Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Hemiarthroplasties

NCT ID: NCT00607516

Last Updated: 2009-06-24

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-01-31

Brief Summary

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Substudy and continuation of HEMI-SAB-UUS (NCT00491673)

Study on radiostereometric measurements of acetabular wear in bipolar hemiarthroplasties and measurements of periprosthetic bone mineral density in cemented and uncemented hemiarthroplasties in patients with femoral neck fractures.

Null hypothesis: No difference in acetabular wear or in bone mineral density changes between cemented and uncemented hemiarthroplasties

Detailed Description

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Patients are randomised to treatment with cemented or uncemented bipolar hemiarthroplasty. 1mm tantalum markers are inserted in the pelvis during surgery. RSA X-rays and DEXA measurements conducted postoperatively, after 3 and 12 months. Follow-up visits and clinical examination at 3 and 12 months.

Conditions

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Femoral Neck Fractures Bone Density Acetabular Wear Hemiarthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cemented

Cemented primary bipolar hemiarthroplasty of the hip

Group Type ACTIVE_COMPARATOR

Cemented primary bipolar hemiarthroplasty of the hip

Intervention Type PROCEDURE

Cemented primary bipolar hemiarthroplasty of the hip

Uncemented

Uncemented primary bipolar hemiarthroplasty of the hip

Group Type ACTIVE_COMPARATOR

Uncemented primary bipolar hemiarthroplasty of the hip

Intervention Type PROCEDURE

Uncemented primary bipolar hemiarthroplasty of the hip

Interventions

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Cemented primary bipolar hemiarthroplasty of the hip

Cemented primary bipolar hemiarthroplasty of the hip

Intervention Type PROCEDURE

Uncemented primary bipolar hemiarthroplasty of the hip

Uncemented primary bipolar hemiarthroplasty of the hip

Intervention Type PROCEDURE

Other Intervention Names

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Spectron, Smith & Nephew, Memphis, TN Corail, DePuy/Johnson and Johnson, United Kingdom

Eligibility Criteria

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Inclusion Criteria

* Femoral neck fracture
* 65 years or older
* Able to walk independently

Exclusion Criteria

* Cognitive dysfunction
* Infection
* Fracture caused by malignant disease
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ulleval university hospital

Principal Investigators

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Lars Nordsletten, Prof MD PhD

Role: STUDY_DIRECTOR

Ullevål University Hospital, University of Oslo

Locations

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Ullevål University Hospital

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

Other Identifiers

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REK I (Norway) 151-05-04061

Identifier Type: -

Identifier Source: secondary_id

HEMI-RSA-DEXA

Identifier Type: -

Identifier Source: org_study_id

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