A Clinical Evaluation of Wear Couples in THA

March 22, 2017 updated by: Arne Borgwardt, Frederiksberg University Hospital

A Randomised Controlled Clinical Study Ofbearing Surfaces in Four Hybrid Prosthesis - Results After 10 Years

Clinical evaluation of 4 different bearings in THA. Primary parameter being prosthetic survival data.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

392

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Frederiksberg University Hospital

Investigators

  • Principal Investigator: Arne Borgwardt, md, Frederiksberg UH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 11, 2006

First Submitted That Met QC Criteria

September 11, 2006

First Posted (Estimate)

September 12, 2006

Study Record Updates

Last Update Posted (Actual)

March 24, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF-01-355/98

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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