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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03896451
• Other study ID #: PS vs. Sphere
• Status: Withdrawn
• Phase: N/A
• Start date: February 2, 2019
• Est. completion date: March 31, 2031

Study information

• Verified date: September 2020
• Source: Kantonsspital Winterthur KSW
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2031
• Est. primary completion date: March 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Total knee endoprothesis
Total knee endoprosthesis after knee joint osteoarthritis

Locations

Country	Name	City	State
Switzerland	Kantonsspital Winterthur	Winterthur	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knee injury and Osteoarthritis Outcome Score	Knee injury and Osteoarthritis Outcome Score: 100 = maximum score, 0 = minimum score	preoperative, 1 year, 5 year and 10 year after surgery
Primary	Change in Forgotten Joint Score	Forgotten Joint Score: 100 = maximum score, 0 = minimum score	1 year, 5 year and 10 year after surgery
Secondary	Change in revison	Revision rate comparision with the baseline at 1 year	1 year, 5 year and 10 year after surgery
Secondary	Change in range of motion	Range of motion	preoperative, 1 year, 5 year and 10 year after surgery