Clinical trial NCT05793606: The Effect of Deltoid Ligament Repair in Patients With Weber B Ankle Fracture; Randomized Controlled Trial.
Official title: The Effect of Deltoid Ligament Repair in Patients With Weber B Ankle Fracture; Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Weber B Ankle Fractures
Lead sponsor: Ministry of Health, Kuwait
Sponsor class: OTHER_GOV
First posted: 2023-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Ankle instability measured with the Cumberland Ankle Instability Tool (CAIT)
timeFrame: two years
Secondary outcomes:
measure: • Foot and Ankle Ability Measure
timeFrame: two years
measure: • Global Rating of Function
timeFrame: two years
measure: • AOFAS
timeFrame: two years
measure: SF-12
timeFrame: two years
measure: VAS
timeFrame: two years
measure: • EQE5
timeFrame: two years
Other outcomes:
Locations:
Study officials:
References: