Syndesmotic ScrewNCT06856980
Syndesmotic Screw Vs Suture Button in Ankle Syndesmotic Diastasis
A study testing Suture button fixation and Syndesmotic screw fixation in people with Syndesmotic Screw and Suture Button, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare suture-button versus syndesmotic screw in the treatment of distal tibiofibular syndesmotic injury. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Syndesmotic Screw, Suture Button, Fixation
- What is being tested?
- Suture button fixation and Syndesmotic screw fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2025to 1 Jan 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unstable unilateral syndesmotic injuries that was considered by the attending staff surgeon to require surgical fixation, including:
- Age : 18 - 60 years old.
- Closed or grade I open fractures are included.
- Isolated syndesmotic injury.
- associated lateral malleolus fracture with talar shift.
- Associated with Bimalleolar fractures.
- Associated with Trimalleolar fractures that did not require posterior fragment fixation (typically <25% of articular surface).
Who cannot join
- Exclusion criteria include patient and injury specific factors.
- Patient-related exclusion factors included:
- Skeletal immaturity.
- Previous ipsilateral ankle surgery.
- Non-ambulatory status before injury.
- Inability to comply with postoperative protocol (i.e., advanced dementia).
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- Medical unfit patients for surgery.
- Uncontrolled diabetes mellitus with charcot joint or peripheral neuropathy.
- Polytrauma patients.
- Injury-related exclusion factors included:
- Grade II or III open fractures
- Tibial plafond fractures
- Posterior malleolar fractures requiring fixation (typically >25% articular surface involved).
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: Comparative Study Between Syndesmotic Screw and Suture Button in Ankle Syndesmotic Diastasis
The aim of this study is to compare suture-button versus syndesmotic screw in the treatment of distal tibiofibular syndesmotic injury.
Read the detailed description
The term syndesmotic injury is used to describe a lesion of the ligaments that connect the distal fibula and the tibial notch surrounded on both sides by the anterior and posterior tibial tubercles, with or without an associated injury of the deltoid ligament.
Accuracy and maintenance of syndesmosis reduction are considered the key elements in the treatment of ankle fractures. Screw fixation is considered the gold standard treatment for an unstable syndesmosis injury.
Button and suture construction with a medial-lateral metallic button and suture system offers an alternative method for repairing the distal tibio-fibular joint. Suture-button design has been shown to maintain the reduction, facilitating physiologic stability of the ankle mortise. This may allow early physiological motion, leading to earlier ligament healing and potentially earlier loading, which may produce better clinical results. However, this system is more expensive than the screw method and it may gradually relax under weightbearing conditions. Therefore, whether this device is a suitable alternative, and how many devices are needed for adequate stability are not yet known.
- Being tested
- Suture button fixation, Syndesmotic screw fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture button fixationProcedure or surgery
Also called Group A
Patients undergoing suture button fixation of syndesmosis injury.
Syndesmotic screw fixationProcedure or surgery
Also called Group B
Patients undergoing syndesmotic screw fixation of syndesmosis injury.
| Study group | Role | What they receive |
|---|---|---|
| Suture button fixation | Experimental | Patients undergoing suture button fixation of syndesmosis injury Receives: Procedure: Suture button fixation |
| Syndesmotic screw fixation | Experimental | Patients undergoing syndesmotic screw fixation of syndesmosis injury Receives: Procedure: Syndesmotic screw fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The American Orthopaedic Foot and Ankle Society (AOFAS)
As an interpretation of the American Orthopaedic Foot and Ankle Society (AOFAS) score, excellent results with score between (95-100). Good results between (75-94). Fair results between (51-74). Poor results between (0-50).
Measured: 12 months postoperatively
Secondary outcomes (2)
Degree of pain
Degree of pain was assessed using an interpretation of visual analogue scale (VAS) score, No pain with score 0, mild pain with score between (1-3), moderate pain with score between (4-7) and severe pain with score between (8-10). VAS was assessed at 6 weeks, 6 months and 12 months postoperatively.
