Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly

This study is currently recruiting participants.
Verified December 2011 by Danderyd Hospital
Sponsor:
Information provided by (Responsible Party):
Maria Wilcke, Danderyd Hospital
ClinicalTrials.gov Identifier:
NCT01268397
First received: December 29, 2010
Last updated: December 9, 2011
Last verified: December 2011
  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: 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 Danderyd Hospital:

Primary Outcome Measures:
  • patient-perceived disability measured by the PRWE and DASH questionnaires [ Time Frame: one year after wrist fracture ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • impairments (grip strength and range of motion compared with the uninjured wrist) [ Time Frame: one year after wrist fracture ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Maria Wilcke, MD, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT01268397     History of Changes
Other Study ID Numbers: Wilcke-02
Study First Received: December 29, 2010
Last Updated: December 9, 2011
Health Authority: Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 15, 2014