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

This study has been completed.
Sponsor:
Collaborators:
Rikshospitalet University Hospital
Sykehuset Buskerud HF
Information provided by (Responsible Party):
Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:
NCT00800124
First received: November 27, 2008
Last updated: November 21, 2014
Last verified: November 2008
  Purpose

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 Intervention
Hip Fracture
Procedure: cemented Landos prosthesis vs. uncemented Landos prosthesis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Sykehuset Innlandet HF:

Primary Outcome Measures:
  • Mortality [ Time Frame: 1 year after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 334
Study Start Date: June 2005
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT00800124     History of Changes
Other Study ID Numbers: CNC2008
Study First Received: November 27, 2008
Last Updated: November 21, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on November 25, 2014