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Search / Trial NCT05413707

Weber B Ankle Fractures With Associated Posterior Malleolus Fracture

Launched by HAUKELAND UNIVERSITY HOSPITAL · Jun 7, 2022

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Posterior Malleolus Fractures Ankle Factures Weber B Fractures Syndesmotic Injuries Fixation Randomized Controlled Trial

ClinConnect Summary

This clinical trial is looking at the best way to treat specific types of ankle fractures, particularly those that include a small piece of bone at the back of the ankle called a posterior malleolus fracture. Researchers want to find out if fixing this bone fragment during surgery leads to better recovery and outcomes for patients compared to not fixing it. Ankle fractures are quite common, and there's still a lot of debate among doctors about the best treatment approach, especially since many practices are based on tradition rather than solid evidence.

To participate in this study, patients should be between 18 and 65 years old and have a specific type of ankle fracture known as Mason and Molly type 2A or 2B, along with a Weber B fracture. They must also have a noticeable displacement of the posterior malleolus. Eligible participants will be randomly assigned to either have the bone fragment fixed during surgery or not. The study is taking place at several hospitals in Norway, and by gathering more information, it aims to help establish clearer guidelines for treating these types of fractures in the future. If you choose to participate, you can expect to receive careful monitoring and support throughout the process.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Posterior malleolar (PM) fracture, of Mason \& Molly type 2A/2B, associated with Weber B lateral malleolar fracture, with or without medial malleolar fracture
  • Posterior malleoli \>=2 mm displaced (on CT in axial, sagital or coronal plane)
  • Patients informed, written consent
  • Age 18-65 years
  • For inclusion axial CT images are examined
  • Measurements are performed 5 millimeters (mm) cranial to the tibia plafond
  • Posterior malleolus fractures involving less than 40% of the fibular notch are included.
  • Exclusion Criteria:
  • Non-compliant patient, i.e.: dementia, alcohol- or substance abuse
  • ASA-4 patients
  • Known congenital bone decease
  • Pathological fractures
  • Immunocompromised patients
  • Tourists or patients on a short-term work/study permit
  • Previous injury or condition of the ipsilateral ankle or ipsilateral lower extremity with a resulting dysfunction
  • Poor controlled diabetes
  • Patients with known arterial insufficiency
  • Open fractures
  • Severely traumatized patients (ISS\>16)
  • Patient declines to participate in study

About Haukeland University Hospital

Haukeland University Hospital, located in Bergen, Norway, is a leading academic medical center renowned for its commitment to innovative research and high-quality patient care. As a prominent clinical trial sponsor, the hospital leverages its extensive expertise in various medical fields to facilitate cutting-edge clinical studies that aim to advance healthcare outcomes. With a multidisciplinary team of healthcare professionals and researchers, Haukeland University Hospital fosters collaboration and knowledge exchange, ensuring that trials are conducted with the highest standards of ethics, safety, and scientific rigor. Its strategic focus on translational research enhances the bridge between laboratory discoveries and real-world applications, contributing to the global body of medical knowledge.

Locations

Bergen, Vestland, Norway

Patients applied

0 patients applied

Trial Officials

Jonas M Fevang, PhD

Study Director

Helse Bergen, Haukeland University Hospital

Jostein S Nilsen, MD

Principal Investigator

Helse Bergen, Haukeland University Hospital

Kristian Pilskog, MD

Principal Investigator

Helse Bergen, Haukeland University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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