Trial Outcomes & Findings for Comparing Surgical and Economical Parameters of Total Knee Replacement. (NCT NCT03427047)
NCT ID: NCT03427047
Last Updated: 2023-06-13
Results Overview
Measure clean up time at end of surgery in minutes
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
Day of surgery
Results posted on
2023-06-13
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
36
|
|
Overall Study
COMPLETED
|
46
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MyKnee With Single Use Efficiency Instrument
n=46 Participants
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
|
Stryker Navigational With Conventional Metal Instruments
n=36 Participants
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.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=46 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=82 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=46 Participants
|
16 Participants
n=36 Participants
|
41 Participants
n=82 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=46 Participants
|
20 Participants
n=36 Participants
|
41 Participants
n=82 Participants
|
|
Age, Continuous
|
64.32 years
n=46 Participants
|
65.67 years
n=36 Participants
|
64.99 years
n=82 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=46 Participants
|
28 Participants
n=36 Participants
|
58 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=46 Participants
|
8 Participants
n=36 Participants
|
24 Participants
n=82 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
46 participants
n=46 Participants
|
36 participants
n=36 Participants
|
82 participants
n=82 Participants
|
PRIMARY outcome
Timeframe: Day of surgeryMeasure clean up time at end of surgery in minutes
Outcome measures
| Measure |
MyKnee With Single Use Efficiency Instrument
n=46 Participants
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
|
Stryker Navigational With Conventional Metal Instruments
n=36 Participants
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.
|
|---|---|---|
|
Compare Time-saving Associated With the Two Procedures.
|
25.12 minutes
Interval 8.0 to 52.33
|
28.47 minutes
Interval 10.0 to 130.1
|
PRIMARY outcome
Timeframe: Day of surgeryPopulation: Number analyzed differs due to uncollected data
Measure skin to skin, tourniquet time and femoral and tibial resection time in minutes
Outcome measures
| Measure |
MyKnee With Single Use Efficiency Instrument
n=46 Participants
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
|
Stryker Navigational With Conventional Metal Instruments
n=36 Participants
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.
|
|---|---|---|
|
Patient OR Time From Both Study Arms
incision to closure time
|
69.83 minutes
Interval 51.47 to 97.32
|
70.44 minutes
Interval 58.42 to 82.82
|
|
Patient OR Time From Both Study Arms
tourniquet time
|
53.07 minutes
Interval 41.98 to 78.48
|
52.84 minutes
Interval 27.25 to 92.03
|
|
Patient OR Time From Both Study Arms
femur and tibia time
|
10.98 minutes
Interval 4.68 to 30.08
|
11.87 minutes
Interval 0.83 to 19.8
|
SECONDARY outcome
Timeframe: Day of surgeryVolume of estimated blood loss in cc's
Outcome measures
| Measure |
MyKnee With Single Use Efficiency Instrument
n=46 Participants
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
|
Stryker Navigational With Conventional Metal Instruments
n=36 Participants
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.
|
|---|---|---|
|
Estimated Blood Loss From Both Study Arms
|
105.43 cc's
Interval 50.0 to 200.0
|
100 cc's
Interval 50.0 to 200.0
|
SECONDARY outcome
Timeframe: Baseline, 1 day post-op or at discharge from hospitalMeasure in grams per deciliter
Outcome measures
| Measure |
MyKnee With Single Use Efficiency Instrument
n=46 Participants
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
|
Stryker Navigational With Conventional Metal Instruments
n=36 Participants
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.
|
|---|---|---|
|
Baseline of Hemoglobin Both Study Arms
Baseline
|
14.18 grams per deciliter
Interval 12.2 to 16.3
|
13.77 grams per deciliter
Interval 11.4 to 15.7
|
|
Baseline of Hemoglobin Both Study Arms
Post-op
|
12.57 grams per deciliter
Interval 10.7 to 15.2
|
12.31 grams per deciliter
Interval 9.6 to 15.6
|
SECONDARY outcome
Timeframe: Day of surgeryMeasure amount of blood patient receives in ML
Outcome measures
| Measure |
MyKnee With Single Use Efficiency Instrument
n=46 Participants
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
|
Stryker Navigational With Conventional Metal Instruments
n=36 Participants
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.
