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

NCT02154620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-03-15

No results posted yet for this study

Summary

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.

Conditions

  • Distal Radius Fracture

Interventions

PROCEDURE

Volar plate

An anatomically countoured volar plate is implanted through a Henry's incision.

DEVICE

Synthes TCP volar plate

Sponsors & Collaborators

Principal Investigators

  • Anders Enocson, M.D, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02154620 on ClinicalTrials.gov