Back to resultsComparison Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS
Primary Purpose
Knee Osteoarthritis
Status
Withdrawn
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Total knee endoprothesis
Sponsored by
About this trial
This is an interventional screening trial for Knee Osteoarthritis
Eligibility 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
Sites / Locations
- Kantonsspital Winterthur
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
GMK Sphere
GMK PS
Arm Description
Patients receiving total knee replacement surgery with the device "Medacta GMK Sphere"
Patients receiving total knee replacement surgery with the device "Medacta GMK PS"
Outcomes
Primary Outcome Measures
Change in Knee injury and Osteoarthritis Outcome Score
Knee injury and Osteoarthritis Outcome Score: 100 = maximum score, 0 = minimum score
Change in Forgotten Joint Score
Forgotten Joint Score: 100 = maximum score, 0 = minimum score
Secondary Outcome Measures
Change in revison
Revision rate comparision with the baseline at 1 year
Change in range of motion
Range of motion
Full Information
NCT ID
NCT03896451
First Posted
March 26, 2019
Last Updated
September 4, 2020
Sponsor
Kantonsspital Winterthur KSW
1. Study Identification
Unique Protocol Identification Number
NCT03896451
Brief Title
Comparison Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS
Official Title
Prospactive Randomized Monocentric Comparison Study Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Medacta GMK PS is not in use anymore
Study Start Date
February 2, 2019 (Actual)
Primary Completion Date
March 31, 2031 (Anticipated)
Study Completion Date
March 31, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kantonsspital Winterthur KSW
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GMK Sphere
Arm Type
Other
Arm Description
Patients receiving total knee replacement surgery with the device "Medacta GMK Sphere"
Arm Title
GMK PS
Arm Type
Other
Arm Description
Patients receiving total knee replacement surgery with the device "Medacta GMK PS"
Intervention Type
Device
Intervention Name(s)
Total knee endoprothesis
Intervention Description
Total knee endoprosthesis after knee joint osteoarthritis
Primary Outcome Measure Information:
Title
Change in Knee injury and Osteoarthritis Outcome Score
Description
Knee injury and Osteoarthritis Outcome Score: 100 = maximum score, 0 = minimum score
Time Frame
preoperative, 1 year, 5 year and 10 year after surgery
Title
Change in Forgotten Joint Score
Description
Forgotten Joint Score: 100 = maximum score, 0 = minimum score
Time Frame
1 year, 5 year and 10 year after surgery
Secondary Outcome Measure Information:
Title
Change in revison
Description
Revision rate comparision with the baseline at 1 year
Time Frame
1 year, 5 year and 10 year after surgery
Title
Change in range of motion
Description
Range of motion
Time Frame
preoperative, 1 year, 5 year and 10 year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Koch, PD Dr. med.
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Winterthur
City
Winterthur
State/Province
Zurich
ZIP/Postal Code
8400
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS
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