Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy

March 5, 2019 updated by: Medacta International SA
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, CH-8092
        • Recruiting
        • Institute for Biomechanics ETH Zürich
        • Contact:
          • William Taylor
          • Phone Number: +41 44 632 2354

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

8-10 subjects with Medacta GMK Sphere TKA, 8-10 subjects with GMK PS Fixed Bearing TKA and 8-10 subjects with a GMK UC Fixed Bearing TKA will be involved in this project.

The subject recruitment will be based on the clinical reports of the follow-up examination including the standard clinical assessed parameters alignment, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the visual analog scale (VAS)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GMK Sphere
Patients who underwent total knee replacement using GMK Sphere implants. Patients underwent surgery before the inclusion in the study.
Other: Dynamic videofluoroscopic analysis
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.
Other: Dynamic videofluoroscopic analysis
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.
Other: Dynamic videofluoroscopic analysis
Patients bearing 3 different prosthesis (3 groups) will be prospactively assessed with videofluoroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2D/3D videofluoroscopy
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medacta International SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

July 1, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • P02.014.11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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