Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster (70)

March 11, 2021 updated by: Sari Ponzer, Karolinska Institutet

Dorsally Displaced Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster - A Prospective Randomized Trial

Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination.

An additional follow up at three years with X-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study.

A health economy analysis will be preformed at 1, and 3 years for the participants with complete EQ5D.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

130

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

      • Stockholm, Sweden, 11883
        • Department of Orthopaedics, Stockholm South 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

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture.
  • Low energy injury
  • Patient 70 years old or older
  • 72 hours or less since injury at time of diagnosis
  • Patient registered in the Stockholm region
  • Patient understands spoken and written swedish

Exclusion Criteria:

  • Intraarticular displacement in radiocarpal joint of more than 1 mm
  • Ulna fractured proximal to the base of the styloid process of ulna
  • Earlier unilateral functional impairment of hand/wrist
  • Injury to tendon, nerve or skin besides the fracture
  • Rheumatoid arthritis or other severe systemic joint disease
  • Severe psychiatric disorder, ongoing drug abuse or dementia (Pfeiffer score 5 points or less)
  • Besides the wrist fracture also other big injuries, for example fracture of hip, shoulder or ankle
  • Medical illness that makes general anesthesia impossible

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
No Intervention: Plaster cast
The patient will be treated in a dorsal plaster cast for 4 weeks following the injury to the wrist
Experimental: Volar plate
The patient will undergo surgery to the injured wrist with a Synthes Two-column plate (TCP) with a volar approach. Cast will be worn 2 weeks after surgery.
An anatomically countoured volar plate is implanted through a Henry's incision.
Other Names:
  • Synthes TCP volar plate for distal radius

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient related wrist evaluation (PRWE)
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient related wrist evaluation (PRWE)
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Anders Enocson, M.D, PhD, Karolinska Institutet

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.

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

April 1, 2013

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

May 2, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

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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