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

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Customized patient instruments
* Device: Traditional Metal Instruments


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Customized patient instruments<br>Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks) | Device: Customized patient instruments<br>* Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.<br>* Other names: Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®);|
| Active Comparator: Traditional metal instruments<br>Control Group: Patients will undergo conventional surgical technique | Device: Traditional Metal Instruments<br>* Traditional metal instrument will be used to make bone cuts and size the components in this control group.<br>* Other names: Traditional Metal Instruments with Conventional Surgical Technique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OR Total Time | Total time patient is in operating room | Day of Surgery | 
| Opening Instruments | Time to open surgical instruments | Day of Surgery | 
| Back Table Setup Time | Time to set up back surgical table | Day of Surgery | 
| Tourniquet Time | Time tourniquet is on patient during surgery | Day of Surgery | 
| Incision to Skin Closure | Time from incision to skin closure during surgery | Day of Surgery | 
| Bone Prep Time | Time to prepare bone for implant during surgery | Day of Surgery | 
| Patella Resection Time | Time to resection patella during surgery | Day of Surgery | 
| Clean-up Time | Time to clean up following surgery | Day of Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Range | Post op 1 day hemoglobin range | 24 hours or at discharge if patient does not stay overnight | 
| Surgical Waste Weight | Weigh surgical waste at the end of each surgery | Day of Surgery | 
| Mechanical Axis | Radiographic analysis of mechanical axis alignment | Pre-Operative | 
| Mechanical Axis | Radiographic analysis of mechanical axis alignment | Post-Operative | 
| Tibial Slope | Radiographic analysis of Tibial Posterior Slope | Pre-Operative | 
| Tibial Slope | Radiographic analysis of Tibial Posterior Slope | Post-Operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Replacement