search
Back to results

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

Primary Purpose

Orthopedic Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Palmar Plate Fixation
Sponsored by
Kepler University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopedic Disorder focused on measuring radius fracture, clinical outcome

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Radius Fractures C1-C2
  • age over 70

Exclusion Criteria:

  • demetia
  • collateral damages
  • age < 70

Sites / Locations

  • Kepler University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Operative Arm

Conservative Arm

Arm Description

Radius fractures C1/C2 treated by palmar plate fixation

Radius Fractures C1/C2 treated by cast fixation

Outcomes

Primary Outcome Measures

Patient Related Wrist Evaulation
PRWE, ROM investigation

Secondary Outcome Measures

ROM
PRWE, ROM, Investigation

Full Information

First Posted
November 30, 2020
Last Updated
August 19, 2022
Sponsor
Kepler University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04655768
Brief Title
Prospective Randomized Comparison of Conservative and Opertaive Treatment of Radius Fractures in Elderly Patients
Official Title
Prospective Randomized Comparison of Conservative and Opertaive Treatment of Radius Fractures in Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kepler University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder
Keywords
radius fracture, clinical outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Operative Arm
Arm Type
Active Comparator
Arm Description
Radius fractures C1/C2 treated by palmar plate fixation
Arm Title
Conservative Arm
Arm Type
No Intervention
Arm Description
Radius Fractures C1/C2 treated by cast fixation
Intervention Type
Device
Intervention Name(s)
Palmar Plate Fixation
Intervention Description
Patients are treated by surgery (palmar plate)
Primary Outcome Measure Information:
Title
Patient Related Wrist Evaulation
Description
PRWE, ROM investigation
Time Frame
12-24 months post intervention
Secondary Outcome Measure Information:
Title
ROM
Description
PRWE, ROM, Investigation
Time Frame
12-24 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Radius Fractures C1-C2 age over 70 Exclusion Criteria: demetia collateral damages age < 70
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan M Froschauer, MD
Phone
+4373278061020
Email
stefan.froschauer@kepleruniklinikum.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan M Froschauer, MD
Organizational Affiliation
Kepler University Hospital Linz
Official's Role
Study Director
Facility Information:
Facility Name
Kepler University Hospital
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan M Froschauer, MD
Phone
004373278061020
Email
stefan.froschauer@kepleruniklinikum.at
First Name & Middle Initial & Last Name & Degree
Stefan M Froschauer, MD
First Name & Middle Initial & Last Name & Degree
David Haslhofer, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs