Ankle Syndesmotic Diastasis, Fixation, Suture Button, Syndesmotic Screw
Conditions
Brief summary
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
PROCEDURESuture button fixation
Patients undergoing suture button fixation of syndesmosis injury.
PROCEDURESyndesmotic screw fixation
Patients undergoing syndesmotic screw fixation of syndesmosis injury.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The American Orthopaedic Foot and Ankle Society (AOFAS) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain | 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. |
| Ankle Range of motion (ROM) | 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 |
Countries
Egypt
Contacts
Primary ContactEl-Sayed S El-Gamasy, MBBCh
Outcome results
None listed