Fixation methods for ankle fractures with posterior malleolus involvement
Posterior Malleolus Fractures (PMF) in Weber B Ankle Fractures - Fixation Versus no Fixation - a Randomized Controlled Trial
This study is testing a new way to fix certain ankle fractures to see if it works better than the usual methods for people with these types of injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 198 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Locations | 1 site (Bergen, Vestland) |
| Trial ID | NCT05413707 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with specific types of posterior malleolus fractures associated with Weber B fractures.
Not a fit: Patients with non-compliance issues, severe comorbidities, or previous ankle injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients with complex ankle fractures.
How similar studies have performed: Previous studies have shown varying success with different fixation techniques, but this specific posterior approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bergen, Vestland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.