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| Name | Class |
|---|---|
| Stryker Nordic | INDUSTRY |
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The purpose of this study is to determine the early clinical and radiographic outcomes of robotically assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon knee system. Results of this study will be compared to those of a previously published cohort of patients from this institution who underwent TKA using non-robotic, manual instruments.
MAKO TKA patients will be given Fitbits and the Focus Motion Knee Brace to capture the data listed in attachment section. The results of this data will be compared to the control group to see if there is or there is not a difference in clinical outcomes with patients receiving Total knee surgery using the MAKO surgical robot versus those who got Total knee surgery without the MAKO robot.
Research objectives:
The purpose of this study is to determine the early clinical and radiographic outcomes of robotically assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon knee system. Mean weekly VAS pain score during the first 4 weeks is the primary end point. Results of this study will be compared to prospective cohort of patients in the IRB study 201805014 from this institution who underwent TKA using non-robotic, manual instruments
Primary Hypothesis: Patients receiving robotic TKA will have better early recovery, including lower mean weekly VAS pain score for the first 4 weeks postoperatively and higher functional outcome scores, than the manual TKA historical cohort.
Secondary Hypothesis:
Patients receiving robotic TKA will have more accurate component position and alignment than the manual TKA historical cohort.
Potential Contribution: This study would give us a better understanding of the clinical and radiographic outcomes of patients receiving robotic TKA versus manual TKA. It will identify potential advantages and disadvantages of robotic TKA using the MAKO surgical robot.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Group- Robotic TKA Arm | Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine |
| |
| Control- manual total Knee arthroplasty | Patients who have had a manual total knee arthroplasty |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: Robotic MAKO total knee | Device | Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early Recovery | To determine if Robotic-arm assisted TKA (RA-TKA) allows for earlier recovery than manual TKA (MI-TKA). This will be measured by weekly VAS pain score. VAS scale 0-10 (0= no pain, 10=extreme pain) | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Post op EOS Measurements for Alignment | To determine if Robotic-arm assisted TKA (RA-TKA) allows for more accurate component placement than manual TKA (MI-TKA). units of measurement will be inches. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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We propose to enroll patients that are scheduled for a MAKO Total knee arthroplasty
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| Name | Affiliation | Role |
|---|---|---|
| Charles Hannon, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | Creve Coeur | Missouri | 63141 | United States |
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123 patients had completed consent. Not until after consent these 28 patients were not continued due to various reasons. These patients were scheduled for surgery.
enrollment number is correct. all these patients started study procedures (answering surveys and doing exercises, wearing fitbit) patients were either discontinued either right before surgery or after surgery.
control group is from another study NCT04923724.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prospective Group- Robotic TKA Arm | Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine Device: Robotic MAKO total knee: Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine FocusMotion knee brace: Focusmotion knee brace measures range of motion during exercises Fitbit tracking device: Fitbit will measure patients steps, HR, and sleep FocusMotion app: Will survey patients with PROMS |
| FG001 | Control- Manual Total Knee Arthroplasty | Patients who have had a manual total knee arthroplasty |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prospective Group- Robotic TKA Arm | Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine Device: Robotic MAKO total knee: Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine FocusMotion knee brace: Focusmotion knee brace measures range of motion during exercises Fitbit tracking device: Fitbit will measure patients steps, HR, and sleep FocusMotion app: Will survey patients with PROMS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | data was not completed for 1 patient |
| 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 | Early Recovery | To determine if Robotic-arm assisted TKA (RA-TKA) allows for earlier recovery than manual TKA (MI-TKA). This will be measured by weekly VAS pain score. VAS scale 0-10 (0= no pain, 10=extreme pain) | Posted | Mean | Full Range | score on a scale | 1 week |
|
adverse event data was collected up to 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prospective Group- Robotic TKA Arm | Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine Device: Robotic MAKO total knee: Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine FocusMotion knee brace: Focusmotion knee brace measures range of motion during exercises Fitbit tracking device: Fitbit will measure patients steps, HR, and sleep FocusMotion app: Will survey patients with PROMS |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalized with DVT | Vascular disorders | Non-systematic Assessment | patient was hospitalized with DVT with moderate severity was determined not related to device and patient recovered. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hip bursitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Venessa Riegler | Washington University | 314-362-1721 | rieglerv@wustl.edu |
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| 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 | Dec 3, 2021 | Jan 7, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| FocusMotion knee brace | Device | Focusmotion knee brace measures range of motion during exercises |
|
| Fitbit tracking device | Device | Fitbit will measure patients steps, HR, and sleep |
|
| FocusMotion app | Device | Will survey patients with PROMS |
|
| Adverse Event |
|
| cancelled surgery |
|
| BG001 | Control- Manual Total Knee Arthroplasty | Patients who have had a manual total knee arthroplasty |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| 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 |
|
Patients who have had a manual total knee arthroplasty |
|
|
| Secondary | Post op EOS Measurements for Alignment | To determine if Robotic-arm assisted TKA (RA-TKA) allows for more accurate component placement than manual TKA (MI-TKA). units of measurement will be inches. | Not Posted | 1 year | Participants |
| 0 |
| 95 |
| 0 |
| 95 |
| 6 |
| 95 |
| EG001 | Control- Manual Total Knee Arthroplasty | Patients who have had a manual total knee arthroplasty | 1 | 114 | 1 | 114 | 0 | 114 |
|
| knee stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| sciatica | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| cellulitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |