NCT02828293

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

March 6, 2019

Status Verified

September 1, 2017

Enrollment Period

4.8 years

First QC Date

July 1, 2016

Last Update Submit

March 5, 2019

Conditions

ArthroplastyReplacement, Knee

Outcome Measures

Primary Outcomes (1)

  • 2D/3D videofluoroscopy

    1 year

Study Arms (3)

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

Dynamic videofluoroscopic analysisOTHER

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

GMK PS Fixed BearingGMK SphereGMK UC Fixed Bearing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute for Biomechanics ETH Zurich

Zurich, CH-8092, Switzerland

RECRUITING

Institute for Biomechanics ETH Zurich

Zurich, CH-8092, Switzerland

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2016

First Posted

July 11, 2016

Study Start

September 1, 2014

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

March 6, 2019

Record last verified: 2017-09

Locations

CH(2)