Study on Cemented Versus Non-cemented Hemiarthroplasty in... | NCT00800124

Studies
Study on Cemented Versus Non-cemented Hemiarthroplasty in Elderly With Hip Fractures

NCT00800124

Sponsor

Sykehuset Innlandet HF

Status

Completed

Last Update Posted

Nov 24, 2014Estimated

Enrollment

334Actual

Phase

Not Applicable

Conditions

Hip Fracture

Interventions

cemented Landos prosthesis vs. uncemented Landos prosthesis

Countries

Norway

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

Nov 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Nov 27, 2008

First Submission Date that Met QC Criteria

Nov 28, 2008

First Posted Date

Dec 1, 2008Estimated

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

Nov 21, 2014

Last Update Posted Date

Nov 24, 2014Estimated

Name	Class
Rikshospitalet University Hospital	OTHER
Sykehuset Buskerud HF	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The objective is to study the overall frequency and cumulative rate (during one year) of clinical morbidity (defined as any hospitalization without fatal outcome) and mortality in all consecutive patients undergoing HF surgery (pins and prosthetic implants) and compare this to the group of patients receiving prosthetic implants and further find out if there is a difference between the non-cemented and cemented groups.

Between the same prosthetic groups, the investigators want to study the overall frequency of in-hospital subclinical organ damage and dysfunction of myocardium, liver and lungs, using biochemical plasma markers. Finally, the investigators want to perform perioperative cost benefit calculations and out of hospital quality of life analysis between the surgical groups.

Detailed Description

Not provided

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

334Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention	Cemented hemiprosthesis
2	Active Comparator	Non-cemented hemiprosthesis	Procedure: cemented Landos prosthesis vs. uncemented Landos prosthesis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cemented Landos prosthesis vs. uncemented Landos prosthesis	Procedure	randomization between the cemented and non-cemented prosthesis.	2

Measure	Description	Time Frame
Mortality		1 year after surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with Garden 3 or 4 fracture in acute hip fractures.
Age over 75 years.

Exclusion Criteria:

Patient or relative refuse enrollment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ove Talsnes, MD	Sykehsuet Innlandet, Elverum	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sykehuset Innlandet, Elverum		Elverum	Hedmark	2407	Norway

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

Browse Leaves

Not provided

Browse Branches

Not provided