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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04655768
Recruitment Status : Recruiting
First Posted : December 7, 2020
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
Kepler University Hospital

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment Phase
Orthopedic Disorder Device: Palmar Plate Fixation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Randomized Comparison of Conservative and Opertaive Treatment of Radius Fractures in Elderly Patients
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Patient Related Wrist Evaulation [ Time Frame: 12-24 months post intervention ]
    PRWE, ROM investigation


Secondary Outcome Measures :
  1. ROM [ Time Frame: 12-24 months post intervention ]
    PRWE, ROM, Investigation


Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Radius Fractures C1-C2
  • age over 70

Exclusion Criteria:

  • demetia
  • collateral damages
  • age < 70
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04655768


Contacts
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Contact: Stefan M Froschauer, MD +4373278061020 stefan.froschauer@kepleruniklinikum.at

Locations
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Austria
Kepler University Hospital Recruiting
Linz, Upper Austria, Austria, 4020
Contact: Stefan M Froschauer, MD    004373278061020    stefan.froschauer@kepleruniklinikum.at   
Principal Investigator: Stefan M Froschauer, MD         
Sub-Investigator: David Haslhofer, MD         
Sponsors and Collaborators
Kepler University Hospital
Investigators
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Study Director: Stefan M Froschauer, MD Kepler University Hospital Linz
More Information
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Responsible Party: Kepler University Hospital
ClinicalTrials.gov Identifier: NCT04655768    
Other Study ID Numbers: KUK-UNF-20-001
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kepler University Hospital:
radius fracture, clinical outcome
Additional relevant MeSH terms:
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Musculoskeletal Diseases
Radius Fractures
Fractures, Bone
 Wounds and Injuries
Forearm Injuries
Arm Injuries