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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Finnish Research Foundation for Orthopaedics and Traumatology
Information provided by (Responsible Party):
Tero Yli-Kyyny, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00859378
First received: March 10, 2009
Last updated: August 12, 2013
Last verified: August 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Kuopio University Hospital:

Primary Outcome Measures:
  • Primary mortality [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Prosthetic complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: October 2008
Estimated Study Completion Date: December 2014
Estimated 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Tero Yli-Kyyny, M.D., Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00859378     History of Changes
Other Study ID Numbers: KUH5203038
Study First Received: March 10, 2009
Last Updated: August 12, 2013
Health Authority: Finland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 23, 2014