Clinical trial NCT03427047: Comparing Surgical and Economical Parameters of Total Knee Replacement.
Official title: A Prospective, Randomized Study Comparing Surgical and Economic Parameters of Total Knee Replacement Performed Using Two Different Surgical Techniques: Medacta MyKnee® Surgical Technique Using Efficiency Single-use Instruments Versus Stryker Navigation Surgical Technique Performed With Conventional Metal Instruments.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Total Knee Arthroplasty
Lead sponsor: Medacta USA
Sponsor class: INDUSTRY
First posted: 2018-02-09
Enrollment: 82
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. MyKnee surgical technique patients will receive a CT scan of the surgical knee which enables custom manufacturing of the MyKnee cutting blocks. Stryker Navigational surgical technique patients will not require a CT scan. Both groups of patients will undergo total knee arthroplasty.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Compare Time-saving Associated With the Two Procedures.
timeFrame: Day of surgery
measure: Patient OR Time From Both Study Arms
timeFrame: Day of surgery
Secondary outcomes:
measure: Estimated Blood Loss From Both Study Arms
timeFrame: Day of surgery
measure: Baseline of Hemoglobin Both Study Arms
timeFrame: Baseline, 1 day post-op or at discharge from hospital
measure: Volume of Transfusions Both Study Arms
timeFrame: Day of surgery
measure: Instrument Trays Sent to Sterilization Both Study Arms
timeFrame: Day of surgery
measure: Amount of Waste From Surgery Both Study Arms
timeFrame: Day of surgery
measure: Baseline of Mechanical Axis Both Study Arms
timeFrame: Baseline, post-operative 6 weeks
measure: Change From Baseline of Tibial Slope Both Study Arms
timeFrame: Baseline, post-operative 6 weeks
measure: Related Complications
timeFrame: Baseline, day of surgery, post-op 6 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Methodist Sports Medicine Research & Education Foundation
state: Indiana
Study officials:
affiliation: Forte Sports Medicine and Orthopedics
name: John Hur, MD
role: PRINCIPAL_INVESTIGATOR
References: