Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures.

NCT ID: NCT00746876

Last Updated: 2016-04-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-12-31

Brief Summary

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Hemiarthroplasty of the hip is standard treatment of femoral neck fractures (hip fractures). Hemiarthroplasty means replacing the hip joint with a metal prosthesis. Unipolar prostheses has a one-piece design where the hip movement occurs between the prosthesis and the acetabulum (hip socket). A bipolar prosthesis has an additional artificial joint between the two components of the prosthesis. Both treatments are clinically proven and common around the world. No clinical trial has proven benefits of one or the other prosthesis design. The investigators want to measure the differences in acetabular wear using these two prostheses, using radiostereometric measurements.

Detailed Description

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Patients 70 years or older presenting to our hospital with an acute femoral neck fracture are eligible for inclusion. 15 patients in each group will be recruited. One group receives a unipolar hemiarthroplasty and 15 receives a bipolar arthroplasty. Tantalum markers are placed around the acetabulum during surgery. Follow-up intervals are at 3, 12 and 24 months with radiostereometric evaluation (radiographs) and clinical evaluation.

Conditions

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Hip Fractures

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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Unipolar

15 patients randomized for treatment with a unipolar hip hemiarthroplasty

Group Type ACTIVE_COMPARATOR

Unipolar hip hemiarthroplasty

Intervention Type DEVICE

Unipolar hip hemiarthroplasty for the treatment of femoral neck fractures

Bipolar

15 patients randomized for treatment with a bipolar hip hemiarthroplasty

Group Type ACTIVE_COMPARATOR

Bipolar hip hemiarthroplasty

Intervention Type DEVICE

Bipolar hip hemiarthroplasty for the treatment of femoral neck fractures

Interventions

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Unipolar hip hemiarthroplasty

Unipolar hip hemiarthroplasty for the treatment of femoral neck fractures

Intervention Type DEVICE

Bipolar hip hemiarthroplasty

Bipolar hip hemiarthroplasty for the treatment of femoral neck fractures

Intervention Type DEVICE

Other Intervention Names

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Modular Cathcart Unipolar, DePuy/Johnson and Johnson Celf-Centering Bipolar, DePuy/Johnson and Johnson

Eligibility Criteria

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Inclusion Criteria

* Displaced femoral neck fracture
* 70 years or older
* Ambulatory status: No walking aids
* No mental illness or impaired cognitive function

Exclusion Criteria

* Pathological fracture (malignant disease)
* Ongoing systemic or local infection
* Radiologically presence of acetabular wear (osteoarthrosis)
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role collaborator

Sykehuset Asker og Baerum

OTHER

Sponsor Role lead

Responsible Party

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Wender Figved

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asbjørn Hjall, M.D.

Role: STUDY_DIRECTOR

Asker and Baerum hospital, Norway

Locations

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Asker and Baerum Hospital

Baerum, Rud, Norway

Site Status

Countries

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Norway

Other Identifiers

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HEMI-UNI-BIPOL

Identifier Type: -

Identifier Source: org_study_id

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