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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 12, 2005

Last Updated Date

August 4, 2006

Start Date ^†

January 2003

Current Primary Outcome Measures ^†

Migration of femoral components evaluated by RSA

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00120952 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Periprosthetic BMD changes evaluated by DEXA

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty. A Randomized Prospective Roentgen Stereogrammetric Analysis.

Brief Summary

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

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Osteoarthritis

Intervention ^†

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

October 2009

Primary Completion Date

Eligibility 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

Gender

Both

Ages

60 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Denmark

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00120952

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

University of Aarhus

Collaborators ^††

Investigators ^†

Study Chair:

Kjeld Søballe, MD, DMSc

Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark

Information Provided By

University of Aarhus

Verification Date

August 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.