Health TrialsbyHealthPanel

Radiological Criteria for Instability in Distal Radius Fractures

ConditionDistal Radius Fractures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorOslo University Hospital

About this trial

The study examines whether there are radiological criteria that can give an indication if a dorsally displaced distal radius fracture remains stable without the needs for surgery after closed reduction in patients between 18 and 65 years of age.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial population

Patients at the outpatient clinic at the Ortopedic department, Oslo University Hospital, Ullevål, with a dorsally displaced distal radius fracture, aged 18-65 years, reduced to an acceptable postition, included in a 2 year period (oct 2024 - oct 2026).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • X-ray (wrist)after 3 months and CT (wrist) the day after closed reduction

    Radiation

    One addition x-ray and on addition CT scan of the wrist

Treatment groups

212 Participants
are divided into 1 treatment group
Group A: Patients with a distal radius fracture1 intervention

Trial outcomes

Primary outcomes

1

Radiological criterias 3 months after fracture

Whitch of the pre-defined radiological criterias (with a focus on dorsal comminution and volar hook) measured on x-ray before and after closed reduction can predict alignment 3 months after fracture

Time frame
3 months

Secondary outcomes

1

CT criterias

Grade different radiological criterias on CT, such as comminution and volar hook. Study intra/inter-observer reliability in these gradings.

Time frame
1 day after the fracture is reduced
2

How osteoporosis/osteopenia may affect instability in the age group 50-65

Count how many of the patients aged 50-65 that have osteoporosis/osteopenia or who are assessed with this during the course of the study. (Assessment for osteoporosis/osteopenia is part of the ordinary clinical treatment program for patients over 50 years with a distal radius fracture.) Investigate whether those with osteoporosis/osteopenia have worse alignment on X-ray after 3 months than those without osteoporosis/osteopenia and whether the fractures in this age group have a greater tendency towards instability.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oslo University Hospital

Lead sponsor

Bergesenstiftelsen

Collaborator

Source ClinicalTrials.gov
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