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Clinical Trials/NCT01268397
NCT01268397
Unknown
Not Applicable

Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly. A Randomized Comparison Between Operative Fixation and Plaster Cast Treatment.

Danderyd Hospital1 site in 1 country80 target enrollmentDecember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fracture of the Distal Radius
Sponsor
Danderyd Hospital
Enrollment
80
Locations
1
Primary Endpoint
patient-perceived disability measured by the PRWE and DASH questionnaires
Last Updated
7 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
December 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Danderyd Hospital
Responsible Party
Principal Investigator
Principal Investigator

Sara Severin Wahlgren

MD

Danderyd Hospital

Eligibility 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).

Outcomes

Primary Outcomes

patient-perceived disability measured by the PRWE and DASH questionnaires

Time Frame: one year after wrist fracture

Secondary Outcomes

  • impairments (grip strength and range of motion compared with the uninjured wrist)(one year after wrist fracture)

Study Sites (1)

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