Prospective Randomized Comparison of Conservative and Opertaive Treatment of Radius Fractures in Elderly Patients

August 19, 2022 updated by: Kepler University Hospital

Elderly Patients often suffer from radius fracture. Treatment options are conservative and operative. Aim of the stdy is to find out if there are diffrences in Patient's satisfaction depending on the different treatment.

A randomized prospective trial is palnned

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients of 70 years and more of age who suffer from C1 or C2 radius fracture are randomized treated by conservative treatment and operative treatment.

Primary aim is PRWE, secondary ROM as well as power and DASH score.

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 Contact

Study Locations

  • Austria
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Recruiting
        • Kepler University Hospital
        • Contact:
        • Principal Investigator:
          • Stefan M Froschauer, MD
        • Sub-Investigator:
          • David Haslhofer, MD

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:

  • Radius Fractures C1-C2
  • age over 70

Exclusion Criteria:

  • demetia
  • collateral damages
  • age < 70

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Operative Arm
Radius fractures C1/C2 treated by palmar plate fixation
Device: Palmar Plate Fixation
Patients are treated by surgery (palmar plate)
No Intervention: Conservative Arm
Radius Fractures C1/C2 treated by cast fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Related Wrist Evaulation
Time Frame: 12-24 months post intervention
PRWE, ROM investigation
12-24 months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ROM
Time Frame: 12-24 months post intervention
PRWE, ROM, Investigation
12-24 months post intervention

Collaborators and Investigators

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

Sponsor

Kepler University Hospital

Investigators

  • Study Director: Stefan M Froschauer, MD, Kepler University Hospital Linz

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 (Actual)

November 1, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

November 30, 2020

First Posted (Actual)

December 7, 2020

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUK-UNF-20-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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