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.
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
Non-compliant patient, i.e.: dementia, alcohol- or substance abuse
ASA-4 patients
Known congenital bone decease
Pathological fractures
Parallel
Fixation of the posterior malleolus fractures
Procedure/SurgeryFixation of the posterior malleolus fracture with screws and or plating.
Fixation of lateral and/or medial malleolus fractures
Procedure/SurgeryFixation with screws and/or plating
Syndesmotic fixation
Procedure/SurgeryFixation of unstable syndesmosis with one or two 3.5 mm tricortical screws, or with a suture button.
Self-Reported Foot and Ankle Score
Foot and ankle specific questionnaire with 12 questions with 5 levels. Total score from 0 (worst) to 48 (best).
EQ-5D 5L
Generic patient reported outcome questionnaire, Presentation of both change from baseline to 12 weeks, 1 year, 2, years and 5 years postoperatively. Presentation of both EQ-5D-5L frequencies and proportions reported by dimension and level, EQ-5D VAS, and EQ-5D index score.
VAS of stiffness (0-100)
Level of stiffness in the treated ankle from 0 (No stiffness) to 100 (No movement due to stiffness)
Osteoarthritis
Osteoarthritis on plain radiographs at 2- and 5-years postoperative graded by the Kellgren Lawrence classification
Dorsiflexion
\- Dorsiflexion measured by goniometer o With knee in flexion and the foot on the floor. The patient leans forward as far as possible without the heel lifting. The angle between the floor and the anterior boarder of the tibia is measured with a digital goniometer.
Anchor questions for evaluation of prom
Generic and organ specific anchor questions for evaluation of SEFAS results and for patients satisfaction evaluation.
Click on the lead sponsor to view all of their trials.
Haukeland University Hospital
Lead sponsor
University Hospital, Akershus
Collaborator
Ullevaal University Hospital
Collaborator
Helse Stavanger HF
Collaborator
Alesund Hospital
Collaborator
Ostfold Hospital Trust
Collaborator
St. Olavs Hospital
Collaborator
Helgeland Hospital Trust
Collaborator
