Clinical trial NCT05744895: MAKO Total Knee Artroplasty
Official title: Early Outcomes of Total Knee Arthroplasty Using the MAKO Surgical Robot and Triathlon Knee
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis, Knee
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Stryker Nordic
First posted: 2023-02-27
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We propose to enroll patients that are scheduled for a MAKO Total knee arthroplasty

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.

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

Primary outcomes:
measure: Early recovery
timeFrame: 4 weeks
Secondary outcomes:
measure: Post op EOS measurements for alignment
timeFrame: 1 year
Other outcomes:
Locations:
city: Creve Coeur
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Charles Hannon, MD
role: PRINCIPAL_INVESTIGATOR
References: