Status:
COMPLETED
Comparing Surgical and Economical Parameters of Total Knee Replacement.
Lead Sponsor:
Medacta USA
Conditions:
Osteo Arthritis Knee
Total Knee Arthroplasty
Eligibility:
All Genders
16-75 years
Phase:
NA
Brief Summary
Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty performed using two different specific surgical techniques.
Detailed Description
Randomized 1: ratio study comparing Medacta MyKnee surgical technique using Efficiency single use instruments versus Stryker Navigation surgical techniques performed with conventional instruments. MyK...
Eligibility Criteria
Inclusion
- Age 18 to 75 years 2) BMI ≤35 3) Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA) with the Medacta GMK Sphere 4) Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks
Exclusion
- Is participating in another clinical study 2) Has inflammatory arthritis 3) Has knee avascular necrosis 4) Has severe deformity, defined as greater than 15 degrees varus or 10 degrees valgus relative to the mechanical axis. 5) Has retained hardware in the knee that requires removal and interferes with TKA procedure 6) Has prior high tibial osteotomy (HTO)
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT03427047
Start Date
August 1 2018
End Date
January 1 2022
Last Update
June 13 2023
Active Locations (1)
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1
Methodist Sports Medicine Research & Education Foundation
Indianapolis, Indiana, United States, 46280