Comparing Surgical and Economical Parameters of Total Knee Replacement.

Study Overview
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Brief Summary
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Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty performed using two different specific surgical techniques.

Detailed Description
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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.

Official Title
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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.

Conditions
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Osteo Arthritis Knee, Total Knee Arthroplasty

Intervention / Treatment
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* Device: MyKnee with single use Efficiency Instrument
* Device: Stryker Navigational with conventional metal instruments


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MyKnee with single use Efficiency Instrument<br>Patients randomized in this group will undergo Total Knee Arthroplasty utilizing patient matched cutting blocks and single use instruments. Customization will be by a CT scan of patients knee. | Device: MyKnee with single use Efficiency Instrument<br>* Total Knee Arthroplasty utilizing a CT scan for customization of cutting blocks with single use instrumentation<br>|
| Active Comparator: Stryker Navigational with conventional metal instruments<br>Patients randomized in this group will undergo Total Knee Arthroplasty with conventional metal instruments. CT scan are not utilized with this arm. | Device: Stryker Navigational with conventional metal instruments<br>* Total Knee Arthroplasty without customization of cutting blocks using conventional metal instruments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Time-saving Associated With the Two Procedures. | Measure clean up time at end of surgery in minutes | Day of surgery | 
| Patient OR Time From Both Study Arms | Measure skin to skin, tourniquet time and femoral and tibial resection time in minutes | Day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Blood Loss From Both Study Arms | Volume of estimated blood loss in cc's | Day of surgery | 
| Baseline of Hemoglobin Both Study Arms | Measure in grams per deciliter | Baseline, 1 day post-op or at discharge from hospital | 
| Volume of Transfusions Both Study Arms | Measure amount of blood patient receives in ML | Day of surgery | 
| Instrument Trays Sent to Sterilization Both Study Arms | Record number of trays sent to be sterilized | Day of surgery | 
| Amount of Waste From Surgery Both Study Arms | Combined weight of recyclable and non-recyclable waste in grams | Day of surgery | 
| Baseline of Mechanical Axis Both Study Arms | Determine radiographic analysis by measuring knee mechanical axis in degrees | Baseline, post-operative 6 weeks | 
| Change From Baseline of Tibial Slope Both Study Arms | Determine radiographic analysis by measuring tibial angles in degrees | Baseline, post-operative 6 weeks | 
| Related Complications | Assess adverse events and serious adverse events related to both procedures | Baseline, day of surgery, post-op 6 weeks |