Osteo Arthritis Knee, Total Knee Arthroplasty
Conditions
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.
Interventions
DEVICEMyKnee with single use Efficiency Instrument
Total Knee Arthroplasty utilizing a CT scan for customization of cutting blocks with single use instrumentation
DEVICEStryker Navigational with conventional metal instruments
Total Knee Arthroplasty without customization of cutting blocks using conventional metal instruments.
Sponsors
Medacta USA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare Time-saving Associated With the Two Procedures. | Day of surgery | Measure clean up time at end of surgery in minutes |
| Patient OR Time From Both Study Arms | Day of surgery | Measure skin to skin, tourniquet time and femoral and tibial resection time in minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss From Both Study Arms | Day of surgery | Volume of estimated blood loss in cc's |
| Baseline of Hemoglobin Both Study Arms | Baseline, 1 day post-op or at discharge from hospital | Measure in grams per deciliter |
| Volume of Transfusions Both Study Arms | Day of surgery | Measure amount of blood patient receives in ML |
| Instrument Trays Sent to Sterilization Both Study Arms | Day of surgery | Record number of trays sent to be sterilized |
| Amount of Waste From Surgery Both Study Arms | Day of surgery | Combined weight of recyclable and non-recyclable waste in grams |
| Baseline of Mechanical Axis Both Study Arms | Baseline, post-operative 6 weeks | Determine radiographic analysis by measuring knee mechanical axis in degrees |
| Change From Baseline of Tibial Slope Both Study Arms | Baseline, post-operative 6 weeks | Determine radiographic analysis by measuring tibial angles in degrees |
| Related Complications | Baseline, day of surgery, post-op 6 weeks | Assess adverse events and serious adverse events related to both procedures |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MyKnee With Single Use Efficiency Instrument 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.
MyKnee with single use Efficiency Instrument: Total Knee Arthroplasty utilizing a CT scan for customization of cutting blocks with single use instrumentation | 46 |
| Stryker Navigational With Conventional Metal Instruments Patients randomized in this group will undergo Total Knee Arthroplasty with conventional metal instruments. CT scan are not utilized with this arm.
Stryker Navigational with conventional metal instruments: Total Knee Arthroplasty without customization of cutting blocks using conventional metal instruments. | 36 |
| Total | 82 |
Baseline characteristics
| Characteristic | Stryker Navigational With Conventional Metal Instruments | Total | MyKnee With Single Use Efficiency Instrument |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 41 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 41 Participants | 25 Participants |
| Age, Continuous | 65.67 years | 64.99 years | 64.32 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 36 participants | 82 participants | 46 participants |
| Sex: Female, Male Female | 28 Participants | 58 Participants | 30 Participants |
| Sex: Female, Male Male | 8 Participants | 24 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 36 |
| other Total, other adverse events | 3 / 46 | 1 / 36 |
| serious Total, serious adverse events | 0 / 46 | 0 / 36 |
Outcome results
Primary
Compare Time-saving Associated With the Two Procedures.
