Trial Outcomes & Findings for A Randomized, Study to Evaluate the Iovera° Device in Treating Pain Associated With Total Knee Arthroplasty (NCT NCT02284113)
NCT ID: NCT02284113
Last Updated: 2024-01-24
Results Overview
The cumulative morphine equivalent was divided by the number of days to provide a Total Daily Morphine Equivalent (TME) for each Subject.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
hospital discharge to 6 Weeks post-TKA surgery
Results posted on
2024-01-24
Participant Flow
Participant milestones
| Measure |
Treatment
Treatment with focused cold therapy.
iovera°: Use of iovera° device to administer treatment Focused Cold Therapy
|
Sham
Sham treatment with focused cold therapy device
iovera° Sham: iovera° device used for sham treatment
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
76
|
|
Overall Study
COMPLETED
|
71
|
73
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Treatment
Treatment with focused cold therapy.
iovera°: Use of iovera° device to administer treatment Focused Cold Therapy
|
Sham
Sham treatment with focused cold therapy device
iovera° Sham: iovera° device used for sham treatment
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
non-compliance
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
not provided
|
0
|
1
|
|
Overall Study
surgery cancelled
|
2
|
0
|
Baseline Characteristics
A Randomized, Study to Evaluate the Iovera° Device in Treating Pain Associated With Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Treatment
n=74 Participants
Treatment with focused cold therapy.
iovera°: Use of iovera° device to administer treatment Focused Cold Therapy
|
Sham
n=76 Participants
Sham treatment with focused cold therapy device
iovera° Sham: iovera° device used for sham treatment
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 7.53 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 9.33 • n=7 Participants
|
65.3 years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=5 Participants
|
76 participants
n=7 Participants
|
150 participants
n=5 Participants
|
|
BMI
|
31.0 kg/m^2
STANDARD_DEVIATION 4.61 • n=5 Participants
|
30.6 kg/m^2
STANDARD_DEVIATION 4.79 • n=7 Participants
|
30.79 kg/m^2
STANDARD_DEVIATION 4.69 • n=5 Participants
|
PRIMARY outcome
Timeframe: hospital discharge to 6 Weeks post-TKA surgeryThe cumulative morphine equivalent was divided by the number of days to provide a Total Daily Morphine Equivalent (TME) for each Subject.
Outcome measures
| Measure |
Treatment
n=69 Participants
Treatment with focused cold therapy.
iovera°: Use of iovera° device to administer treatment Focused Cold Therapy
|
Sham
n=71 Participants
Sham treatment with focused cold therapy device
iovera° Sham: iovera° device used for sham treatment
|
|---|---|---|
|
Cumulative Consumption of Opioids Total Daily Morphine Equivalent (TME) (mg/Day)
|
23.9 mg/day
Standard Deviation 15.25
|
27.1 mg/day
Standard Deviation 20.87
|
SECONDARY outcome
Timeframe: Baseline to 6 WeeksThe Numeric Rating Scale for Pain (NRS for Pain) is a measure of pain intensity which is assessed on a scale from 0 to 10 with 0 being no pain at all and 10 being the worst pain imaginable. The Subject provides a self-reported score based on their pain in the target knee at the time the questionnaire is administered (labeled 'now' in the tables below) as well as their pain in the past 7 days (labeled "past 7" in the tables below).
Outcome measures
| Measure |
Treatment
n=73 Participants
Treatment with focused cold therapy.
iovera°: Use of iovera° device to administer treatment Focused Cold Therapy
|
Sham
n=75 Participants
Sham treatment with focused cold therapy device
iovera° Sham: iovera° device used for sham treatment
|
|---|---|---|
|
Change in Pain From Baseline to Six Weeks
"Now"
|
-2.7 score on a scale
Standard Deviation 2.96
|
-3.6 score on a scale
Standard Deviation 3.03
|
|
Change in Pain From Baseline to Six Weeks
"Past 7 days"
|
-2.4 score on a scale
Standard Deviation 3.01
|
-2.9 score on a scale
Standard Deviation 3.28
|
SECONDARY outcome
Timeframe: Baseline to 6 weeks after surgeryThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a tri-dimensional, disease-specific, Subject-reported outcome measure. It consists of 24 questions with 5 questions regarding pain, 2 questions regarding stiffness and 17 questions regarding function in Subjects with osteoarthritis of the hip and/or knee. Each question is answered on a scale of 0 (none)-10 (extreme). Higher scores are associated with worse outcomes.
