Trial Outcomes & Findings for MAKO Total Knee Artroplasty (NCT NCT05744895)
NCT ID: NCT05744895
Last Updated: 2026-02-17
Results Overview
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)
Recruitment status
COMPLETED
Target enrollment
123 participants
Primary outcome timeframe
1 week
Results posted on
2026-02-17
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
Control- Manual Total Knee Arthroplasty
Patients who have had a manual total knee arthroplasty
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
114
|
|
Overall Study
COMPLETED
|
95
|
114
|
|
Overall Study
NOT COMPLETED
|
28
|
0
|
Reasons for withdrawal
| Measure |
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
|
Control- Manual Total Knee Arthroplasty
Patients who have had a manual total knee arthroplasty
|
|---|---|---|
|
Overall Study
did not get MAKO
|
6
|
0
|
|
Overall Study
Withdrawal by Subject
|
11
|
0
|
|
Overall Study
Adverse Event
|
7
|
0
|
|
Overall Study
cancelled surgery
|
4
|
0
|
Baseline Characteristics
data was not completed for 1 patient
Baseline characteristics by cohort
| Measure |
Prospective Group- Robotic TKA Arm
n=95 Participants
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
|
Control- Manual Total Knee Arthroplasty
n=114 Participants
Patients who have had a manual total knee arthroplasty
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=94 Participants • data was not completed for 1 patient
|
0 Participants
n=114 Participants • data was not completed for 1 patient
|
0 Participants
n=208 Participants • data was not completed for 1 patient
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=94 Participants • data was not completed for 1 patient
|
74 Participants
n=114 Participants • data was not completed for 1 patient
|
114 Participants
n=208 Participants • data was not completed for 1 patient
|
|
Age, Categorical
>=65 years
|
54 Participants
n=94 Participants • data was not completed for 1 patient
|
40 Participants
n=114 Participants • data was not completed for 1 patient
|
94 Participants
n=208 Participants • data was not completed for 1 patient
|
|
Age, Continuous
|
66 years
n=95 Participants
|
63.2 years
n=114 Participants
|
64.5 years
n=209 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=95 Participants
|
60 Participants
n=114 Participants
|
107 Participants
n=209 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=95 Participants
|
54 Participants
n=114 Participants
|
102 Participants
n=209 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
95 participants
n=95 Participants
|
114 participants
n=114 Participants
|
209 participants
n=209 Participants
|
PRIMARY outcome
Timeframe: 1 weekTo 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)
Outcome measures
| Measure |
Prospective Group- Robotic TKA Arm
n=94 Participants
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
|
Control- Manual Total Knee Arthroplasty
n=114 Participants
Patients who have had a manual total knee arthroplasty
|
|---|---|---|
|
Early Recovery
|
3.6 score on a scale
Interval 0.0 to 10.0
|
4.2 score on a scale
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: 1 yearTo 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.
Outcome measures
Outcome data not reported
Adverse Events
Prospective Group- Robotic TKA Arm
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Control- Manual Total Knee Arthroplasty
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Prospective Group- Robotic TKA Arm
n=95 participants at risk
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
|
Control- Manual Total Knee Arthroplasty
n=114 participants at risk
Patients who have had a manual total knee arthroplasty
|
|---|---|---|
|
Vascular disorders
hospitalized with DVT
|
0.00%
0/95 • adverse event data was collected up to 1 year
|
0.88%
1/114 • Number of events 1 • adverse event data was collected up to 1 year
|
Other adverse events
| Measure |
Prospective Group- Robotic TKA Arm
n=95 participants at risk
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
|
Control- Manual Total Knee Arthroplasty
n=114 participants at risk
Patients who have had a manual total knee arthroplasty
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
hip bursitis
|
1.1%
1/95 • Number of events 1 • adverse event data was collected up to 1 year
|
0.00%
0/114 • adverse event data was collected up to 1 year
|
|
Musculoskeletal and connective tissue disorders
knee stiffness
|
1.1%
1/95 • Number of events 1 • adverse event data was collected up to 1 year
|
0.00%
0/114 • adverse event data was collected up to 1 year
|
|
Musculoskeletal and connective tissue disorders
sciatica
|
1.1%
1/95 • Number of events 1 • adverse event data was collected up to 1 year
|
0.00%
0/114 • adverse event data was collected up to 1 year
|
|
Musculoskeletal and connective tissue disorders
fall
|
1.1%
1/95 • Number of events 1 • adverse event data was collected up to 1 year
|
0.00%
0/114 • adverse event data was collected up to 1 year
|
|
Cardiac disorders
tachycardia
|
1.1%
1/95 • Number of events 1 • adverse event data was collected up to 1 year
|
0.00%
0/114 • adverse event data was collected up to 1 year
|
|
Musculoskeletal and connective tissue disorders
cellulitis
|
1.1%
1/95 • adverse event data was collected up to 1 year
|
0.00%
0/114 • adverse event data was collected up to 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place