Prospactive Randomized Monocentric Comparison Study Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Kantonsspital Winterthur KSW
- Locations
- 2
- Primary Endpoint
- Change in Knee injury and Osteoarthritis Outcome Score
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in Knee injury and Osteoarthritis Outcome Score
Time Frame: 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
Time Frame: 1 year, 5 year and 10 year after surgery
Forgotten Joint Score: 100 = maximum score, 0 = minimum score
Secondary Outcomes
- 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)
Investigators
Peter Koch
Principal Investigator: PD/MD
Kantonsspital Winterthur KSW