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

NCT ID: NCT00800124

Last Updated: 2014-11-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Hip Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Cemented hemiprosthesis

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Non-cemented hemiprosthesis

Group Type ACTIVE_COMPARATOR

cemented Landos prosthesis vs. uncemented Landos prosthesis

Intervention Type PROCEDURE

randomization between the cemented and non-cemented prosthesis.

Interventions

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cemented Landos prosthesis vs. uncemented Landos prosthesis

randomization between the cemented and non-cemented prosthesis.

Intervention Type PROCEDURE

Other Intervention Names

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Titanium prosthesis Corail uncemented prosthesis

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patient or relative refuse enrollment
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rikshospitalet University Hospital

OTHER

Sponsor Role collaborator

Sykehuset Buskerud HF

OTHER

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ove Talsnes, MD

Role: PRINCIPAL_INVESTIGATOR

Sykehsuet Innlandet, Elverum

Locations

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Sykehuset Innlandet, Elverum

Elverum, Hedmark, Norway

Site Status

Countries

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Norway

Other Identifiers

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CNC2008

Identifier Type: -

Identifier Source: org_study_id