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Clinical Trials/NCT06313177
NCT06313177UnknownNot Applicable

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

Sohag University1 site in 1 country40 target enrollmentStarted: March 10, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
40
Locations
1
Primary Endpoint
pain with AOFAS score

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

group A

Active Comparator

group(A) cases with ankle in neutral position during syndesmosis fixation

Intervention: syndesmosis fixation with screws (Procedure)

group B

Active Comparator

group(B) cases with ankle in dorsiflexion position during syndesmosis fixation

Intervention: syndesmosis fixation with screws (Procedure)

Outcomes

Primary Outcomes

pain with AOFAS score

Time Frame: 1 year

The 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Asaad Mahmoud

Resident-orthopedic department-sohag hospital university

Sohag University

Study Sites (1)

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