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

Primary Purpose

Hip Fracture, Proximal Femoral Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Cemented semiendoprosthesis
non-cemented
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring Hip, Hip endoprosthesis, Hip fracture, Femoral fracture, Bone cement, Non-cemented

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A proximal femoral fracture

Exclusion Criteria:

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

Sites / Locations

  • Central Hospital of North Carelia
  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1 - cemented

2 - non-cemented

Arm Description

Patients are treated with a cemented semiendoprosthesis

Patients are treated with a non-cemented semiendoprosthesis

Outcomes

Primary Outcome Measures

Primary mortality

Secondary Outcome Measures

Prosthetic complications

Full Information

First Posted
March 10, 2009
Last Updated
April 3, 2015
Sponsor
Kuopio University Hospital
Collaborators
The Finnish Research Foundation for Orthopaedics and Traumatology
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1. Study Identification

Unique Protocol Identification Number
NCT00859378
Brief Title
Cemented vs Non-cemented Semiendoprosthesis in the Treatment of Proximal Femoral Fractures
Official Title
A Prospective, Randomized Study Comparing Cemented and Non-cemented Semiendoprostheses in the Treatment of Proximal Femoral Fractures in the Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
The Finnish Research Foundation for Orthopaedics and Traumatology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture, Proximal Femoral Fracture
Keywords
Hip, Hip endoprosthesis, Hip fracture, Femoral fracture, Bone cement, Non-cemented

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 - cemented
Arm Type
Active Comparator
Arm Description
Patients are treated with a cemented semiendoprosthesis
Arm Title
2 - non-cemented
Arm Type
Active Comparator
Arm Description
Patients are treated with a non-cemented semiendoprosthesis
Intervention Type
Device
Intervention Name(s)
Cemented semiendoprosthesis
Intervention Description
Application of a cemented semiendoprosthesis (Basis, Smith & Nephew)
Intervention Type
Device
Intervention Name(s)
non-cemented
Intervention Description
Patients are treated with a non-cemented semiendoprosthesis (Biomet Taperloc, Biomet Inc.)
Primary Outcome Measure Information:
Title
Primary mortality
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Prosthetic complications
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A proximal femoral fracture Exclusion Criteria: Rheumatoid arthritis Pathologic fracture Severe dementia (preventing the informed consent)
Facility Information:
Facility Name
Central Hospital of North Carelia
City
Joensuu
ZIP/Postal Code
80200
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70100
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

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

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