Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly (VOCAL)

February 6, 2019 updated by: Sara Severin Wahlgren, Danderyd Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, S-18288
        • Division of Orthopaedics Danderyd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ORIF
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 Names:
  • plate: Königsee or Aculoc from Swemac, Sweden
Active Comparator: plaster treatment
Closed reduction and plaster treatment
Procedure: closed reduction and plaster treatment
closed reduction, below elbow plaster cast, semicircular for 5 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
patient-perceived disability measured by the PRWE and DASH questionnaires
Time Frame: one year after wrist fracture
one year after wrist fracture

Secondary Outcome Measures

Outcome Measure
Time Frame
impairments (grip strength and range of motion compared with the uninjured wrist)
Time Frame: one year after wrist fracture
one year after wrist fracture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danderyd Hospital

Collaborators

Stockholm South General Hospital

Investigators

  • Study Director: Per Y Adolphson, MD, PhD, Karolinska Institute at Danderyd Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 29, 2010

First Submitted That Met QC Criteria

December 29, 2010

First Posted (Estimate)

December 30, 2010

Study Record Updates

Last Update Posted (Actual)

February 8, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wilcke-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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