A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Completion Date

2010-01-31

Brief Summary

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In this randomised study, the migration of a specific cemented titanium femoral stem will be compared with a similar cemented cobalt-chromium stem using Roentgen stereogrammetric analysis (RSA). In addition, the periprosthetic bone mineral density (BMD) will be evaluated to point out any interference from the modulus of the stem investigated.

Detailed Description

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Conditions

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Osteoarthritis

Keywords

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RSA Osteoarthritis Hip arthroplasty DEXA Titanium Cobalt chromium Bone cement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bi-Metric femoral implant (titanium versus cobalt-chromium)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Primary osteoarthritis of the hip
* Spinal anesthesia
* Informed written consent

Exclusion Criteria

* Neuromuscular disease in the affected leg
* Vascular disease in the affected leg
* Fracture sequelae in the affected hip
* Weight over 100 kg
* Regular non-steroid anti-inflammatory drug (NSAID) intake in the postoperative period

Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Kjeld Søballe, MD, DMSc

Role: STUDY_CHAIR

Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark

Locations

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Orthopaedic Department, Ribe County Hospital

Esbjerg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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M-2351-02

Identifier Type: -

Identifier Source: org_study_id