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

NCT ID: NCT04655768

Last Updated: 2022-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Orthopedic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Operative Arm

Radius fractures C1/C2 treated by palmar plate fixation

Group Type ACTIVE_COMPARATOR

Palmar Plate Fixation

Intervention Type DEVICE

Patients are treated by surgery (palmar plate)

Conservative Arm

Radius Fractures C1/C2 treated by cast fixation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Palmar Plate Fixation

Patients are treated by surgery (palmar plate)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Radius Fractures C1-C2
* age over 70

Exclusion Criteria

* demetia
* collateral damages
* age \< 70
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kepler University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan M Froschauer, MD

Role: STUDY_DIRECTOR

Kepler University Hospital Linz

Locations

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Kepler University Hospital

Linz, Upper Austria, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Stefan M Froschauer, MD

Role: CONTACT

+4373278061020

Facility Contacts

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Stefan M Froschauer, MD

Role: primary

004373278061020

Other Identifiers

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KUK-UNF-20-001

Identifier Type: -

Identifier Source: org_study_id

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