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Completed

NCT Number: NCT00800124

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

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.

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Key information

Conditions

Hip Fracture Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sykehuset Innlandet, Elverum

Elverum, Hedmark, 2407, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient or relative refuse enrollment

Treatment and study plan

cemented Landos prosthesis vs. uncemented Landos prosthesis

Procedure

randomization between the cemented and non-cemented prosthesis.

Other names: Titanium prosthesis, Corail uncemented prosthesis

Primary outcomes

  1. Mortality

    Time frame: 1 year after surgery

Sponsors and collaborators

Lead sponsor

Sykehuset Innlandet HF

Other

Collaborators

  • Rikshospitalet University Hospital
  • Sykehuset Buskerud HF

Registry information

Official study title

A Prospective Randomized Multicenter Study on Cemented and Non-cemented Hemiprosthesis in Older Patients With Dislocated Hip Fracture.

Acronym: CNC

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Dec 1, 2008
Registry last updated
Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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