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

NCT ID: NCT00859378

Last Updated: 2015-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Fracture Proximal Femoral Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 - cemented

Patients are treated with a cemented semiendoprosthesis

Group Type ACTIVE_COMPARATOR

Cemented semiendoprosthesis

Intervention Type DEVICE

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

2 - non-cemented

Patients are treated with a non-cemented semiendoprosthesis

Group Type ACTIVE_COMPARATOR

non-cemented

Intervention Type DEVICE

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

Interventions

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Cemented semiendoprosthesis

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

Intervention Type DEVICE

non-cemented

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* A proximal femoral fracture

Exclusion Criteria

* Rheumatoid arthritis
* Pathologic fracture
* Severe dementia (preventing the informed consent)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Finnish Research Foundation for Orthopaedics and Traumatology

UNKNOWN

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tero Yli-Kyyny

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Central Hospital of North Carelia

Joensuu, , Finland

Site Status

Kuopio University Hospital

Kuopio, , Finland

Site Status

Countries

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Finland

Other Identifiers

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KUH5203038

Identifier Type: -

Identifier Source: org_study_id

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