NCT00374946

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
392

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2000

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2006

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

12.1 years

First QC Date

September 11, 2006

Last Update Submit

March 22, 2017

Conditions

Articular Bearing Surface Wear of Prosthetic JointWear of Articular Bearing Surface of Prosthetic JointProsthesis Survival

Study Arms (4)

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

Interventions

THADEVICE
ABCD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • \>18 Willing to participate informed consents indication for THA

You may not qualify if:

  • \<18 other diseases in the lower extremities than the actual disorder of the hip

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arne Borgwardt, md

    Frederiksberg UH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Head of Department

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 12, 2006

Study Start

December 1, 2000

Primary Completion

January 1, 2013

Study Completion

December 1, 2013

Last Updated

March 24, 2017

Record last verified: 2017-03