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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Sykehuset Innlandet HF.
Recruitment status was  Active, not recruiting
Rikshospitalet University Hospital
Sykehuset Buskerud HF
Information provided by:
Sykehuset Innlandet HF Identifier:
First received: November 27, 2008
Last updated: August 11, 2010
Last verified: November 2008

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 ]

Estimated Enrollment: 300
Study Start Date: June 2005
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: September 2010 (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


Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00800124

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

No publications provided

Responsible Party: Ove Talsnes, consultant surgeon SIHF Elverum, department of Orthopaedic Surgery, SIHF, Elverum, Norway Identifier: NCT00800124     History of Changes
Other Study ID Numbers: CNC2008, REK S-04078
Study First Received: November 27, 2008
Last Updated: August 11, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries
Wounds and Injuries processed this record on October 30, 2014