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Syndesmotic Screw in Neutral Position Versus Maximum Ankle Dorsiflexion in Ankle Fractures; Comparative Study.

Syndesmotic Screw in Neutral Position Versus Maximum Ankle Dorsiflexion in Ankle Fractures; Comparative Study.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06313177
Enrollment
40
Registered
2024-03-15
Start date
2024-03-10
Completion date
2025-03-10
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syndesmotic Injuries

Brief summary

Ankle fracture is one of the most common orthopedic injuries. Approximately, 20% of surgically treated ankle fractures are associated with syndesmotic instability.According to the mechanism of the injury the syndesmotic disruption should be considered in Danis-Weber C-type fractures. However, such injuries were also frequently seen in Danis-Weber B-type fractures. Failure to detect and repair syndesmotic injuries early may result in poor clinical outcomes and complications affecting ankle function, such as long-term residual pain, post traumatic arthritis, and ankle impingement syndromes. Therefore, aggressive treatment is important when facing syndesmotic instability . The distal tibiofibular syndesmosis is important for stability of the ankle mortise and thus for weight transmission and walking. Syndesmotic injuries are most commonly associated with fibular fractures, but they can also occur in isolation or with damage to the lateral ankle ligament after traumatic supination. The need for syndesmotic fixation of the distal tibiofibular joint has been controversia. fracture does not correlate reliably with the extent of the interosseous membrane tears identified on MRI of ankle fractures, and thus estimation of the integrity of the interosseous membrane and subsequent need for trans-syndesmotic fixation cannot be based solely on the level of the fibular fracture. An intraoperative syndesmotic stress test can establish the presence or absence of syndesmotic instability, evaluating the integrity of the syndesmosis by grasping the stabilised fibula with a hook or clamp and pulling it laterally. If more than 3 or 4 mm of lateral displacement occurs, syndesmotic fixation is necessary. Most authors recommend surgical placement of a trans-fixation screw after anatomical reduction of the syndesmosis if a disruption is diagnosed to avoid complications.The main aims of treatment for dislocation of the distal tibiofibular syndesmosis are to restore the original anatomy and normal function and to recreate the stability of the ankle joint. The syndesmosis is traditionally fixed with a metallic screw, which is a method that has been used for decades and demonstrates good to excellent outcomes. Some surgeons prefer Fixation of syndesmosis with screw in maximum ankle dorsiflexion and others prefer fixation in neutral position of ankle.in this study we are going to compare between these two

Interventions

PROCEDUREsyndesmosis fixation with screws

syndesmosis fixation with Syndesmotic screw in neutral position versus maximum ankle dorsiflexion in ankle fracture

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* patients with fracture Ankle type C and type B associated with syndesmotic injury

Exclusion criteria

* pathologic fractures * Maisonneuve fractures * medical illness or mental disorders affecting the follow-up examination * loss to follow-up

Design outcomes

Primary

MeasureTime frameDescription
pain with AOFAS score1 yearThe AOFAS ankle-hindfoot score is a clinical rating system associated patients-reported outcomes with clinician-measured outcomes to make a 100-point scale that comprises nine questions in approximately three categories: pain (one question; 40 points), function (seven questions; 50 points) and alignment (one question; 10 points). Through this questionnaire, the condition of the ankle could be described in a more comprehensive and simple way

Countries

Egypt

Contacts

Backup ContactElshazly s Mosa, professor
Primary Contactmahmoud asaad, resident
mahmoudasaad339@gmail.com01114377005

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026