Evaluating radiological criteria for stability in wrist fractures
Radiological Criteria for Instability in Distal Radius Fractures
Oslo University Hospital · NCT06617780
This study tests if certain X-ray and CT scan results can help doctors decide if adults with wrist fractures need surgery after a closed reduction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 212 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Oslo University Hospital (other) |
| Locations | 1 site (Oslo, Oslo) |
| Trial ID | NCT06617780 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the radiological criteria that can indicate whether a dorsally displaced distal radius fracture remains stable after closed reduction. It focuses on patients aged 18 to 65 years and aims to establish criteria that could help determine if surgical intervention is necessary. The study involves X-ray imaging after three months and CT scans the day after the closed reduction procedure to assess fracture stability. The goal is to improve treatment decisions and outcomes for patients with wrist fractures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with specific types of dorsally displaced distal radius fractures.
Not a fit: Patients with volar comminution, open fractures, or significant prior wrist injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of fracture stability, potentially reducing unnecessary surgeries and improving patient outcomes.
How similar studies have performed: While there have been attempts to establish criteria for fracture stability, this study addresses a gap in standardization and could provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criterias: * 18-65 years old, living in Oslo/surroundings (available for follow-up) * AO class A2/3 or C1/C2 fractures * Dorsally displaced fracture of the distal radius (minimum VLDV more than100 or ulnar variance more than 2 mm compared to healthy side before reduction) with or without PSU fracture * Reduced to an acceptable position (VLDV 75-95 degrees, RIV more than 15 degrees, ulnar variance more than 2 mm, step/diastasis in the joint surface less than 2 mm) Exclution criterias: * Volar comminution (AO A3.3), step/diastasis more than 2 mm before reduction * Ad latus more than 2 cortex widths after reduction * Bilateral fractures * Open fractures * Previous wrist fracture in adulthood * Still open growth disc on X-ray * Antebrachium or carpal fracture * Ligament damage in the root of the hand or DRUJ * Lack of compliance (dementia, psychiatry/drug abuse, etc.) * Language problems * Rheumatoid arthritis or other systemic disease that can affect the result
Where this trial is running
Oslo, Oslo
- Oslo University Hospital, Aker, Oslo Skadelegevakt — Oslo, Oslo, Norway (RECRUITING)
Study contacts
- Principal investigator: Lene B. Solberg, PhD MD — Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway
- Study coordinator: Lene B. Solberg, PhD MD
- Email: l.b.solberg@gmail.com
- Phone: +47 97669950
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.
Conditions: Distal Radius Fractures, Wrist Fractures, Distal Forearm Fractures