Extraarticular Distal Radius Fractures, X-fix or Volar Fixation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sari Ponzer, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01034943
First received: December 16, 2009
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Dorsally Displaced Intraarticular Distal Radius Fractures
Age 50 - 74 for Females or 60-74 for Males
Low Energy Trauma
Procedure: External fixation
Procedure: Volar plate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dorsally Displaced Extraarticular Distal Radius Fractures - Volar Plate or External Fixation. A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • The primary outcome is measured by DASH (Disability of the Arm, Shoulder and Hand), which is a self administered questionnaire validated for disease and dysfunction of the upper limb. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A secondary outcome measure is the degree of malalignment on the x-ray of the injured wrist. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • A secondary outcome measure for this study is the EQ5D, a validated quality-of-life instrument. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: August 2009
Study Completion Date: February 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: External fixation
Operation with external fixation and optional addition of k-wire
Procedure: External fixation
Operation with external fixation and optional addition of k-wire
Other Name: External Fixation with Hoffman external fixator (Stryker)
Active Comparator: Volar plate
Operation with Synthes volar two column plate (TCP)
Procedure: Volar plate
Operation with a Synthes volar two column plate (TCP)
Other Name: Synthes volar two column plate (TCP)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034943

Locations
Sweden
Stockholm South Hospital Department of Orthopeadic Surgery
Stockholm, Sweden, 118 83
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Sari Ponzer, Professor Karolinska Institutet
  More Information

No publications provided

Responsible Party: Sari Ponzer, Professor, MD, Consultant orthopeadic surgeon, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01034943     History of Changes
Other Study ID Numbers: DRF Extra
Study First Received: December 16, 2009
Last Updated: March 12, 2014
Health Authority: Swedish National Council on Medical Ethics, Sweden:

Keywords provided by Karolinska Institutet:
radius
fracture
wrist
external
fixation
volar
plate
DASH
PRWE

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on July 23, 2014