Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy

NCT ID: NCT02828293

Last Updated: 2019-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Arthroplasty Replacement, Knee

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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GMK Sphere

Patients who underwent total knee replacement using GMK Sphere implants. Patients underwent surgery before the inclusion in the study.

Dynamic videofluoroscopic analysis

Intervention Type OTHER

Patients bearing 3 different prosthesis (3 groups) will be prospactively assessed with videofluoroscopy.

GMK PS Fixed Bearing

Patients who underwent total knee replacement using GMK PS Fixed Bearing implants. Patients underwent surgery before the inclusion in the study.

Dynamic videofluoroscopic analysis

Intervention Type OTHER

Patients bearing 3 different prosthesis (3 groups) will be prospactively assessed with videofluoroscopy.

GMK UC Fixed Bearing

Patients who underwent total knee replacement using GMK UC Fixed Bearing implants. Patients underwent surgery before the inclusion in the study.

Dynamic videofluoroscopic analysis

Intervention Type OTHER

Patients bearing 3 different prosthesis (3 groups) will be prospactively assessed with videofluoroscopy.

Interventions

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Dynamic videofluoroscopic analysis

Patients bearing 3 different prosthesis (3 groups) will be prospactively assessed with videofluoroscopy.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medacta International SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute for Biomechanics ETH Zurich

Zurich, , Switzerland

Site Status RECRUITING

Institute for Biomechanics ETH Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Facility Contacts

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Renate List

Role: primary

William Taylor

Role: primary

+41 44 632 2354

Other Identifiers

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P02.014.11

Identifier Type: -

Identifier Source: org_study_id

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