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NCT03130309 Clinical Trial

Results of a Mobile Unicompartimental Knee Prosthesis

Knee Replacement Clinical Trial

Official title:
Survival Rates of Atients Wearing a Mobile Unicompartimental Knee Prosthesis for the Past 10 Years

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03130309
Other study ID # 6756
Secondary ID
Status Recruiting
Phase
First received April 21, 2017
Last updated April 25, 2018
Start date May 1, 2017
Est. completion date May 2018

Study information
Verified date April 2017
Source University Hospital, Strasbourg, France
Contact Jean-Yves JENNY, MD, PhD
Phone 33.3.88.55.21.45
Email jean-yves.jenny@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The unicompartmental knee prosthesis 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 unicompartmental knee prosthesis with mobile plate for over 10 years, with the ones published in the literature for conventional fixed-bearing prostheses and mobile-bearing prostheses

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients over 18 years

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

Exclusion Criteria:

- Patients under 18 years

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre de Chirurgie Orthopédique et de la Main (CCOM) Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compare retrospectively data concerning survival rates of patients wearingunicompartmental knee prosthesis with mobile plate for over 10 years, with the ones published in the literature for conventional fixed and mobile bearing prosthesis. 10 years
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