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

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ClinicalTrials.gov Identifier: NCT03896451
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Peter Koch, Kantonsspital Winterthur KSW

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Total knee endoprothesis Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Prospactive Randomized Monocentric Comparison Study Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS
Actual Study Start Date : February 2, 2019
Estimated Primary Completion Date : March 31, 2031
Estimated Study Completion Date : March 31, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Change in revison [ Time Frame: 1 year, 5 year and 10 year after surgery ]
    Revision rate comparision with the baseline at 1 year

  2. Change in range of motion [ Time Frame: preoperative, 1 year, 5 year and 10 year after surgery ]
    Range of motion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896451


Contacts
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Contact: Peter Koch, PD Dr. med. +41442662979 michel.schlaeppi@ksw.ch
Contact: Michel Schlaeppi, MSc +41442662996 michel.schlaeppi@ksw.ch

Locations
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Switzerland
Kantonsspital Winterthur Recruiting
Winterthur, Zurich, Switzerland, 8400
Contact: Michel Schlaeppi, MSc    +41 52 266 29 79    michel.schlaeppi@ksw.ch   
Contact: Peter Koch, PD Dr. med.    +41 52 266 29 96    peter.koch@ksw.ch   
Sponsors and Collaborators
Kantonsspital Winterthur KSW
Investigators
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Principal Investigator: Peter Koch, PD Dr. med. Principal Investigator

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Responsible Party: Peter Koch, Principal Investigator: PD/MD, Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier: NCT03896451     History of Changes
Other Study ID Numbers: PS vs. Sphere
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases