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

Syndesmotic Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313177
• Other study ID #: Soh-Med-24-03-03MS
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2024
• Est. completion date: March 10, 2025

Study information

• Verified date: March 2024
• Source: Sohag University
• Contact: mahmoud asaad, resident
• Phone: 01114377005
• Email: mahmoudasaad339[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 10, 2025
• Est. primary completion date: March 10, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Ankle Injuries
• Syndesmotic Injuries

Intervention

Procedure:
• syndesmosis fixation with screws
syndesmosis fixation with Syndesmotic screw in neutral position versus maximum ankle dorsiflexion in ankle fracture

Locations

Country	Name	City	State
Egypt	Sohag university Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Cornu O, Manon J, Tribak K, Putineanu D. Traumatic injuries of the distal tibiofibular syndesmosis. Orthop Traumatol Surg Res. 2021 Feb;107(1S):102778. doi: 10.1016/j.otsr.2020.102778. Epub 2020 Dec 14. — View Citation

Corte-Real N, Caetano J. Ankle and syndesmosis instability: consensus and controversies. EFORT Open Rev. 2021 Jun 28;6(6):420-431. doi: 10.1302/2058-5241.6.210017. eCollection 2021 Jun. — View Citation

Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994 Jul;15(7):349-53. doi: 10.1177/107110079401500701. — View Citation

van Zuuren WJ, Schepers T, Beumer A, Sierevelt I, van Noort A, van den Bekerom MPJ. Acute syndesmotic instability in ankle fractures: A review. Foot Ankle Surg. 2017 Sep;23(3):135-141. doi: 10.1016/j.fas.2016.04.001. Epub 2016 Apr 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain with AOFAS score	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	1 year