Weber B Ankle FracturesNCT05793606
The Effect of Deltoid Ligament Repair in Patients With Weber B Ankle Fracture; Randomized Controlled Trial.
A study testing Deltoid ligament repair in people with Weber B Ankle Fractures, run by Ministry of Health, Kuwait.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Weber B Ankle Fractures
- What is being tested?
- Deltoid ligament repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Deltoid ligament repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deltoid ligament repairProcedure or surgery
Surgical repair for the deltoid ligament
| Study group | Role | What they receive |
|---|---|---|
| Deltoid repaired | Active comparator | Not described Receives: Procedure: Deltoid ligament repair |
| non-deltoid repaired | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle instability measured with the Cumberland Ankle Instability Tool (CAIT)
Measured: two years
Secondary outcomes (6)
• Foot and Ankle Ability Measure
Measured: two years
• Global Rating of Function
Measured: two years
• AOFAS
Measured: two years
SF-12
Measured: two years
VAS
Measured: two years
• EQE5
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weber B Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Kuwait
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Meshal Alhadhoud, Ministry of Health, Kuwait
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793606
- Sponsor's protocol ID
- 2156/2022
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deltoid Ligament Repair in Patients With Weber B Ankle Fracture; Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05793606
- Acronym / sponsor ID
- 2156/2022
- Conditions
- Weber B Ankle Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ministry of Health, KuwaitOther government
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deltoid repaired | Active comparator | Procedure: Deltoid ligament repair |
| non-deltoid repaired | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deltoid ligament repairSurgical repair for the deltoid ligament | Procedure or surgery | Deltoid repaired |
Primary outcome
Ankle instability measured with the Cumberland Ankle Instability Tool (CAIT)
Time frame: two years
6 secondary outcomes
• Foot and Ankle Ability Measure
Time frame: two years
• Global Rating of Function
Time frame: two years
• AOFAS
Time frame: two years
SF-12
Time frame: two years
VAS
Time frame: two years
• EQE5
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Deltoid ligament repair in people with Weber B Ankle Fractures, run by Ministry of Health, Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Najla Alsiri, PhD (00965-66820032, dr.alsiri@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle instability measured with the Cumberland Ankle Instability Tool (CAIT) (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.