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NCT02467699 Clinical Trial

Navigation System for in Vivo Measurement of the Kinematics of the Knee

Knee Osteoarthritis Clinical Trial

Official title:
Validation of a Noninvasive Navigation System for in Vivo Measurement of the Kinematics of the Knee

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02467699
Other study ID # 6158
Secondary ID
Status Recruiting
Phase N/A
First received May 14, 2015
Last updated May 18, 2017
Start date June 2015
Est. completion date September 2017

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

Clinical Trial Summary

The knee prosthesis is a validated treatment for end-stage osteoarthritis, and this intervention usually provides a significant improvement in the quality of life of patients. However, a significant percentage of patients (up 30%) say disappointed with the outcome of the intervention. One hypothesis that could explain these poor results might be poor adaptation of the implants to the patient's anatomy, resulting in a non-physiological kinematics for the patient. Multiple studies try to obtain an individual adaptation of the intervention according to multiple criteria. The measurement of the kinematics of the knee before surgery could participate in this process.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients over 18 years

- Patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total hip knee prosthesis.

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 in vivo measurement of the kinematics of the knee patient's medical data will be collected by health professional for the duration hospital stay, up to 1 year]
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