Osteoarthritis, Knee
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDevice: Robotic MAKO total knee
Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine
DEVICEFocusMotion knee brace
Focusmotion knee brace measures range of motion during exercises
DEVICEFitbit tracking device
Fitbit will measure patients steps, HR, and sleep
DEVICEFocusMotion app
Will survey patients with PROMS
Sponsors
Washington University School of Medicine
Stryker Nordic
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planning to undergo Unilateral primary total knee arthroplasty * 18 and up * Willing to sign informed consent * Willing to return for all follow-up visits * Smartphone or tablet device capable of running the Fitbit andFocusMotion platform
Exclusion criteria
* BMI \> 45 * Inflammatory arthritis * Narcotic use greater than 5 days per week * Walking aid for musculoskeletal or neurologic issue other than operative joint * Bilateral total knee arthroplasty * Patient with an active infection or suspected infection in the operative joint * The absolute and relative contraindications stated in the FDA cleared labeling for the device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Recovery | 1 week | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post op EOS Measurements for Alignment | 1 year | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCharles Hannon, MD
Washington University School of Medicine
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 40 Participants |
| Age, Categorical Between 18 and 65 years | 114 Participants |
| Age, Continuous | 63.2 years |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 209 participants |
| Sex: Female, Male Female | 107 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 95 | 1 / 114 |
| other Total, other adverse events | 6 / 95 | 0 / 114 |
| serious Total, serious adverse events | 0 / 95 | 1 / 114 |
Outcome results
None listed