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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 10
- Primary Endpoint
- Tourniquet Time
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 18 to 75 years
- •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
Outcomes
Primary Outcomes
Tourniquet Time
Time Frame: Day of Surgery
Time tourniquet is on patient during surgery
OR Total Time
Time Frame: Day of Surgery
Total time patient is in operating room
Opening Instruments
Time Frame: Day of Surgery
Time to open surgical instruments
Back Table Setup Time
Time Frame: Day of Surgery
Time to set up back surgical table
Incision to Skin Closure
Time Frame: Day of Surgery
Time from incision to skin closure during surgery
Patella Resection Time
Time Frame: Day of Surgery
Time to resection patella during surgery
Bone Prep Time
Time Frame: Day of Surgery
Time to prepare bone for implant during surgery
Clean-up Time
Time Frame: Day of Surgery
Time to clean up following surgery
Secondary Outcomes
- Mechanical Axis(Post-Operative)
- Tibial Slope(Post-Operative)
- Hemoglobin Range(24 hours or at discharge if patient does not stay overnight)
- Surgical Waste Weight(Day of Surgery)