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NCT02828293 Clinical Trial

Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy

Arthroplasty Clinical Trial

Official title:
Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02828293
Other study ID # P02.014.11
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2014
Est. completion date June 2019

Study information
Verified date September 2017
Source Medacta International SA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this research project is to perform a comparative study on the in vivo kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed Bearing TKA and the GMK UC Fixed Bearing TKA.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date June 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- subjects bearing a TKA with one of the studied prosthesis

- male and female older than 18 years old

- patients who are willing and able to sign an informed consent form

Exclusion Criteria:

- any case not described in the inclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Dynamic videofluoroscopic analysis
Patients bearing 3 different prosthesis (3 groups) will be prospactively assessed with videofluoroscopy.

Locations
Country Name City State
Switzerland Institute for Biomechanics ETH Zurich Zurich
Switzerland Institute for Biomechanics ETH Zurich Zurich

Sponsors (1)
Lead Sponsor Collaborator
Medacta International SA

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 2D/3D videofluoroscopy 1 year
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