Measure clean up time at end of surgery in minutes
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MyKnee With Single Use Efficiency Instrument | Compare Time-saving Associated With the Two Procedures. | 25.12 minutes |
| Stryker Navigational With Conventional Metal Instruments | Compare Time-saving Associated With the Two Procedures. | 28.47 minutes |
Primary
Patient OR Time From Both Study Arms
Measure skin to skin, tourniquet time and femoral and tibial resection time in minutes
Time frame: Day of surgery
Population: Number analyzed differs due to uncollected data
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MyKnee With Single Use Efficiency Instrument | Patient OR Time From Both Study Arms | incision to closure time | 69.83 minutes |
| MyKnee With Single Use Efficiency Instrument | Patient OR Time From Both Study Arms | tourniquet time | 53.07 minutes |
| MyKnee With Single Use Efficiency Instrument | Patient OR Time From Both Study Arms | femur and tibia time | 10.98 minutes |
| Stryker Navigational With Conventional Metal Instruments | Patient OR Time From Both Study Arms | incision to closure time | 70.44 minutes |
| Stryker Navigational With Conventional Metal Instruments | Patient OR Time From Both Study Arms | tourniquet time | 52.84 minutes |
| Stryker Navigational With Conventional Metal Instruments | Patient OR Time From Both Study Arms | femur and tibia time | 11.87 minutes |
Secondary
Amount of Waste From Surgery Both Study Arms
Combined weight of recyclable and non-recyclable waste in grams
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MyKnee With Single Use Efficiency Instrument | Amount of Waste From Surgery Both Study Arms | 20196.7 grams |
| Stryker Navigational With Conventional Metal Instruments | Amount of Waste From Surgery Both Study Arms | 17653.5 grams |
Secondary
Baseline of Hemoglobin Both Study Arms
Measure in grams per deciliter
Time frame: Baseline, 1 day post-op or at discharge from hospital
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MyKnee With Single Use Efficiency Instrument | Baseline of Hemoglobin Both Study Arms | Baseline | 14.18 grams per deciliter |
| MyKnee With Single Use Efficiency Instrument | Baseline of Hemoglobin Both Study Arms | Post-op | 12.57 grams per deciliter |
| Stryker Navigational With Conventional Metal Instruments | Baseline of Hemoglobin Both Study Arms | Baseline | 13.77 grams per deciliter |
| Stryker Navigational With Conventional Metal Instruments | Baseline of Hemoglobin Both Study Arms | Post-op | 12.31 grams per deciliter |
Secondary
Baseline of Mechanical Axis Both Study Arms
Determine radiographic analysis by measuring knee mechanical axis in degrees
Time frame: Baseline, post-operative 6 weeks
Population: Data only available for 44 of 46 participants in Myknee arm
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MyKnee With Single Use Efficiency Instrument | Baseline of Mechanical Axis Both Study Arms | Baseline | 6.05 degrees |
| MyKnee With Single Use Efficiency Instrument | Baseline of Mechanical Axis Both Study Arms | Post-operative 6 weeks | 1.64 degrees |
| Stryker Navigational With Conventional Metal Instruments | Baseline of Mechanical Axis Both Study Arms | Baseline | 5.71 degrees |
| Stryker Navigational With Conventional Metal Instruments | Baseline of Mechanical Axis Both Study Arms | Post-operative 6 weeks | 1.24 degrees |
Secondary
Change From Baseline of Tibial Slope Both Study Arms
Determine radiographic analysis by measuring tibial angles in degrees
Time frame: Baseline, post-operative 6 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MyKnee With Single Use Efficiency Instrument | Change From Baseline of Tibial Slope Both Study Arms | Baseline | 3.80 degrees |
| MyKnee With Single Use Efficiency Instrument | Change From Baseline of Tibial Slope Both Study Arms | Post-operative 6 weeks | 1.8 degrees |
| Stryker Navigational With Conventional Metal Instruments | Change From Baseline of Tibial Slope Both Study Arms | Baseline | 2.08 degrees |
| Stryker Navigational With Conventional Metal Instruments | Change From Baseline of Tibial Slope Both Study Arms | Post-operative 6 weeks | 1.87 degrees |
Secondary
Estimated Blood Loss From Both Study Arms
Volume of estimated blood loss in cc's
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MyKnee With Single Use Efficiency Instrument | Estimated Blood Loss From Both Study Arms | 105.43 cc's |
| Stryker Navigational With Conventional Metal Instruments | Estimated Blood Loss From Both Study Arms | 100 cc's |
Secondary
Instrument Trays Sent to Sterilization Both Study Arms
Record number of trays sent to be sterilized
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MyKnee With Single Use Efficiency Instrument | Instrument Trays Sent to Sterilization Both Study Arms | 5.48 trays |
| Stryker Navigational With Conventional Metal Instruments | Instrument Trays Sent to Sterilization Both Study Arms | 9.5 trays |
Secondary
Related Complications
Assess adverse events and serious adverse events related to both procedures
Time frame: Baseline, day of surgery, post-op 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MyKnee With Single Use Efficiency Instrument | Related Complications | 0 Participants |
| Stryker Navigational With Conventional Metal Instruments | Related Complications | 0 Participants |
Secondary
Volume of Transfusions Both Study Arms
Measure amount of blood patient receives in ML
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MyKnee With Single Use Efficiency Instrument | Volume of Transfusions Both Study Arms | 0 mL |
| Stryker Navigational With Conventional Metal Instruments | Volume of Transfusions Both Study Arms | 0 mL |