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

This study is ongoing, but not recruiting participants.

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00120952

Purpose

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.

Condition	Intervention
Osteoarthritis	Device: Bi-Metric femoral implant (titanium versus cobalt-chromium)

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Metronidazole Metronidazole hydrochloride Metronidazole phosphate Chromium Cobalt

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty. A Randomized Prospective Roentgen Stereogrammetric Analysis.

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Migration of femoral components evaluated by RSA

Secondary Outcome Measures:

Periprosthetic BMD changes evaluated by DEXA

Estimated Enrollment:	40
Study Start Date:	January 2003
Estimated Study Completion Date:	October 2009

Eligibility

Ages Eligible for Study:	60 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120952

Locations

Denmark
Orthopaedic Department, Ribe County Hospital
Esbjerg, Denmark, 6700

Sponsors and Collaborators

University of Aarhus

Investigators

Study Chair:

Kjeld Søballe, MD, DMSc

Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark

More Information

Study ID Numbers:	M-2351-02
Study First Received:	July 12, 2005
Last Updated:	August 4, 2006
ClinicalTrials.gov Identifier:	NCT00120952
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

RSA
Osteoarthritis
Hip arthroplasty
DEXA

Titanium
Cobalt chromium
Bone cement

Study placed in the following topic categories:

Metronidazole
Chromium
Musculoskeletal Diseases
Osteoarthritis

Cobalt
Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009