Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

A Clinical Evaluation of Wear Couples in THA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arne Borgwardt, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT00374946
First received: September 11, 2006
Last updated: March 22, 2017
Last verified: March 2017
  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 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 11, 2006
Last Updated: March 22, 2017

Additional relevant MeSH terms:
Prosthesis Failure
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2017