Comparison Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS

September 4, 2020 updated by: Peter Koch, Kantonsspital Winterthur KSW

Prospactive Randomized Monocentric Comparison Study Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS

The purpose of the study is to compare the clinical outcome after two total knee endoprosthesis designs Medacta GMK Sphere and Medacta GMK PS.

Primary outcome measures KOOS, Forgotten Knee Score and range of motion.

Single-center, randomized trial

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The clinical outcome measures were measured preoperativ and postoperativ (1 year, 5 year and 10 year).

Secondary outcome measures: number of reoperations and revisions, survival of the prosthesis

The patient population would consist patients with knee osteoarthritis eligible for total knee replacement

The aim of the study is to evaluate the effect of the knee prosthesis design on the patient outcome

Study Type

Interventional

Phase

  • Not Applicable

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
      • Winterthur, Zurich, Switzerland, 8400
        • Kantonsspital Winterthur

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

Description

Inclusion Criteria:

  • patient is eligible for a total knee replacement
  • patient is eligible for a Medacta GMK Sphere or Medacta GMK PS knee prosthesis
  • patient signed the informed consent

Exclusion Criteria:

  • patient is pregnant

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

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: GMK Sphere
Patients receiving total knee replacement surgery with the device "Medacta GMK Sphere"
Device: Total knee endoprothesis
Total knee endoprosthesis after knee joint osteoarthritis
OTHER: GMK PS
Patients receiving total knee replacement surgery with the device "Medacta GMK PS"
Device: Total knee endoprothesis
Total knee endoprosthesis after knee joint osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Knee injury and Osteoarthritis Outcome Score
Time Frame: preoperative, 1 year, 5 year and 10 year after surgery
Knee injury and Osteoarthritis Outcome Score: 100 = maximum score, 0 = minimum score
preoperative, 1 year, 5 year and 10 year after surgery
Change in Forgotten Joint Score
Time Frame: 1 year, 5 year and 10 year after surgery
Forgotten Joint Score: 100 = maximum score, 0 = minimum score
1 year, 5 year and 10 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in revison
Time Frame: 1 year, 5 year and 10 year after surgery
Revision rate comparision with the baseline at 1 year
1 year, 5 year and 10 year after surgery
Change in range of motion
Time Frame: preoperative, 1 year, 5 year and 10 year after surgery
Range of motion
preoperative, 1 year, 5 year and 10 year after surgery

Collaborators and Investigators

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

Sponsor

Kantonsspital Winterthur KSW

Investigators

  • Principal Investigator: Peter Koch, PD Dr. med., Principal Investigator

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 (ACTUAL)

February 2, 2019

Primary Completion (ANTICIPATED)

March 31, 2031

Study Completion (ANTICIPATED)

March 31, 2031

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

March 28, 2019

First Posted (ACTUAL)

April 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 4, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS vs. Sphere

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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