NCT04655768

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

November 30, 2020

Last Update Submit

August 19, 2022

Conditions

Orthopedic Disorder

Keywords

radius fracture, clinical outcome

Outcome Measures

Primary Outcomes (1)

  • Patient Related Wrist Evaulation

    PRWE, ROM investigation

    12-24 months post intervention

Secondary Outcomes (1)

  • ROM

    12-24 months post intervention

Study Arms (2)

Operative Arm

ACTIVE COMPARATOR

Radius fractures C1/C2 treated by palmar plate fixation

Device: Palmar Plate Fixation

Conservative Arm

NO INTERVENTION

Radius Fractures C1/C2 treated by cast fixation

Interventions

Palmar Plate FixationDEVICE

Patients are treated by surgery (palmar plate)

Operative Arm

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Radius Fractures C1-C2
  • age over 70

You may not qualify if:

  • demetia
  • collateral damages
  • age \< 70

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kepler University Hospital

Linz, Upper Austria, 4020, Austria

RECRUITING

MeSH Terms

Conditions

Musculoskeletal DiseasesRadius Fractures

Condition Hierarchy (Ancestors)

Forearm InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Stefan M Froschauer, MD

    Kepler University Hospital Linz

    STUDY DIRECTOR

Central Study Contacts

Stefan M Froschauer, MD

CONTACT

+4373278061020stefan.froschauer@kepleruniklinikum.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 7, 2020

Study Start

November 1, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

August 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)