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

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ClinicalTrials.gov Identifier: NCT00800124
Recruitment Status : Completed
First Posted : December 1, 2008
Last Update Posted : November 24, 2014
Sponsor:
Collaborators:
Rikshospitalet University Hospital
Sykehuset Buskerud HF
Information provided by (Responsible Party):
Sykehuset Innlandet HF

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.


Condition or disease Intervention/treatment Phase
Hip Fracture Procedure: cemented Landos prosthesis vs. uncemented Landos prosthesis Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Multicenter Study on Cemented and Non-cemented Hemiprosthesis in Older Patients With Dislocated Hip Fracture.
Study Start Date : June 2005
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1
Cemented hemiprosthesis
Active Comparator: 2
Non-cemented hemiprosthesis
Procedure: cemented Landos prosthesis vs. uncemented Landos prosthesis
randomization between the cemented and non-cemented prosthesis.
Other Names:
  • Titanium prosthesis
  • Corail uncemented prosthesis



Primary Outcome Measures :
  1. Mortality [ Time Frame: 1 year after surgery ]


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Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800124


Locations
Norway
Sykehuset Innlandet, Elverum
Elverum, Hedmark, Norway, 2407
Sponsors and Collaborators
Sykehuset Innlandet HF
Rikshospitalet University Hospital
Sykehuset Buskerud HF
Investigators
Principal Investigator: Ove Talsnes, MD Sykehsuet Innlandet, Elverum

Responsible Party: Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT00800124     History of Changes
Other Study ID Numbers: CNC2008
First Posted: December 1, 2008    Key Record Dates
Last Update Posted: November 24, 2014
Last Verified: November 2008

Keywords provided by Sykehuset Innlandet HF:
hip fracture
hemiprosthesis
bone cement
clinical outcome

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries