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

Medacta

Status: Completed

Conditions: Osteoarthritis

Treatments: Device: Traditional Metal Instruments; Device: Customized patient instruments

Study type: Interventional

Funder types: Industry

Identifiers

NCT03148379

20161119

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Customized patient instruments

Experimental group

Description:

Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)

Treatment:

Device: Customized patient instruments

Traditional metal instruments

Active Comparator group

Description:

Control Group: Patients will undergo conventional surgical technique

Treatment:

Device: Traditional Metal Instruments