Overview

This trial is active, not recruiting.

Conditions hip fracture, proximal femoral fracture
Treatments cemented semiendoprosthesis, non-cemented
Sponsor Kuopio University Hospital
Collaborator The Finnish Research Foundation for Orthopaedics and Traumatology
Start date October 2008
End date December 2014
Trial size 400 participants
Trial identifier NCT00859378, KUH5203038

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients are treated with a cemented semiendoprosthesis
cemented semiendoprosthesis
Application of a cemented semiendoprosthesis (Basis, Smith & Nephew)
(Active Comparator)
Patients are treated with a non-cemented semiendoprosthesis
non-cemented
Patients are treated with a non-cemented semiendoprosthesis (Biomet Taperloc, Biomet Inc.)

Primary Outcomes

Measure
Primary mortality
time frame: 3 months

Secondary Outcomes

Measure
Prosthetic complications
time frame: 1 year

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - A proximal femoral fracture Exclusion Criteria: - Rheumatoid arthritis - Pathologic fracture - Severe dementia (preventing the informed consent)

Additional Information

Official title A Prospective, Randomized Study Comparing Cemented and Non-cemented Semiendoprostheses in the Treatment of Proximal Femoral Fractures in the Elderly Patients
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Kuopio University Hospital.