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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02651571
Other study ID # 6267
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 4, 2016
Last updated June 16, 2016
Start date March 2016
Est. completion date March 2017

Study information

Verified date January 2016
Source University Hospital, Strasbourg, France
Contact Jean-Yves JENNY, MD
Phone 33.3.88.55.21.45
Email jean-yves.jenny@chru-strasbourg.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial Summary

The total knee replacement has become a routine procedure. Survival rate of over 90% after 10 years are generally reported. However, complications and reoperation may still occur for many reasons, and some of them may be related to component design: loosening (tibial above), polyethylene wear, knee stiffness, ligamentous instability, etc ... . Therefore, new designs can, at least in theory, improve the results of conventional models.

In this study, the investigators want to compare retrospectively data concerning survival rates of patients wearing total knee prosthesis with mobile plate for over 10 years, with the ones published in the literature for conventional fixed-bearing prostheses.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients over 18 years

- Patients wearing total knee prosthesis with mobile plate for over 10 years

Exclusion Criteria:

- Patients under 18 years

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Outcome

Type Measure Description Time frame Safety issue
Primary Compare retrospectively data concerning survival rates of patients wearing total knee prosthesis with mobile plate for over 10 years, with the ones published in the literature for conventional fixed-bearing prostheses. 10 years No
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