidance, insert appropriate guide wire then 6.5 mm Double compression screws will be inserted across the fracture site in perpendicular orientation, from distal to proximal, traversing the non-union zone. Screw trajectory will be chosen to maximize bone purchase while avoiding joint penetration or screw collision.
| Study group | Role | What they receive |
|---|---|---|
| patient with symptomatic non-union of lateral malleolar ankle fractures | Experimental | Not described Receives: Procedure: Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle Fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
union of lateral malleolar fracture
Serial radiographs will be obtained at 2, 6, and 12 weeks postoperatively to assess union and screw position. Union will be confirmed by the presence of bridging trabeculae across the fracture site and resolution of fracture lines.
Measured: 12 weeks postoperative
Secondary outcomes (2)
absence of pain
Clinical signs of union included absence of pain, return to normal function, and full weight-bearing without assistance. Pain intensity will be assessed using visual analogue score (VAS) (0 represents no pain while ten represents the worst pain)
Measured: 12 weeks postoperative
foot function and range of motion
Foot function will be evaluated by foot and ankle ability measure (FAAM)
Measured: 12 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Feb 2026
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral 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
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Mahmood Muhammed Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539922
- Sponsor's protocol ID
- Soh-Med-26-1-6MS
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle Fractures
- ClinicalTrials.gov ID
- NCT07539922
- Acronym / sponsor ID
- Soh-Med-26-1-6MS
- Conditions
- Lateral Malleolus Fractures
- Keywords
- Non union Lateral Malleolus fracture, Double Compression Screw Fixation, Lateral Malleolar Ankle Fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 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.
The aim of this prospective clinical trial study is to evaluate the clinical and radiological outcomes of treating non-union of the lateral malleolar ankle fractures by double compression screw fixation technique.
Detailed description
Fractures involving the lateral malleolar are among the most frequent injuries to the lower extremity, commonly occurring as part of ankle injuries due to twisting mechanisms, falls, or sports-related trauma . These fractures are typically treated effectively with conservative management in stable cases or operative fixation in unstable or displaced patterns. Internal fixation using plate and screw constructs remains the gold standard for displaced fractures, especially when associated with syndesmotic injury or disruption of the ankle mortise . Despite favorable outcomes, complications such as delayed union and nonunion, although relatively rare in the lateral malleolar fractures, can present significant management dilemmas. Non-union refers to the failure of a fracture to heal within an expected time frame and may be classified as hypertrophic (due to inadequate stability) ,atrophic (due to impaired biological activity), oligotrophic or septic non-union .
Risk factors contributing to non-union include inadequate fixation, poor vascularity, infection, smoking, diabetes, and patient non-compliance. When nonunion occurs at the lateral malleolar, it may result in persistent lateral ankle pain, instability, mechanical dysfunction, altered gait mechanics, and decreased quality of life .
The lateral malleolus plays a critical role in maintaining ankle stability and congruity. It serves as a lateral buttress, resisting talar shift and external rotation.
A non-united fibular fracture, especially in the distal third, can disrupt this alignment and compromise the overall biomechanics of the ankle joint . Therefore, surgical intervention is typically warranted in symptomatic non-unions to restore anatomical alignment, re-establish joint stability, and facilitate bony healing Various surgical options have been described for the treatment of lateral malleolar non-unions, including open reduction and internal fixation (ORIF) with plate constructs, bone grafting (autograft or allograft), intramedullary fixation, and, in some cases, external fixation. While plate fixation provides strong stability, it is associated with soft tissue irritation, increased surgical exposure, and potential wound complications, especially in the distal fibula where soft tissue coverage is limited .
In contrast, intramedullary or percutaneous fixation methods, such as the use of compression screws, offer a less invasive approach with reduced morbidity and satisfactory biomechanical outcomes in selected cases . The double compression screw technique provides rigid fixation with minimal hardware prominence and soft tissue disruption. By achieving interfragmentary compression along the fracture line, this method enhances stability and promotes biological healing, making it a suitable option for treating select cases of fibular non-union, particularly in non-comminuted fractures and in patients where soft tissue preservation is essential .
The purpose of this study will be to evaluate the clinical and radiological outcomes of treating non-union of the lateral malleolar fracture by double compression screw fixation technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with symptomatic non-union of lateral malleolar ankle fractures | Experimental | Procedure: Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle Fractures |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age from 18 to 65 years.
- Both sexes.
- Transvers, non-united Weber type A Lateral Malleolar ankle fracture classification
- Non-union classified as atrophic, oligotrophic, or hypertrophic
- Radiologically confirmed non-union of distal fibular fracture (failure to unite after ≥ 6 months post-injury).
Key exclusion criteria (3 listed)
- Active or previous osteomyelitis or local infection at the fracture site.
- Pathological fractures.
- Non-union with gross deformity or significant bone loss requiring complex reconstruction or bone transport
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 |
|---|---|---|
| Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle FracturesA lateral approach to the distal fibula will be made, centered over the non-union site. Dissection will be carried down through the subcutaneous tissue with care to protect the superficial peroneal nerve. Minimal soft tissue striping will be performed to preserve vascularity. The fibular non-union site will be exposed, and fibrous tissue interposed at the fracture line will be carefully debrided using curettes and rongeurs, the sclerotic edges of the non-union will be freshened until punctate bleeding bone (the "Paprika sign") will be observed. The fracture will be anatomically reduced under direct visualization and temporarily held with reduction clamps, under fluoroscopic guidance, insert appropriate guide wire then 6.5 mm Double compression screws will be inserted across the fracture site in perpendicular orientation, from distal to proximal, traversing the non-union zone. Screw trajectory will be chosen to maximize bone purchase while avoiding joint penetration or screw collision. | Procedure or surgery | patient with symptomatic non-union of lateral malleolar ankle fractures |
Primary outcome
union of lateral malleolar fracture
Time frame: 12 weeks postoperative
Serial radiographs will be obtained at 2, 6, and 12 weeks postoperatively to assess union and screw position. Union will be confirmed by the presence of bridging trabeculae across the fracture site and resolution of fracture lines.
2 secondary outcomes
absence of pain
Time frame: 12 weeks postoperative
foot function and range of motion
Time frame: 12 weeks postoperative
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
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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 Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle Fractures in people with Lateral 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 6 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
union of lateral malleolar fracture (time frame: 12 weeks postoperative). 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.