MAKO Total Knee Artroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

Early Outcomes of Total Knee Arthroplasty Using the MAKO Surgical Robot and Triathlon Knee

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05744895
• Other study ID #: 202106145
• Status: Active, not recruiting
• Start date: September 14, 2021
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 95
• Est. completion date: June 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Creve Coeur	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Stryker Nordic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.; [Time Frame: 1 day- post op]	4 weeks
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.	1 year