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

NCT ID: NCT06313177

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-10
• Study Completion Date: 2025-03-10

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

Conditions

Syndesmotic Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group A

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

Group Type: ACTIVE_COMPARATOR

syndesmosis fixation with screws

Intervention Type: PROCEDURE

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

group B

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

Group Type: ACTIVE_COMPARATOR

syndesmosis fixation with screws

Intervention Type: PROCEDURE

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

Interventions

syndesmosis fixation with screws

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Asaad Mahmoud

Resident-orthopedic department-sohag hospital university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag university Hospital

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

mahmoud asaad, resident

Role: CONTACT

mahmoudasaad339@gmail.com

01114377005

Elshazly s Mosa, professor

Role: CONTACT

References

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.

Reference Type: BACKGROUND

PMID: 28865579 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33333279 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34267932 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7951968 (View on PubMed)

Other Identifiers

Soh-Med-24-03-03MS

Identifier Type: -

Identifier Source: org_study_id