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

Hip Fracture Clinical Trial

— CNC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800124
• Other study ID #: CNC2008
• Status: Completed
• Phase: N/A
• First received: November 27, 2008
• Last updated: November 21, 2014
• Start date: June 2005
• Est. completion date: June 2011

Study information

• Verified date: November 2008
• Source: Sykehuset Innlandet HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Patient with Garden 3 or 4 fracture in acute hip fractures.

• Age over 75 years.

Exclusion Criteria:

• Patient or relative refuse enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Procedure:
• cemented Landos prosthesis vs. uncemented Landos prosthesis
randomization between the cemented and non-cemented prosthesis.

Locations

Country	Name	City	State
Norway	Sykehuset Innlandet, Elverum	Elverum	Hedmark

Sponsors (3)

Lead Sponsor	Collaborator
Sykehuset Innlandet HF	Rikshospitalet University Hospital, Sykehuset Buskerud HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		1 year after surgery	Yes