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

NCT05793606 | Not Yet Recruiting DMC

• 1 other identifier: 2156/2022
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Ankle instability measured with the Cumberland Ankle Instability Tool (CAIT)

  two years

Secondary Outcomes (6)

• • Foot and Ankle Ability Measure

  two years

• • Global Rating of Function

  two years

• • AOFAS

  two years

• SF-12

  two years

• VAS

  two years

Study Arms (2)

Deltoid repaired

ACTIVE COMPARATOR

Procedure: Deltoid ligament repair

non-deltoid repaired

NO INTERVENTION

Interventions

Deltoid ligament repair PROCEDURE

Surgical repair for the deltoid ligament

Deltoid repaired

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female and male subjects.
• Age 18-55 years.
• 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.
• Assigned for ORIF for the fibula.
• One surgeon (MA) will perform the surgical intervention

You may not qualify if:

• Patient with open fractures and syndesmotic injury
• Previous ankle injury.
• Multiple trauma of the lower extremities.
• Rheumatoid arthritis or other chronic inflammatory condition.
• Previous history of ankle instability
• Ankle osteoarthritis
• No osteochondral lesion
• BMI \> 35

Sponsors & Collaborators

• Ministry of Health, Kuwait: lead

Central Study Contacts

Najla Alsiri, PhD

CONTACT

00965-66820032; dr.alsiri@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: March 31, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: March 31, 2023

Record last verified: 2023-03