Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05413707

Weber B Ankle Fractures With Associated Posterior Malleolus Fracture

Led by Haukeland University Hospital · Updated on 2024-02-29

198

Participants Needed

1

Research Sites

407 weeks

Total Duration

On this page

Sponsors

H

Haukeland University Hospital

Lead Sponsor

U

University Hospital, Akershus

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Weber B Ankle Fractures With Associated Posterior Malleolus Fracture

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Posterior malleolar (PM) fracture, Mason & Molly type 2A or 2B, with Weber B lateral malleolar fracture, with or without medial malleolar fracture
  • Posterior malleoli displaced 2 mm or more on CT scan
  • Posterior malleolus fractures involve less than 40% of the fibular notch
  • Age between 18 and 65 years
  • Patients able to give informed, written consent
  • Axial CT images examined with measurements 5 mm above the tibia plafond
Not Eligible

You will not qualify if you...

  • Non-compliant patients such as those with dementia or alcohol/substance abuse
  • Patients classified as ASA-4
  • Known congenital bone diseases
  • Pathological fractures
  • Immunocompromised patients
  • Tourists or short-term workers/students
  • Previous injury or dysfunction in the same ankle or lower leg
  • Poorly controlled diabetes
  • Known arterial insufficiency
  • Open fractures
  • Severely traumatized patients with Injury Severity Score greater than 16
  • Patients who decline to participate

AI-Screening

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Trial Site Locations

Total: 1 location

1

Haukeland University Hospital, Orthopedic department

Bergen, Vestland, Norway, 5021

Actively Recruiting

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Research Team

J

Jostein S Nilsen, MD

CONTACT

K

Kristian Pilskog, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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