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The aim of this study is to compare suture-button versus syndesmotic screw in the treatment of distal tibiofibular syndesmotic injury.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suture button fixation | Experimental | Patients undergoing suture button fixation of syndesmosis injury |
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| Syndesmotic screw fixation | Experimental | Patients undergoing syndesmotic screw fixation of syndesmosis injury |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture button fixation | Procedure | Patients undergoing suture button fixation of syndesmosis injury. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months postoperatively |
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Inclusion Criteria:
- Unstable unilateral syndesmotic injuries that was considered by the attending staff surgeon to require surgical fixation, including:
Exclusion Criteria:
- Exclusion criteria include patient and injury specific factors.
Patient-related exclusion factors included:
Injury-related exclusion factors included:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| El-Sayed S El-Gamasy, MBBCh | Contact | 002 01206220396 | elsayed.sherif@med.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| Syndesmotic screw fixation | Procedure | Patients undergoing syndesmotic screw fixation of syndesmosis injury. |
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| 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 |
| 12 months Postoperatively |