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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
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.
Traditional metal instrument will be used to make bone cuts and size the components in this control group.
Tandem Clinical Research, LLC
Marrero, Louisiana, United States
Ortho Montana
Billings, Montana, United States
Orthopedic Associates Meadville
Meadville, Pennsylvania, United States
Texas Orthopedics
Austin, Texas, United States
OR Total Time
Total time patient is in operating room
Time frame: Day of Surgery
Opening Instruments
Time to open surgical instruments
Time frame: Day of Surgery
Back Table Setup Time
Time to set up back surgical table
Time frame: Day of Surgery
Tourniquet Time
Time tourniquet is on patient during surgery
Time frame: Day of Surgery
Incision to Skin Closure
Time from incision to skin closure during surgery
Time frame: Day of Surgery
Bone Prep Time
Time to prepare bone for implant during surgery
Time frame: Day of Surgery
Patella Resection Time
Time to resection patella during surgery
Time frame: Day of Surgery
Clean-up Time
Time to clean up following surgery
Time frame: Day of Surgery
Hemoglobin Range
Post op 1 day hemoglobin range
Time frame: 24 hours or at discharge if patient does not stay overnight
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Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence
West Jordan, Utah, United States
Surgical Waste Weight
Weigh surgical waste at the end of each surgery
Time frame: Day of Surgery
Mechanical Axis
Radiographic analysis of mechanical axis alignment
Time frame: Pre-Operative
Mechanical Axis
Radiographic analysis of mechanical axis alignment
Time frame: Post-Operative
Tibial Slope
Radiographic analysis of Tibial Posterior Slope
Time frame: Pre-Operative
Tibial Slope
Radiographic analysis of Tibial Posterior Slope
Time frame: Post-Operative