Syndesmotic Screw Vs Suture Button in Ankle Syndesmotic Diastasis
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Suture button fixation, Syndesmotic screw fixation.
- Who it may be relevant to
- Registry conditions: Syndesmotic Screw, Suture Button, Fixation, Ankle Syndesmotic Diastasis. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Study Between Syndesmotic Screw and Suture Button in Ankle Syndesmotic Diastasis
Overview
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.
Interventions
- Procedure Suture button fixation
Patients undergoing suture button fixation of syndesmosis injury. - Procedure Syndesmotic screw fixation
Patients undergoing syndesmotic screw fixation of syndesmosis injury.
Primary outcome measures
- The American Orthopaedic Foot and Ankle Society (AOFAS) [Time frame: 12 months postoperatively]
Secondary outcome measures (2)
- Degree of pain [Time frame: 12 months postoperatively]
- Ankle Range of motion (ROM) [Time frame: 12 months Postoperatively]
Eligibility criteria
Inclusion criteria
\- 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).
Exclusion criteria
\- 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).
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT06856980 · 36264MS76/6/23