Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty performed using two different specific surgical techniques.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyKnee with single use Efficiency Instrument | Active Comparator | 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. |
|
| Stryker Navigational with conventional metal instruments | Active Comparator | Patients randomized in this group will undergo Total Knee Arthroplasty with conventional metal instruments. CT scan are not utilized with this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyKnee with single use Efficiency Instrument | Device | Total Knee Arthroplasty utilizing a CT scan for customization of cutting blocks with single use instrumentation |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Hur, MD | Forte Sports Medicine and Orthopedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Sports Medicine Research & Education Foundation | Indianapolis | Indiana | 46280 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Compare Time-saving Associated With the Two Procedures. | Measure clean up time at end of surgery in minutes | Posted | Mean | Full Range | minutes | Day of surgery |
|
6 weeks post-op
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute posterior knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rena Mandino, Director, Clinical Research | Medacta USA | 352-359-3581 | rmandino@medacta.us.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2017 | Mar 17, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Stryker Navigational with conventional metal instruments | Device | Total Knee Arthroplasty without customization of cutting blocks using conventional metal instruments. |
|
| 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Patient OR Time From Both Study Arms | Measure skin to skin, tourniquet time and femoral and tibial resection time in minutes | Number analyzed differs due to uncollected data | Posted | Mean | Full Range | minutes | Day of surgery |
|
|
|
| Secondary | Estimated Blood Loss From Both Study Arms | Volume of estimated blood loss in cc's | Posted | Mean | Full Range | cc's | Day of surgery |
|
|
|
| Secondary | Baseline of Hemoglobin Both Study Arms | Measure in grams per deciliter | Posted | Mean | Full Range | grams per deciliter | Baseline, 1 day post-op or at discharge from hospital |
|
|
|
| Secondary | Volume of Transfusions Both Study Arms | Measure amount of blood patient receives in ML | Posted | Mean | Full Range | mL | Day of surgery |
|
|
|
| Secondary | Instrument Trays Sent to Sterilization Both Study Arms | Record number of trays sent to be sterilized | Posted | Mean | Full Range | trays | Day of surgery |
|
|
|
| Secondary | Amount of Waste From Surgery Both Study Arms | Combined weight of recyclable and non-recyclable waste in grams | Posted | Mean | Full Range | grams | Day of surgery |
|
|
|
| Secondary | Baseline of Mechanical Axis Both Study Arms | Determine radiographic analysis by measuring knee mechanical axis in degrees | Data only available for 44 of 46 participants in Myknee arm | Posted | Mean | Full Range | degrees | Baseline, post-operative 6 weeks |
|
|
|
| Secondary | Change From Baseline of Tibial Slope Both Study Arms | Determine radiographic analysis by measuring tibial angles in degrees | Posted | Mean | Full Range | degrees | Baseline, post-operative 6 weeks |
|
|
|
| Secondary | Related Complications | Assess adverse events and serious adverse events related to both procedures | Posted | Count of Participants | Participants | Baseline, day of surgery, post-op 6 weeks |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 3 |
| 46 |
| EG001 | 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. | 0 | 36 | 0 | 36 | 1 | 36 |
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
|
| Weepy Left Knee Incision | Surgical and medical procedures | Systematic Assessment |
|
| Extremely stiff with swelling and pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
| tourniquet time |
|
|
| femur and tibia time |
|
|