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

Not Applicable

Withdrawn

• Conditions: Knee Osteoarthritis
• Interventions: Device: Total knee endoprothesis

• Registration Number: NCT03896451
• Lead Sponsor: 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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-02-02
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-04-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-04
• Last Update Posted: 2020-09-09
• Primary Completion: 2031-03-31
• Study Completion: 2031-03-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• patient is pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GMK Sphere	Total knee endoprothesis	Patients receiving total knee replacement surgery with the device "Medacta GMK Sphere"
GMK PS	Total knee endoprothesis	Patients receiving total knee replacement surgery with the device "Medacta GMK PS"

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in revison	1 year, 5 year and 10 year after surgery	Revision rate comparision with the baseline at 1 year
Change in range of motion	preoperative, 1 year, 5 year and 10 year after surgery	Range of motion

Trial Locations

Locations (1)

Kantonsspital Winterthur; 🇨🇭 Winterthur, Zurich, Switzerland