Weber B Ankle Fractures With Associated Posterior Malleolus Fracture

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.

Conditions

• Posterior Malleolus Fractures
• Ankle Fractures
• Syndesmotic Injuries
• Patient Reported Outcome Measure
• Treatment Outcome

Interventions

PROCEDURE

Fixation of the posterior malleolus fractures

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

PROCEDURE

Fixation of lateral and/or medial malleolus fractures

Fixation with screws and/or plating

PROCEDURE

Syndesmotic fixation

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

Sponsors & Collaborators

• University Hospital, Akershus

  collaborator OTHER

• Ullevaal University Hospital

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• Alesund Hospital

  collaborator OTHER

• Ostfold Hospital Trust

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• Helgeland Hospital Trust

  collaborator OTHER

• Haukeland University Hospital

  lead OTHER

Principal Investigators

• Jonas M Fevang, PhD · Helse Bergen, Haukeland University Hospital

• Jostein S Nilsen, MD · Helse Bergen, Haukeland University Hospital

• Kristian Pilskog, MD · Helse Bergen, Haukeland University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-13

Primary Completion

2025-12-31

Completion

2030-12-31

Countries

• Norway

Study Locations