|
|---|---|---|
|
Volume of Transfusions Both Study Arms
|
0 mL
Interval 0.0 to 0.0
|
0 mL
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day of surgeryRecord number of trays sent to be sterilized
Outcome measures
| Measure |
MyKnee With Single Use Efficiency Instrument
n=46 Participants
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
|
Stryker Navigational With Conventional Metal Instruments
n=36 Participants
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.
|
|---|---|---|
|
Instrument Trays Sent to Sterilization Both Study Arms
|
5.48 trays
Interval 3.0 to 7.0
|
9.5 trays
Interval 7.0 to 20.0
|
SECONDARY outcome
Timeframe: Day of surgeryCombined weight of recyclable and non-recyclable waste in grams
Outcome measures
| Measure |
MyKnee With Single Use Efficiency Instrument
n=46 Participants
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
|
Stryker Navigational With Conventional Metal Instruments
n=36 Participants
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.
|
|---|---|---|
|
Amount of Waste From Surgery Both Study Arms
|
20196.7 grams
Interval 14242.8 to 27442.3
|
17653.5 grams
Interval 13108.8 to 20910.6
|
SECONDARY outcome
Timeframe: Baseline, post-operative 6 weeksPopulation: Data only available for 44 of 46 participants in Myknee arm
Determine radiographic analysis by measuring knee mechanical axis in degrees
Outcome measures
| Measure |
MyKnee With Single Use Efficiency Instrument
n=44 Participants
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
|
Stryker Navigational With Conventional Metal Instruments
n=34 Participants
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.
|
|---|---|---|
|
Baseline of Mechanical Axis Both Study Arms
Baseline
|
6.05 degrees
Interval 0.0 to 12.0
|
5.71 degrees
Interval 0.0 to 15.0
|
|
Baseline of Mechanical Axis Both Study Arms
Post-operative 6 weeks
|
1.64 degrees
Interval 0.0 to 6.0
|
1.24 degrees
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: Baseline, post-operative 6 weeksDetermine radiographic analysis by measuring tibial angles in degrees
Outcome measures
| Measure |
MyKnee With Single Use Efficiency Instrument
n=44 Participants
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
|
Stryker Navigational With Conventional Metal Instruments
n=34 Participants
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.
|
|---|---|---|
|
Change From Baseline of Tibial Slope Both Study Arms
Baseline
|
3.80 degrees
Interval 0.0 to 12.0
|
2.08 degrees
Interval 0.0 to 8.0
|
|
Change From Baseline of Tibial Slope Both Study Arms
Post-operative 6 weeks
|
1.8 degrees
Interval 0.0 to 8.0
|
1.87 degrees
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline, day of surgery, post-op 6 weeksAssess adverse events and serious adverse events related to both procedures
Outcome measures
| Measure |
MyKnee With Single Use Efficiency Instrument
n=46 Participants
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
|
Stryker Navigational With Conventional Metal Instruments
n=34 Participants
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.
|
|---|---|---|
|
Related Complications
|
0 Participants
|
0 Participants
|
Adverse Events
MyKnee With Single Use Efficiency Instrument
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stryker Navigational With Conventional Metal Instruments
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MyKnee With Single Use Efficiency Instrument
n=46 participants at risk
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
|
Stryker Navigational With Conventional Metal Instruments
n=36 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Acute posterior knee pain
|
2.2%
1/46 • Number of events 1 • 6 weeks post-op
|
0.00%
0/36 • 6 weeks post-op
|
|
Vascular disorders
Deep Vein Thrombosis
|
2.2%
1/46 • Number of events 1 • 6 weeks post-op
|
0.00%
0/36 • 6 weeks post-op
|
|
Surgical and medical procedures
Weepy Left Knee Incision
|
0.00%
0/46 • 6 weeks post-op
|
2.8%
1/36 • Number of events 1 • 6 weeks post-op
|
|
Musculoskeletal and connective tissue disorders
Extremely stiff with swelling and pain
|
2.2%
1/46 • Number of events 1 • 6 weeks post-op
|
0.00%
0/36 • 6 weeks post-op
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60