Radiological Criteria for Instability in Distal Radius Fractures

NCT06617780 | Recruiting

• 1 other identifier: 670548
• Study Type: observational
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Distal Radius Fractures

Keywords

Wrist Fractures; Distal Forearm Fractures

Outcome Measures

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

  3 months

Secondary Outcomes (2)

• CT criterias

  1 day after the fracture is reduced

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

  1 year

Study Arms (1)

Patients with a distal radius fracture

Dorsally displaced distal radius fractures reduced to an acceptable position in patients aged 18-65 years.

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

Interventions

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

Patients with a distal radius fracture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Bergesenstiftelsen: collaborator

Study Sites (1)

Oslo University Hospital, Aker, Oslo Skadelegevakt

Oslo, Oslo County, 0587, Norway

RECRUITING

Related Publications (25)

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Related Links

• Norwegian Guidelines for Distal Radius Fractures
• British Guidelines for Distal Radius Fractures
• Danish Guidelines for Distal Radius Fractures
• Swedish Guidelines for Distal Radius Fractures

MeSH Terms

Conditions

Wrist Fractures

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Lene B. Solberg, PhD MD

  Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lene B. Solberg, PhD MD

CONTACT

+47 97669950; l.b.solberg@gmail.com

Ingrid Oftebro, MD

CONTACT

+47 98492344; ingoft@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician and postdoctoral fellow, Orthopedic Department, Oslo University Hospital

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: September 27, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): October 7, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 20, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)