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

Primary Purpose

Weber B Ankle Fractures

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deltoid ligament repair
Sponsored by
Ministry of Health, Kuwait
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weber B Ankle Fractures

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Deltoid repaired

    non-deltoid repaired

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    • Foot and Ankle Ability Measure
    • Global Rating of Function
    • AOFAS
    SF-12
    VAS
    • EQE5

    Full Information

    First Posted
    March 20, 2023
    Last Updated
    March 20, 2023
    Sponsor
    Ministry of Health, Kuwait
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05793606
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2025 (Anticipated)
    Study Completion Date
    May 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ministry of Health, Kuwait

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weber B Ankle Fractures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Deltoid repaired
    Arm Type
    Active Comparator
    Arm Title
    non-deltoid repaired
    Arm Type
    No Intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    Deltoid ligament repair
    Intervention Description
    Surgical repair for the deltoid ligament
    Primary Outcome Measure Information:
    Title
    Ankle instability measured with the Cumberland Ankle Instability Tool (CAIT)
    Time Frame
    two years
    Secondary Outcome Measure Information:
    Title
    • Foot and Ankle Ability Measure
    Time Frame
    two years
    Title
    • Global Rating of Function
    Time Frame
    two years
    Title
    • AOFAS
    Time Frame
    two years
    Title
    SF-12
    Time Frame
    two years
    Title
    VAS
    Time Frame
    two years
    Title
    • EQE5
    Time Frame
    two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Najla Alsiri, PhD
    Phone
    00965-66820032
    Email
    dr.alsiri@outlook.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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