This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Intraarticular Distal Radius Fractures, X-fix or Volar Fixation

This study has been completed.
Information provided by (Responsible Party):
Sari Ponzer, Karolinska Institutet Identifier:
First received: December 16, 2009
Last updated: March 12, 2014
Last verified: March 2014
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dorsally Displaced Intraarticular Distal Radius Fractures - Volar Plate or External Fixation. A Prospective Randomized Trial.

Resource links provided by NLM:

Further study details as provided by Sari Ponzer, 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 ]

Secondary Outcome Measures:
  • A secondary outcome is the degree of malalignment on the x-ray of the injured wrist. [ Time Frame: 12 months ]
  • A secondary outcome of this study is the EQ5D, which is a validated quality-of-life instrument. [ Time Frame: 12 months ]

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
Bridging external fixation of a distal radius fracture with an optional addition of k-wire(s)
Other Name: Stryker's Hoffman external fixation
Experimental: Volar plate
Operation with a Synthes volar two column plate (TCP)
Procedure: Volar plate
Operation of distal radius fracture with open reduction and fixation with a plate from the volar side of the wrist.
Other Name: Synthes Two Column Plate (TCP)

Detailed Description:
This study has been merged with NCT 01034943 and a new permit has been issued by the Swedish National board on Ethical Permits

Ages Eligible for Study:   50 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female 50-74 years or male 60-74 years
  • Dorsally displaced intraarticular 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 major 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 identifier: NCT01035359

Stockholm South Hospital Department of Orthopeadic Surgery
Stockholm, Sweden, 11883
Sponsors and Collaborators
Karolinska Institutet
  More Information

Responsible Party: Sari Ponzer, Professor, MD, Senior consultant orthopaedic surgeon, Karolinska Institutet Identifier: NCT01035359     History of Changes
Other Study ID Numbers: DRF intra
Study First Received: December 16, 2009
Last Updated: March 12, 2014

Keywords provided by Sari Ponzer, Karolinska Institutet:

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries processed this record on September 21, 2017