Clinical trial NCT03148379: Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Total Knee Replacement
Lead sponsor: Medacta USA
Sponsor class: INDUSTRY
First posted: 2017-05-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: OR Total Time
timeFrame: Day of Surgery
measure: Opening Instruments
timeFrame: Day of Surgery
measure: Back Table Setup Time
timeFrame: Day of Surgery
measure: Tourniquet Time
timeFrame: Day of Surgery
measure: Incision to Skin Closure
timeFrame: Day of Surgery
measure: Bone Prep Time
timeFrame: Day of Surgery
measure: Patella Resection Time
timeFrame: Day of Surgery
measure: Clean-up Time
timeFrame: Day of Surgery
Secondary outcomes:
measure: Hemoglobin Range
timeFrame: 24 hours or at discharge if patient does not stay overnight
measure: Surgical Waste Weight
timeFrame: Day of Surgery
measure: Mechanical Axis
timeFrame: Pre-Operative
measure: Mechanical Axis
timeFrame: Post-Operative
measure: Tibial Slope
timeFrame: Pre-Operative
measure: Tibial Slope
timeFrame: Post-Operative
Other outcomes:
Locations:
city: Marrero
country: United States
facility: Tandem Clinical Research, LLC
state: Louisiana
city: Billings
country: United States
facility: Ortho Montana
state: Montana
city: Meadville
country: United States
facility: Orthopedic Associates Meadville
state: Pennsylvania
city: Austin
country: United States
facility: Texas Orthopedics
state: Texas
city: West Jordan
country: United States
facility: Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence
state: Utah
Study officials:
affiliation: Medacta USA
name: Mukesh Ahuja, MBBS, MS
role: STUDY_DIRECTOR
References: