Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 August 28, 2014