Tanta University
Tanta, El-Gharbia, 31527, Egypt
NCT Number: NCT06856980
The aim of this study is to compare suture-button versus syndesmotic screw in the treatment of distal tibiofibular syndesmotic injury.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Interventional
Not applicable
Tanta, El-Gharbia, 31527, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient-related exclusion factors included:
Injury-related exclusion factors included:
Patients undergoing suture button fixation of syndesmosis injury.
Other names: Group A
Patients undergoing syndesmotic screw fixation of syndesmosis injury.
Other names: Group B
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).
Time frame: 12 months postoperatively
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.
Time frame: 12 months Postoperatively
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
Contact information is provided by the study sponsor or research team.
Tanta University
Other
Comparative Study Between Syndesmotic Screw and Suture Button in Ankle Syndesmotic Diastasis
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