Weber B Ankle Fractures With Associated Posterior Malleolus Fracture

NCT05413707 · tracked via the Priya Life Science Norway tracker

Sponsor

Haukeland University Hospital

Phase

Not applicable

Started

2023-03-13

Last updated

2024-02-29

Condition(s) studied

Posterior Malleolus FracturesAnkle FracturesSyndesmotic InjuriesPatient Reported Outcome MeasureTreatment Outcome

Investigational drug(s) / intervention(s)

Fixation of the posterior malleolus fracturesFixation of lateral and/or medial malleolus fracturesSyndesmotic fixation

Fixation of the posterior malleolus fractures: Fixation of the posterior malleolus fracture with screws and or plating.

Fixation of lateral and/or medial malleolus fractures: Fixation with screws and/or plating

Syndesmotic fixation: Fixation of unstable syndesmosis with one or two 3.5 mm tricortical screws, or with a suture button.

Study 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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

Self-Reported Foot and Ankle Score — 2 years postoperatively
Foot and ankle specific questionnaire with 12 questions with 5 levels. Total score from 0 (worst) to 48 (best).

Trial sites (1)

Facility	City	Region	Status
Haukeland University Hospital, Orthopedic department	Bergen	Vestland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05413707 on ClinicalTrials.gov ↗ ← All trials in Norway