Early Outcomes of Total Knee Arthroplasty Using the MAKO Surgical Robot and Triathlon Knee
Overview
- Phase
- Not Applicable
- Intervention
- Device: Robotic MAKO total knee
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Washington University School of Medicine
- Enrollment
- 123
- Locations
- 1
- Primary Endpoint
- Early Recovery
- Status
- Completed
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Prospective Group- Robotic TKA Arm
Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine
Intervention: Device: Robotic MAKO total knee
Prospective Group- Robotic TKA Arm
Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine
Intervention: FocusMotion knee brace
Prospective Group- Robotic TKA Arm
Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine
Intervention: Fitbit tracking device
Prospective Group- Robotic TKA Arm
Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine
Intervention: FocusMotion app
Control- manual total Knee arthroplasty
Patients who have had a manual total knee arthroplasty
Outcomes
Primary Outcomes
Early Recovery
Time Frame: 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 Outcomes
- Post op EOS Measurements for Alignment(1 year)