Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT03896451
Status:
WITHDRAWN
Last Update Posted:
2020-09-09
First Post:
2019-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS
Sponsor:
Kantonsspital Winterthur KSW
Organization:
Study Overview
Official Title:
Prospactive Randomized Monocentric Comparison Study Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS
Status:
WITHDRAWN
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Medacta GMK PS is not in use anymore
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: