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A Clinical Evaluation of Wear Couples in THA

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ClinicalTrials.gov Identifier: NCT00374946
Recruitment Status : Completed
First Posted : September 12, 2006
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Clinical evaluation of 4 different bearings in THA. Primary parameter being prosthetic survival data.

Condition or disease Intervention/treatment
Articular Bearing Surface Wear of Prosthetic Joint Wear of Articular Bearing Surface of Prosthetic Joint Prosthesis Survival Device: THA

Study Design

Study Type : Observational
Actual Enrollment : 392 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Randomised Controlled Clinical Study Ofbearing Surfaces in Four Hybrid Prosthesis - Results After 10 Years
Study Start Date : December 2000
Primary Completion Date : January 2013
Study Completion Date : December 2013
Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Eligibility Criteria

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 Posted: September 12, 2006    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Prosthesis Failure
Postoperative Complications
Pathologic Processes