Extraarticular Distal Radius Fractures, X-fix or Volar Fixation

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Karolinska Institute

Status

Completed

Conditions

Dorsally Displaced Intraarticular Distal Radius Fractures
Age 50 - 74 for Females or 60-74 for Males
Low Energy Trauma

Treatments

Procedure: Volar plate
Procedure: External fixation

Study type

Interventional

Funder types

Other

Identifiers

NCT01034943
DRF Extra

Details and patient eligibility

About

Distal radius fractures are treated surgically if severely displaced. This study aims to investigate the outcome after surgery. The investigators will randomize patients to either external fixation with optional addition of k-wires or open reduction and fixation with a volar plate.

Full description

This study has been merged with study NCT01035359 and a new ethical permission has been granted by the Swedish National Ethic board

Enrollment

70 patients

Sex

All

Ages

50 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female 50-74 years or male 60-74 years
  • Dorsally displaced extraarticular distal radius fracture
  • Dorsal angulation >20 degrees measured from the plane perpendicular to the radius axis
  • Low energy trauma
  • Injury <72 hours when diagnosed
  • Patient independent of help for ADL

Exclusion criteria

  • Earlier dysfunction in any wrist
  • Other major injuries
  • Rheumatoid arthritis or other systemic joint disease
  • Dementia or severe psychiatric disease
  • Severe medical condition making general anesthesia a considerable risk

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

External fixation
Active Comparator group
Description:
Operation with external fixation and optional addition of k-wire
Treatment:
Procedure: External fixation
Volar plate
Active Comparator group
Description:
Operation with Synthes volar two column plate (TCP)
Treatment:
Procedure: Volar plate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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