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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00859378
Other study ID # KUH5203038
Secondary ID
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


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
See also
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Terminated NCT01667913 - Reliability of 6-Minutes Walking Test in Hip Fracture Patients N/A
Completed NCT01714336 - Does Tranexamic Acid Reduce the Need for Blood Transfusions in Patients Undergoing Hip Fracture Surgery? Phase 4
Terminated NCT01535781 - Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced? N/A
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Active, not recruiting NCT02362971 - External Validity of a Randomized Trial in Patients With a Femoral Neck Fracture N/A
Completed NCT02591342 - Comparison of a Cemented, Polished Tapered Stem and an Anatomic Stem for Femoral Neck Fracture N/A
Completed NCT01738776 - Nutritional Risk Factors for Hip Fracture: a Case Control Study N/A
Completed NCT01382875 - The Comparison of Comprehensive Multi-disciplinary Program and Conventional Care Program on Fragility Fracture Elderly Phase 3
Suspended NCT00521716 - Safety and Efficacy of the WaisFix100i for Intracapsular Femoral Fracture Fixation N/A
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Active, not recruiting NCT00345488 - Fast Track Admittance of Hip Fracture Patients Phase 4
Completed NCT02409082 - Alzheimers Disease and Neuromarkers in Patients With Acute Hip Fractures N/A
Recruiting NCT04626934 - Cognitive Intervention and Rehabilitation Outcomes in Hip Fracture Patients N/A
Completed NCT06001996 - Comparison of Intraoperative- Postoperative Effects of Pericapsular Nerve Block and Fascia Iliaca Block in Hip Fracture
Recruiting NCT02635763 - Peripheral Nerve Blocks in Elderly Patients With Hip Fracture N/A
Completed NCT02190903 - A Trial To Assess Risk of Delirium in Older Adults Undergoing Hip Fracture Surgery With Spinal or General Anesthesia N/A
Completed NCT00848913 - Strength Training After Hip Fracture Surgery N/A