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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Tero Yli-Kyyny, Kuopio University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00859378
First Posted: March 11, 2009
Last Update Posted: April 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Finnish Research Foundation for Orthopaedics and Traumatology
Information provided by (Responsible Party):
Tero Yli-Kyyny, Kuopio University Hospital
  Purpose
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.

Condition Intervention
Hip Fracture Proximal Femoral Fracture Device: Cemented semiendoprosthesis Device: non-cemented

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study Comparing Cemented and Non-cemented Semiendoprostheses in the Treatment of Proximal Femoral Fractures in the Elderly Patients

Resource links provided by NLM:


Further study details as provided by Tero Yli-Kyyny, Kuopio University Hospital:

Primary Outcome Measures:
  • Primary mortality [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Prosthetic complications [ Time Frame: 1 year ]

Estimated Enrollment: 400
Study Start Date: October 2008
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 - cemented
Patients are treated with a cemented semiendoprosthesis
Device: Cemented semiendoprosthesis
Application of a cemented semiendoprosthesis (Basis, Smith & Nephew)
Active Comparator: 2 - non-cemented
Patients are treated with a non-cemented semiendoprosthesis
Device: non-cemented
Patients are treated with a non-cemented semiendoprosthesis (Biomet Taperloc, Biomet Inc.)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A proximal femoral fracture

Exclusion Criteria:

  • Rheumatoid arthritis
  • Pathologic fracture
  • Severe dementia (preventing the informed consent)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859378


Locations
Finland
Central Hospital of North Carelia
Joensuu, Finland, 80200
Kuopio University Hospital
Kuopio, Finland, 70100
Sponsors and Collaborators
Kuopio University Hospital
The Finnish Research Foundation for Orthopaedics and Traumatology
  More Information

Responsible Party: Tero Yli-Kyyny, M.D., Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00859378     History of Changes
Other Study ID Numbers: KUH5203038
First Submitted: March 10, 2009
First Posted: March 11, 2009
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by Tero Yli-Kyyny, Kuopio University Hospital:
Hip
Hip endoprosthesis
Hip fracture
Femoral fracture
Bone cement
Non-cemented

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Femoral Fractures
Wounds and Injuries
Hip Injuries
Leg Injuries