Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique

A Multi-center, Prospective, Randomized Study Comparing Surgical and Economic Parameters of Total Knee Replacement Performed With Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique.

To compare economic factors and the rate of adverse events between two types of instrumentation used for total knee replacement: Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®) Traditional Metal Instruments with Conventional Surgical Technique

Inclusion Criteria:

• Age 18 to 75 years
• BMI ≤35
• Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA)
• Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks

Exclusion Criteria:

• Pregnant women or those seeking to become pregnant. Pregnancy test is administered prior to surgery as part of routine care by the hospital / surgery center for all female patients of childbearing potential
• Is participating in another clinical study
• Has inflammatory arthritis
• Has knee avascular necrosis
• Has severe deformity, defined as greater than 10 degrees varus or valgus relative to the mechanical axis
• Has retained hardware in the knee that requires removal or interferes with Total Knee Arthroplasty (TKA) procedure