Fixation methods for ankle fractures with posterior malleolus involvement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of a novel posterior approach for the fixation of posterior malleolus fractures associated with Weber B ankle fractures. It aims to determine the best intervention method by comparing traditional fixation techniques with this new approach, focusing on patient-reported outcomes and clinical results. Eligible participants will undergo detailed imaging to assess fracture displacement and will be treated based on specific inclusion criteria. The study seeks to address the ongoing debate regarding optimal treatment strategies for these complex fractures.

Why it matters

Who can join: the full rules

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

Where it's running

• Haukeland University Hospital, Orthopedic department
  Bergen, Vestland, Norway Recruiting

Study contacts

• Principal investigator: Jostein S Nilsen, MD — Helse Bergen, Haukeland University Hospital
• Study coordinator: Jostein S Nilsen, MD
• Email: jostein.skorpa.nilsen@helse-bergen.no
• Phone: 004792226426

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.