Syndesmotic Screw Vs Suture Button in Ankle Syndesmotic Diastasis
NCT ID: NCT06856980
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
42 participants
INTERVENTIONAL
2025-03-15
2026-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Suture button fixation
Patients undergoing suture button fixation of syndesmosis injury
Suture button fixation
Patients undergoing suture button fixation of syndesmosis injury.
Syndesmotic screw fixation
Patients undergoing syndesmotic screw fixation of syndesmosis injury
Syndesmotic screw fixation
Patients undergoing syndesmotic screw fixation of syndesmosis injury.
Interventions
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Suture button fixation
Patients undergoing suture button fixation of syndesmosis injury.
Syndesmotic screw fixation
Patients undergoing syndesmotic screw fixation of syndesmosis injury.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* Skeletal immaturity.
* Previous ipsilateral ankle surgery.
* Non-ambulatory status before injury.
* Inability to comply with postoperative protocol (i.e., advanced dementia).
* 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).
18 Years
60 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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El-Sayed Sherif Soliman El-Gamasy
Resident of Orthopedic Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.
Locations
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Tanta University
Tanta, El-Gharbia, Egypt
Countries
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Central Contacts
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Other Identifiers
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36264MS76/6/23
Identifier Type: -
Identifier Source: org_study_id
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