NCT00800124

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 1, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2008

Enrollment Period

6 years

First QC Date

November 27, 2008

Last Update Submit

November 21, 2014

Conditions

Hip Fracture

Keywords

hip fracturehemiprosthesisbone cementclinical outcome

Outcome Measures

Primary Outcomes (1)

  • Mortality

    1 year after surgery

Study Arms (2)

1

NO INTERVENTION

Cemented hemiprosthesis

2

ACTIVE COMPARATOR

Non-cemented hemiprosthesis

Procedure: cemented Landos prosthesis vs. uncemented Landos prosthesis

Interventions

cemented Landos prosthesis vs. uncemented Landos prosthesisPROCEDURE

randomization between the cemented and non-cemented prosthesis.

Also known as: Titanium prosthesis, Corail uncemented prosthesis
2

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patient or relative refuse enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sykehuset Innlandet, Elverum

Elverum, Hedmark, 2407, Norway

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Ove Talsnes, MD

    Sykehsuet Innlandet, Elverum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2008

First Posted

December 1, 2008

Study Start

June 1, 2005

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

November 24, 2014

Record last verified: 2008-11

Locations

NO(1)