NCT03896451

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

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
58mo left

Started Feb 2019

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Feb 2019Mar 2031

Study Start

First participant enrolled

February 2, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2031

Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

12.2 years

First QC Date

March 26, 2019

Last Update Submit

September 4, 2020

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • 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

  • Change in Forgotten Joint Score

    Forgotten Joint Score: 100 = maximum score, 0 = minimum score

    1 year, 5 year and 10 year after surgery

Secondary Outcomes (2)

  • Change in revison

    1 year, 5 year and 10 year after surgery

  • Change in range of motion

    preoperative, 1 year, 5 year and 10 year after surgery

Study Arms (2)

GMK Sphere

OTHER

Patients receiving total knee replacement surgery with the device "Medacta GMK Sphere"

Device: Total knee endoprothesis

GMK PS

OTHER

Patients receiving total knee replacement surgery with the device "Medacta GMK PS"

Device: Total knee endoprothesis

Interventions

Total knee endoprothesisDEVICE

Total knee endoprosthesis after knee joint osteoarthritis

GMK PSGMK Sphere

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patient is pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8400, Switzerland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Peter Koch, PD Dr. med.

    Principal Investigator

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator: PD/MD

Study Record Dates

First Submitted

March 26, 2019

First Posted

April 1, 2019

Study Start

February 2, 2019

Primary Completion (Estimated)

March 31, 2031

Study Completion (Estimated)

March 31, 2031

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)