Actively Recruiting

Age: 18Years - 65Years
All Genders
ID06617780

Radiological Criteria for Instability in Distal Radius Fractures

Led by Oslo University Hospital · Updated on 2025-03-20

212

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

Sponsors

O

Oslo University Hospital

Lead Sponsor

B

Bergesenstiftelsen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating radiological criteria to determine if dorsally displaced distal radius fractures in adults aged 18 to 65 remain stable without surgery after closed reduction. This study addresses the need to identify fractures that maintain proper positioning in a cast to avoid unnecessary operations, which can cause complications and stress. It aims to refine current guidelines by focusing on specific fracture types and characteristics, especially considering factors like volar hook and dorsal comminution. Participants with dorsally displaced distal radius fractures that are reduced to an acceptable position will undergo routine closed reduction using traction methods by experienced doctors. The study includes X-rays before and after reduction, a CT scan the day after reduction, and follow-up imaging at 6-8 days, 3 weeks, 5 weeks, and 3 months to monitor fracture stability. Patients between 50 and 65 years old will be evaluated for osteoporosis or osteopenia to assess how bone health affects fracture stability. During the study, participants will have imaging exams including X-rays and CT scans to measure fracture alignment and healing. Experienced doctors will review the images to decide if the fracture remains stable or requires surgery. Researchers will track complications such as complex regional pain syndrome and malunion. The main outcome is the radiological status of the fracture three months after injury, with additional assessments shortly after reduction and one year later for bone health effects. The study is planned to enroll about 212 patients over two years at a hospital outpatient clinic.

CONDITIONS

Brief Title

Radiological Criteria for Instability in Distal Radius Fractures

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years living in Oslo or surrounding areas and available for follow-up
  • Distal radius fractures classified as AO A2/A3 or C1/C2
  • Dorsally displaced distal radius fracture with specific displacement measurements before reduction
  • Fracture reduced to an acceptable position based on defined radiological criteria
Not Eligible

You will not qualify if you...

  • Volar comminution or joint surface step/diastasis more than 2 mm before reduction
  • Radial displacement more than two cortical widths after reduction
  • Bilateral or open fractures
  • Previous wrist fracture in adulthood
  • Open growth plate on X-ray
  • Fractures in forearm or carpal bones
  • Ligament damage in hand or distal radioulnar joint
  • Lack of compliance due to dementia, psychiatric conditions, or drug abuse
  • Language barriers
  • Rheumatoid arthritis or other systemic diseases affecting results

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 3 months

Participants with dorsally displaced distal radius fractures reduced to an acceptable position will have X-rays and CT scans taken before and after reduction to assess fracture stability.

X-ray and CT scans on the day after reduction, and follow-up X-rays approximately at 6-8 days, possibly a third follow-up within 3 weeks if needed, cast removal X-ray at 5 weeks, and final X-ray at 3 months

Trial Site Locations

Total: 1 location

1

Oslo University Hospital, Aker, Oslo Skadelegevakt

Oslo, Oslo, Norway, 0587

Actively Recruiting

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Research Team

L

Lene B. Solberg, PhD MD

I

Ingrid Oftebro, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Cast immobilization is non-inferior to volar locking plates in relation to QuickDASH after one year in patients aged 65 years and older: a randomized controlled trial of displaced distal radius fractures.

Sondre Stafsnes Hassellund, John Håkon Williksen, Marit Mjelde Laane...

https://pubmed.ncbi.nlm.nih.gov/33517725

Determining the Borderline Anatomical Parameters for Better Functional Outcome of Colles Fracture: A Prospective Study.

Tapasa Kumar Panigrahi, Satyajeet Ray, Manoranjan Mallik...

https://pubmed.ncbi.nlm.nih.gov/35966419

Closed reduction of colles fractures: comparison of manual manipulation and finger-trap traction: a prospective, randomized study.

S A Earnshaw, A Aladin, S Surendran...

https://pubmed.ncbi.nlm.nih.gov/11886903

Volar Plate Fixation Versus Cast Immobilization in Acceptably Reduced Intra-Articular Distal Radial Fractures: A Randomized Controlled Trial.

C A Selles, M A M Mulders, J Winkelhagen...

https://pubmed.ncbi.nlm.nih.gov/34314402