Internal Plate Fixation vs. Plaster in Complete Articular Distal Radial Fractures

NCT02651779 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-03-08

No results posted yet for this study

Summary

There is no consensus about the best treatment for patients with displaced complete articular distal radius fractures (AO type C fractures). Despite this lack of consensus and the lack of available literature on comparative data to guide treatment for this patient population, operative treatment with plate fixation has gained popularity. The aim of this study is to compare the functional outcome of open reduction and plate fixation with closed reduction and plaster immobilisation in adult patients (18-75 years) with displaced complete articular distal radius fractures.

Conditions

  • Displaced Complete Articular Distal Radius Fractures

Interventions

PROCEDURE

Open reduction and internal plate fixation

OTHER

Closed reduction and plasterimmobilisation

Sponsors & Collaborators

  • Dijklander Ziekenhuis

    collaborator OTHER
  • Maasstad Hospital

    collaborator OTHER
  • Maxima Medical Center

    collaborator OTHER
  • Catharina Ziekenhuis Eindhoven

    collaborator OTHER
  • Rijnland Hospital

    collaborator OTHER
  • Diakonessenhuis, Utrecht

    collaborator OTHER
  • BovenIJ Hospital

    collaborator OTHER
  • Onze Lieve Vrouwe Gasthuis

    collaborator OTHER
  • Groene Hart Ziekenhuis

    collaborator OTHER
  • Reinier de Graaf Groep

    collaborator OTHER
  • Flevoziekenhuis

    collaborator OTHER
  • Ziekenhuis Rivierenland

    collaborator OTHER
  • Radboud University Medical Center

    collaborator OTHER
  • Ziekenhuis Amstelland

    collaborator OTHER
  • Medical Center Alkmaar

    collaborator OTHER
  • Red Cross Hospital Beverwijk

    collaborator OTHER
  • Zaans Medical Center

    collaborator OTHER
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • J. Carel Goslings, MD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • Niels W.L. Schep, MD, PhD, MSc · Maasstad Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-19
Primary Completion
2019-02-14
Completion
2019-02-14

Countries

  • Netherlands

Study Locations

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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 NCT02651779 on ClinicalTrials.gov