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A Clinical Evaluation of Wear Couples in THA

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00374946
First Posted: September 12, 2006
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Arne Borgwardt, Frederiksberg University Hospital
  Purpose
Clinical evaluation of 4 different bearings in THA. Primary parameter being prosthetic survival data.

Condition Intervention
Articular Bearing Surface Wear of Prosthetic Joint Wear of Articular Bearing Surface of Prosthetic Joint Prosthesis Survival Device: THA

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Randomised Controlled Clinical Study Ofbearing Surfaces in Four Hybrid Prosthesis - Results After 10 Years

Further study details as provided by Arne Borgwardt, Frederiksberg University Hospital:

Enrollment: 392
Study Start Date: December 2000
Study Completion Date: December 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
THA. Bearing of Zirconia head and UHMWPE liner
Device: THA
B
THA. Bearing of CO-Cr-Mo head and liner
Device: THA
C
THA. Head og Zirconia head and UHMWPE moulded in shell (Asian)
Device: THA
D
THA. Head and shell og Alumina ceramic
Device: THA

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients referred to the orthopedic department in the inclusion period fulfilling the inclusion criteria and not having any of the exclusion criteria
Criteria

Inclusion Criteria:

  • >18 Willing to participate informed consents indication for THA

Exclusion Criteria:

  • <18 other diseases in the lower extremities than the actual disorder of the hip
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00374946


Sponsors and Collaborators
Frederiksberg University Hospital
Investigators
Principal Investigator: Arne Borgwardt, md Frederiksberg UH
  More Information

Responsible Party: Arne Borgwardt, MD Head of Department, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT00374946     History of Changes
Obsolete Identifiers: NCT00289692
Other Study ID Numbers: KF-01-355/98
First Submitted: September 11, 2006
First Posted: September 12, 2006
Last Update Posted: March 24, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Prosthesis Failure
Postoperative Complications
Pathologic Processes


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