Prospective Randomized Comparison of Conservative and Ope... | NCT04655768

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

NCT04655768

Sponsor

Kepler University Hospital

Status

Unknown status

Last Update Posted

Aug 22, 2022Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Orthopedic Disorder

Interventions

Palmar Plate Fixation

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Nov 30, 2020

First Submission Date that Met QC Criteria

Nov 30, 2020

First Posted Date

Dec 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2022

Last Update Posted Date

Aug 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Palmar Plate Fixation	Device	Patients are treated by surgery (palmar plate)	Operative Arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Radius Fractures C1-C2
age over 70

Exclusion Criteria:

demetia
collateral damages
age < 70

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stefan M Froschauer, MD	Contact	+4373278061020		stefan.froschauer@kepleruniklinikum.at

Overall Officials

Name	Affiliation	Role
Stefan M Froschauer, MD	Kepler University Hospital Linz	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kepler University Hospital	Recruiting	Linz	Upper Austria	4020	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009140	Musculoskeletal Diseases
D011885	Radius Fractures

Ancestor Terms

ID	Term
D005543	Forearm Injuries
D001134	Arm Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone

Browse Leaves

Not provided

Browse Branches

Not provided