The Effect of Deltoid Ligament Repair in Patients With Weber B Ankle Fracture; Randomized Controlled Trial.

NCT ID: NCT05793606

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-05-01

Brief Summary

Ankle injuries are common in musculoskeletal practice with high incidence rate in physically active individuals. Ankle injuries are complex to managed and further complicated with the high recurrence rate, chronic ankle instability, and osteoarthritis (Herzog et al., 2019). The prime ankle stabilizer against valgus forces is the deltoid ligament, which is a triangle band of strong connective tissues to prevent inward ankle rotation. The deltoid ligament is vital for maintaining ankle stability against valgus forces by its deep and superficial components as it restrains eversion and external rotation of the talus on the tibia (Lee et al., 2019). The superficial components of the deltoid ligament are the tibiospring, tibionavicular, tibiocalcaneal and superficial posterior tibiotalar ligaments, while the deep components are the anterior and posterior tibiotalar ligaments. The deep components of the deltoid ligament are the main stabilizers for the ankle joint, while the superficial components have minimal stabilization role (Michelsen et al., 1996; Pankovich, 2002; Jeong et al., 2014). Retraction of the deltoid ligament could cause medial ankle instability, pain, reduce function and early osteoarthritis (Lee et al., 2019). The deltoid ligament is essential for normal functioning of the foot and ankle and to maintain the normal kinematics of the talocrural kinematics. Dodd, Halai and Buckely (2022) discussed based on Ramsey and Hamilton's (1976) and Lubbeke et al..'s (2012) studies that a one mm lateral shift of the talus reduces the contact area of the tibiotalar up to 42%, and medial-sided injuries including an injury to the deltoid ligament would lead to long-term arthritis (Ramsey and Hamilton, 1976; Lubbeke et al., 2012; Dodd, Halai amd Buckley, 2022). More importantly, the deltoid ligament frequently raptures in association with ankle fractures (Wang et al., 2020). However, a recent systematic review stated that there is no consensus regarding deltoid ligament repair and its associated effectiveness and complications (Dodd, Halai and Buckely, 2022). Moreover, no study has explored the long-term effect of deltoid ligament repair in reducing post-traumatic ankle instability and osteoarthritis in patients with weber B fibula fractures. Therefore, the aim of the study is to determine the effect of deltoid ligament repair in patient with Weber B fibular fracture using randomized controlled trial design and two years follow-up period.

Conditions

Weber B Ankle Fractures

Study Design

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

Study Groups

Deltoid repaired

Group Type: ACTIVE_COMPARATOR

Deltoid ligament repair

Intervention Type: PROCEDURE

Surgical repair for the deltoid ligament

non-deltoid repaired

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Deltoid ligament repair

Surgical repair for the deltoid ligament

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Female and male subjects.

2. Age 18-55 years.

3. Diagnosed with isolated weber B fibula facture with deltoid ligament injury confirm with radiography, MRI and CT scan. CT scan will be used to see the rotational element of the talus in the axial cuts and MRI to confirm the superficial ligament rupture.

4. Assigned for ORIF for the fibula.

5. One surgeon (MA) will perform the surgical intervention

Exclusion Criteria

1. Patient with open fractures and syndesmotic injury

2. Previous ankle injury.

3. Multiple trauma of the lower extremities.

4. Rheumatoid arthritis or other chronic inflammatory condition.

5. Previous history of ankle instability

6. Ankle osteoarthritis

7. No osteochondral lesion

8. BMI > 35

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Kuwait

OTHER_GOV

Sponsor Role: lead

Responsible Party

Meshal Alhadhoud

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Najla Alsiri, PhD

Role: CONTACT

Phone: 00965-66820032

Email: dr.alsiri@outlook.com

Other Identifiers

2156/2022

Identifier Type: -

Identifier Source: org_study_id