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NCT02019862 Clinical Trial

TRJ Post Market Clinical Follow Up

Total Hip Arthroplasty Clinical Trial

Official title:
TRJ PMCF Köln: 2-years Results

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02019862
Other study ID # AAG-O-H-1314
Secondary ID
Status Completed
Phase N/A
First received December 4, 2013
Last updated April 15, 2015
Start date January 2014
Est. completion date February 2015

Study information
Verified date April 2015
Source Aesculap AG
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Clinical and radiological 2 years results of TRJ® Hip Stem.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion:

- TRJ® implantation performed

- patient consent available for participation in the study

Exclusion:

- permanent cortisone therapy

- alcohol or drug abuse

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Device:
• TRJ® Total Hip Arthroplasty

Locations
Country Name City State
Germany Dreifaltigkeitskrankenhaus Köln Köln

Sponsors (1)
Lead Sponsor Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Implant Survival 24 months No
Secondary Clinical Outcome Harris Hip Score 24 months No
Secondary Osteolysis Radiological Outcome 24 months No
Secondary Ossification Radiological Outcome 24 months No
Secondary Migration Radiological Outcome 24 months No
Secondary TRJ® Implant Position Radiological Outcome 24 months No
See also
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