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

March 20, 2023 updated by: Meshal Alhadhoud, Ministry of Health, Kuwait
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Deltoid repaired
Procedure: Deltoid ligament repair
Surgical repair for the deltoid ligament
No Intervention: non-deltoid repaired

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Ankle instability measured with the Cumberland Ankle Instability Tool (CAIT)
Time Frame: two years
two years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
• Foot and Ankle Ability Measure
Time Frame: two years
two years
• Global Rating of Function
Time Frame: two years
two years
• AOFAS
Time Frame: two years
two years
SF-12
Time Frame: two years
two years
VAS
Time Frame: two years
two years
• EQE5
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ministry of Health, Kuwait

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2156/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings