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Search / Trial NCT05793606

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

Launched by MINISTRY OF HEALTH, KUWAIT · Mar 20, 2023

Trial Information

Current as of November 05, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how repairing the deltoid ligament affects people with a specific type of ankle fracture known as a Weber B fibula fracture. The deltoid ligament is important for keeping the ankle stable and preventing pain or long-term issues like arthritis. Researchers want to find out if repairing this ligament during surgery can help reduce problems like ankle instability and arthritis after the injury.

To be eligible for this trial, participants must be between 18 and 55 years old and have an isolated Weber B fibula fracture with a confirmed injury to the deltoid ligament, as shown by imaging tests like X-rays, MRI, and CT scans. They should also be scheduled for surgery to repair their fibula. The trial will involve a single surgeon performing the repairs, and participants will be monitored for two years after the surgery to see how well they recover. This study is important because it aims to provide better information about the long-term benefits of deltoid ligament repair in ankle injuries.

Gender

ALL

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

About Ministry Of Health, Kuwait

The Ministry of Health in Kuwait serves as a pivotal clinical trial sponsor dedicated to advancing healthcare through rigorous research and innovation. Committed to enhancing public health outcomes, the Ministry oversees a range of clinical studies aimed at evaluating new treatments, medical devices, and healthcare strategies. By fostering collaboration among healthcare professionals, researchers, and regulatory bodies, the Ministry ensures adherence to ethical standards and regulatory compliance while promoting evidence-based practices. Its initiatives reflect a strategic focus on improving patient care and addressing the evolving health needs of the Kuwaiti population.

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Timeline

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Trial launched

Trial updated

Estimated completion

Not reported

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