NCT00859378

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

6.2 years

First QC Date

March 10, 2009

Last Update Submit

April 3, 2015

Conditions

Hip FractureProximal Femoral Fracture

Keywords

HipHip endoprosthesisHip fractureFemoral fractureBone cementNon-cemented

Outcome Measures

Primary Outcomes (1)

  • Primary mortality

    3 months

Secondary Outcomes (1)

  • Prosthetic complications

    1 year

Study Arms (2)

1 - cemented

ACTIVE COMPARATOR

Patients are treated with a cemented semiendoprosthesis

Device: Cemented semiendoprosthesis

2 - non-cemented

ACTIVE COMPARATOR

Patients are treated with a non-cemented semiendoprosthesis

Device: non-cemented

Interventions

Cemented semiendoprosthesisDEVICE

Application of a cemented semiendoprosthesis (Basis, Smith \& Nephew)

1 - cemented
non-cementedDEVICE

Patients are treated with a non-cemented semiendoprosthesis (Biomet Taperloc, Biomet Inc.)

2 - non-cemented

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A proximal femoral fracture

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Hospital of North Carelia

Joensuu, 80200, Finland

Location

Kuopio University Hospital

Kuopio, 70100, Finland

Location

MeSH Terms

Conditions

Hip FracturesProximal Femoral FracturesFemoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesFemoral Neck Fractures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 10, 2009

First Posted

March 11, 2009

Study Start

October 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

FI(2)