Measured: 12 months postoperatively
Ankle Range of motion (ROM)
Motion of the ankle occurs primarily in the sagittal plane, with plantar- and dorsiflexion occurring predominantly at the tibiotalar joint. Overall Ankle range of motion (ROM) in the sagittal plane of between 65 and 75°, moving from 10 to 20° of dorsiflexion through to 40-55° of plantarflexion.
Sagittal motion (flexion plus extension) Normal or mild restriction (30° or more) : 8 Moderate restriction (15°-29°) : 4 Severe restriction (less than 15°) : 0
Measured: 12 months Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start15 Mar 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syndesmotic ScrewStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El-Sayed Sherif Soliman El-Gamasy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856980
- Sponsor's protocol ID
- 36264MS76/6/23
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Syndesmotic Screw and Suture Button in Ankle Syndesmotic Diastasis
- ClinicalTrials.gov ID
- NCT06856980
- Acronym / sponsor ID
- 36264MS76/6/23
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 4 Mar 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 compare suture-button versus syndesmotic screw in the treatment of distal tibiofibular syndesmotic injury.
Detailed description
The term syndesmotic injury is used to describe a lesion of the ligaments that connect the distal fibula and the tibial notch surrounded on both sides by the anterior and posterior tibial tubercles, with or without an associated injury of the deltoid ligament.
Accuracy and maintenance of syndesmosis reduction are considered the key elements in the treatment of ankle fractures. Screw fixation is considered the gold standard treatment for an unstable syndesmosis injury.
Button and suture construction with a medial-lateral metallic button and suture system offers an alternative method for repairing the distal tibio-fibular joint. Suture-button design has been shown to maintain the reduction, facilitating physiologic stability of the ankle mortise. This may allow early physiological motion, leading to earlier ligament healing and potentially earlier loading, which may produce better clinical results. However, this system is more expensive than the screw method and it may gradually relax under weightbearing conditions. Therefore, whether this device is a suitable alternative, and how many devices are needed for adequate stability are not yet known.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suture button fixation | Experimental | Procedure: Suture button fixationPatients undergoing suture button fixation of syndesmosis injury |
| Syndesmotic screw fixation | Experimental | Procedure: Syndesmotic screw fixationPatients undergoing syndesmotic screw fixation of syndesmosis injury |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Unstable unilateral syndesmotic injuries that was considered by the attending staff surgeon to require surgical fixation, including:
- Age : 18 - 60 years old.
- Closed or grade I open fractures are included.
- Isolated syndesmotic injury.
- associated lateral malleolus fracture with talar shift.
Key exclusion criteria (13 listed)
- Exclusion criteria include patient and injury specific factors.
- Skeletal immaturity.
- Previous ipsilateral ankle surgery.
- Non-ambulatory status before injury.
- Inability to comply with postoperative protocol (i.e., advanced dementia).
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 |
|---|---|---|
| Suture button fixationAlso: Group APatients undergoing suture button fixation of syndesmosis injury. | Procedure or surgery | Suture button fixation |
| Syndesmotic screw fixationAlso: Group BPatients undergoing syndesmotic screw fixation of syndesmosis injury. | Procedure or surgery | Syndesmotic screw fixation |
Primary outcome
The American Orthopaedic Foot and Ankle Society (AOFAS)
Time frame: 12 months postoperatively
As an interpretation of the American Orthopaedic Foot and Ankle Society (AOFAS) score, excellent results with score between (95-100). Good results between (75-94). Fair results between (51-74). Poor results between (0-50).
2 secondary outcomes
Degree of pain
Time frame: 12 months postoperatively
Ankle Range of motion (ROM)
Time frame: 12 months Postoperatively
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 6 Mar 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Syndesmotic Screw
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RecruitingObservational study
Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
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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 Suture button fixation and Syndesmotic screw fixation in people with Syndesmotic Screw and Suture Button, run by Tanta 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 7 inclusion and 13 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 6 Mar 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?
Contact El-Sayed S El-Gamasy, MBBCh (002 01206220396, elsayed.sherif@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The American Orthopaedic Foot and Ankle Society (AOFAS) (time frame: 12 months postoperatively). 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 6 Mar 2025.