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

April 3, 2015 updated by: Tero Yli-Kyyny, Kuopio University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Joensuu, Finland, 80200
        • Central Hospital of North Carelia
      • Kuopio, Finland, 70100
        • Kuopio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A proximal femoral fracture

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary mortality
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Prosthetic complications
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

The Finnish Research Foundation for Orthopaedics and Traumatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

March 10, 2009

First Posted (ESTIMATE)

March 11, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 3, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5203038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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