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Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly

This study is currently recruiting participants.
Verified March 2016 by Kristin Olsson, Danderyd Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01268397
First Posted: December 30, 2010
Last Update Posted: March 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kristin Olsson, Danderyd Hospital
  Purpose
The purpose of this study is to examine whether operation and fixation with a metal plate gives better result from the patient's perspective than plaster treatment in elderly patients with a displaced wrist fracture.

Condition Intervention
Fracture of the Distal Radius Wrist Fracture Procedure: open reduction and internal fixation with a volar plate Procedure: closed reduction and plaster treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly. A Randomized Comparison Between Operative Fixation and Plaster Cast Treatment.

Resource links provided by NLM:


Further study details as provided by Kristin Olsson, Danderyd Hospital:

Primary Outcome Measures:
  • patient-perceived disability measured by the PRWE and DASH questionnaires [ Time Frame: one year after wrist fracture ]

Secondary Outcome Measures:
  • impairments (grip strength and range of motion compared with the uninjured wrist) [ Time Frame: one year after wrist fracture ]

Estimated Enrollment: 80
Study Start Date: December 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: open reduction and internal fixation with a volar plate Procedure: open reduction and internal fixation with a volar plate
flexor carpi radialis approach, open reduction, fixed-angle volar plate, plaster cast 2 weeks at the surgeon's discretion
Other Name: plate: Königsee or Aculoc from Swmac, Sweden
Active Comparator: closed reduction and plaster treatment Procedure: closed reduction and plaster treatment
closed reduction, below elbow plaster cast for 5 week

Detailed Description:
We will perform a prospective randomized clinical trial comparing open reduction and internal fixation with a volar plate with closed reduction and plaster treatment in elderly patients with a displaced Colles' fracture in order to test the null hypothesis that the patient-perceived result is equal after conservative or operative treatment. Secondary outcomes are objective physical measurements.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral unstable dislocated dorsally angulated fracture of the distal radius (radial shortening ≥4 mm and/or dorsal angulation ≥20°).

Exclusion Criteria:

  • Previous displaced fracture of the distal radius.
  • Additional fractures of the upper extremities, an open fracture, terminal disease, patient not fit for surgery, unwilling or unable to co-operate with follow-up (advanced dementia (SPMSQ<5), psychiatric illness, alcohol abuse).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268397


Contacts
Contact: Maria Wilcke, MD +46708294613 maria.wilcke@ds.se
Contact: Kristin Olsson, MD +4686555000 kristin.olsson@ds.se

Locations
Sweden
Division of Orthopaedics Danderyd Hospital Recruiting
Stockholm, Sweden, S-18288
Contact: Maria Wilcke, ND    +46708294613    maria.wilcke@ds.se   
Contact: Kristin Olsson, MD    +4686555000    kristin.olsson@ds.se   
Principal Investigator: Per Adolpson, MD, PhD         
Sponsors and Collaborators
Danderyd Hospital
Investigators
Study Director: Per Y Adolphson, MD, PhD Karolinska Institute at Danderyd Hospital
  More Information

Responsible Party: Kristin Olsson, MD, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT01268397     History of Changes
Other Study ID Numbers: Wilcke-02
First Submitted: December 29, 2010
First Posted: December 30, 2010
Last Update Posted: March 9, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Kristin Olsson, Danderyd Hospital:
elderly
wrist fracture
fracture of the distal radius
volar plate
plaster cast

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries