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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00859378
Enrollment
400
Registered
2009-03-11
Start date
2008-10-31
Completion date
2015-12-31
Last updated
2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fracture, Proximal Femoral Fracture

Keywords

Hip, Hip endoprosthesis, Hip fracture, Femoral fracture, Bone cement, Non-cemented

Brief 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.

Interventions

DEVICECemented semiendoprosthesis

Application of a cemented semiendoprosthesis (Basis, Smith & Nephew)

DEVICEnon-cemented

Patients are treated with a non-cemented semiendoprosthesis (Biomet Taperloc, Biomet Inc.)

Sponsors

The Finnish Research Foundation for Orthopaedics and Traumatology
CollaboratorUNKNOWN
Kuopio University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* A proximal femoral fracture

Exclusion criteria

* Rheumatoid arthritis * Pathologic fracture * Severe dementia (preventing the informed consent)

Design outcomes

Primary

MeasureTime frame
Primary mortality3 months

Secondary

MeasureTime frame
Prosthetic complications1 year

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026