NCT05413707 Weber B Ankle Fractures With Associated Posterior Malleolus Fracture
| NCT ID | NCT05413707 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Haukeland University Hospital |
| Condition | Posterior Malleolus Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 198 participants |
| Start Date | 2023-03-13 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 198 participants in total. It began in 2023-03-13 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Ankle fractures constitute 9% of all fractures and have an incidence of approximately 187 per 100,000 persons per year in Norway. A posterior malleolar fragment (PMF), located on the lower backside of the tibia, is present in up to 46% of Weber B. Weber B fractures are the most common type of fractures of the fibula, located at the height of the syndesmosis. Patients with a PMF were recently shown to have significantly lower patient-reported outcome measures (PROM) than the general population. For this reason, the indication and choice of intervention for these fractures have been the object of increased interest over the recent years. It is one of the most debated areas within ankle fracture surgery. Traditionally, these PMFs have been treated with closed reduction, without direct manipulation of the PMF, anteroposterior screw fixation, or even no-fixation of the smaller fragments. A more novel posterior approach to the ankle for open reduction and internal fixation is increasingly popular and has led to fixation of smaller and medium-sized PMFs. Studies suggest fracture reduction is better with a posterior approach. However, there is no consensus as to what the best treatment is. There are no available randomized controlled studies examining PROM in patients after surgery with fixation versus no fixation for the PMF. Through a multicenter prospective randomized controlled trial initiated from Haukeland University Hospital, patients will be recruited and randomized to receive treatment with or without fixation of the PMF. Patients will be recruited at six study hospitals from all Regional Health Trusts in Norway. Treatment today is often based on local tradition and retrospective, ambiguous literature. As there is no clear evidence supporting the choice to fixate, or not fixate, the posterior malleolus fracture. The current study can contribute new knowledge and thereby contribute to an evidence-based approach to treating these patients. Mason and Molly type 2A and 2B fractures will be included in the study.
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
Contact & Investigator
Jonas M Fevang, PhD
STUDY DIRECTOR
Helse Bergen, Haukeland University Hospital
Frequently Asked Questions
Who can join the NCT05413707 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Posterior Malleolus Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05413707 currently recruiting?
Yes, NCT05413707 is actively recruiting participants. Contact the research team at jostein.skorpa.nilsen@helse-bergen.no for enrollment information.
Where is the NCT05413707 trial being conducted?
This trial is being conducted at Bergen, Norway.
Who is sponsoring the NCT05413707 clinical trial?
NCT05413707 is sponsored by Haukeland University Hospital. The principal investigator is Jonas M Fevang, PhD at Helse Bergen, Haukeland University Hospital. The trial plans to enroll 198 participants.