Cemented vs Non-cemented Semiendoprosthesis in the Treatment of Proximal Femoral Fractures

Hip Fracture Clinical Trial

Official title:

A Prospective, Randomized Study Comparing Cemented and Non-cemented Semiendoprostheses in the Treatment of Proximal Femoral Fractures in the Elderly Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00859378
• Other study ID #: KUH5203038
• Status: Active, not recruiting
• Phase: N/A
• First received: March 10, 2009
• Last updated: April 3, 2015
• Start date: October 2008
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The hip semiendoprosthesis is an acceptable method to treat the proximal femoral fractures. Traditionally, the cemented version of the semiendoprosthesis has been used for this indication. However, the cementing carries a risk of fat embolism during the pressurization of the cement. The fat embolism can be avoided when using the non-cemented semiendoprosthesis. In this study we want to find out whether there are any differences in the treatment results between the cemented and non-cemented semiendoprostheses when treating the proximal femoral fractures.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• A proximal femoral fracture

Exclusion Criteria:

• Rheumatoid arthritis

• Pathologic fracture

• Severe dementia (preventing the informed consent)

Study Design

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

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Hip Fracture
• Hip Fractures
• Proximal Femoral Fracture

Intervention

Device:
• Cemented semiendoprosthesis
Application of a cemented semiendoprosthesis (Basis, Smith & Nephew)
• non-cemented
Patients are treated with a non-cemented semiendoprosthesis (Biomet Taperloc, Biomet Inc.)

Locations

Country	Name	City	State
Finland	Central Hospital of North Carelia	Joensuu
Finland	Kuopio University Hospital	Kuopio

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	The Finnish Research Foundation for Orthopaedics and Traumatology

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary mortality		3 months	Yes
Secondary	Prosthetic complications		1 year	Yes