CClinicalTrials.gg
Status unknownNCT02828293Updated Mar 6, 2019

Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy

An observational study in Arthroplasty and Replacement, Knee, sponsored by Medacta International SA. Status unknown at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-06.

Sponsored by Medacta International SA · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Arthroplasty
  • Replacement, Knee
03

In context

Lead sponsor

Medacta International SA is the lead sponsor of 46 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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)

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

Exclusion Criteria:

  • any case not described in the inclusion criteria
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

Interventions

  • OtherDynamic videofluoroscopic analysis

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

06

What researchers measure

Primary outcomes

  1. 2D/3D videofluoroscopy

    Time frame: 1 year

07

Study locations

2 of 2 sites recruiting
  • Institute for Biomechanics ETH Zurich
    Zurich, CH-8092, Switzerland
    Recruiting
  • Institute for Biomechanics ETH Zurich
    Zurich, CH-8092, Switzerland
    • William Taylor · Contact · +41 44 632 2354
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02828293
Lead sponsor
Medacta International SA
Responsible party
Sponsor
First posted
Jul 11, 2016
Start date
Sep 2014
Primary completion
Jun 2019 (estimated)
Completion
Jun 2019 (estimated)
Last update
Mar 6, 2019
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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