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

Primary Purpose

Hip Fracture

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
cemented Landos prosthesis vs. uncemented Landos prosthesis
Sponsored by
Sykehuset Innlandet HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring hip fracture, hemiprosthesis, bone cement, clinical outcome

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient or relative refuse enrollment

Sites / Locations

  • Sykehuset Innlandet, Elverum

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

1

2

Arm Description

Cemented hemiprosthesis

Non-cemented hemiprosthesis

Outcomes

Primary Outcome Measures

Mortality

Secondary Outcome Measures

Full Information

First Posted
November 27, 2008
Last Updated
November 21, 2014
Sponsor
Sykehuset Innlandet HF
Collaborators
Rikshospitalet University Hospital, Sykehuset Buskerud HF
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1. Study Identification

Unique Protocol Identification Number
NCT00800124
Brief Title
Study on Cemented Versus Non-cemented Hemiarthroplasty in Elderly With Hip Fractures
Acronym
CNC
Official Title
A Prospective Randomized Multicenter Study on Cemented and Non-cemented Hemiprosthesis in Older Patients With Dislocated Hip Fracture.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sykehuset Innlandet HF
Collaborators
Rikshospitalet University Hospital, Sykehuset Buskerud HF

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
hip fracture, hemiprosthesis, bone cement, clinical outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Cemented hemiprosthesis
Arm Title
2
Arm Type
Active Comparator
Arm Description
Non-cemented hemiprosthesis
Intervention Type
Procedure
Intervention Name(s)
cemented Landos prosthesis vs. uncemented Landos prosthesis
Other Intervention Name(s)
Titanium prosthesis, Corail uncemented prosthesis
Intervention Description
randomization between the cemented and non-cemented prosthesis.
Primary Outcome Measure Information:
Title
Mortality
Time Frame
1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ove Talsnes, MD
Organizational Affiliation
Sykehsuet Innlandet, Elverum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sykehuset Innlandet, Elverum
City
Elverum
State/Province
Hedmark
ZIP/Postal Code
2407
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

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