Outcome measures
| Measure |
Treatment
n=73 Participants
Treatment with focused cold therapy.
iovera°: Use of iovera° device to administer treatment Focused Cold Therapy
|
Sham
n=75 Participants
Sham treatment with focused cold therapy device
iovera° Sham: iovera° device used for sham treatment
|
|---|---|---|
|
Change in WOMAC Scores at 6 Weeks After Surgery
Pain
|
-13.1 score on a scale
Standard Deviation 12.60
|
-14.6 score on a scale
Standard Deviation 13.18
|
|
Change in WOMAC Scores at 6 Weeks After Surgery
Stiffness
|
-4.7 score on a scale
Standard Deviation 5.29
|
-5.5 score on a scale
Standard Deviation 6.78
|
|
Change in WOMAC Scores at 6 Weeks After Surgery
Physical Function
|
-49.4 score on a scale
Standard Deviation 41.66
|
-51.4 score on a scale
Standard Deviation 44.56
|
SECONDARY outcome
Timeframe: treatment to hospital dischargeOutcome measures
| Measure |
Treatment
n=71 Participants
Treatment with focused cold therapy.
iovera°: Use of iovera° device to administer treatment Focused Cold Therapy
|
Sham
n=73 Participants
Sham treatment with focused cold therapy device
iovera° Sham: iovera° device used for sham treatment
|
|---|---|---|
|
Length of Hospital Stay
|
54.7 Hours
Standard Deviation 27.34
|
52.6 Hours
Standard Deviation 24.42
|
SECONDARY outcome
Timeframe: baseline to 2 weeks after surgeryRange of motion measures the physical function of the replaced knee during active flexion at the specified timepoints.
Outcome measures
| Measure |
Treatment
n=73 Participants
Treatment with focused cold therapy.
iovera°: Use of iovera° device to administer treatment Focused Cold Therapy
|
Sham
n=73 Participants
Sham treatment with focused cold therapy device
iovera° Sham: iovera° device used for sham treatment
|
|---|---|---|
|
Change in Active Range of Motion From Baseline to 2 Weeks After Surgery
|
-10.1 Degrees
Standard Deviation 19.51
|
-11.8 Degrees
Standard Deviation 15.56
|
SECONDARY outcome
Timeframe: Baseline, 2,4,6,12 weeksPopulation: The variation in number analyzed is due to the actual number of participants with data collected at specific timepoint
The 40 Meter Walk Test measured the average speed in meters per second a Subject could walk 40 meters.
Outcome measures
| Measure |
Treatment
n=74 Participants
Treatment with focused cold therapy.
iovera°: Use of iovera° device to administer treatment Focused Cold Therapy
|
Sham
n=76 Participants
Sham treatment with focused cold therapy device
iovera° Sham: iovera° device used for sham treatment
|
|---|---|---|
|
40 Meter Walk Test
Baseline
|
1 meters per second
Standard Deviation 0.41
|
1 meters per second
Standard Deviation 0.42
|
|
40 Meter Walk Test
2 weeks
|
0.8 meters per second
Standard Deviation .34
|
0.8 meters per second
Standard Deviation .31
|
|
40 Meter Walk Test
4 weeks
|
0.9 meters per second
Standard Deviation 0.31
|
0.9 meters per second
Standard Deviation 0.34
|
|
40 Meter Walk Test
6 weeks
|
1.0 meters per second
Standard Deviation 0.34
|
1.0 meters per second
Standard Deviation 0.38
|
|
40 Meter Walk Test
12 weeks
|
1.1 meters per second
Standard Deviation 0.35
|
1.1 meters per second
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Baseline, 2,4,6,12 weeks after surgeryPopulation: The variation in number analyzed is due to the actual number of participants with data collected at specific timepoint
The 30 Second Chair Test evaluates physical function during recovery by measuring the number of times a subject could go from seated in a chair to standing over the course of 30 seconds.
Outcome measures
| Measure |
Treatment
n=74 Participants
Treatment with focused cold therapy.
iovera°: Use of iovera° device to administer treatment Focused Cold Therapy
|
Sham
n=76 Participants
Sham treatment with focused cold therapy device
iovera° Sham: iovera° device used for sham treatment
|
|---|---|---|
|
30 Second Chair Test
Baseline
|
8.2 number of repetitions
Standard Deviation 3.38
|
8.6 number of repetitions
Standard Deviation 4.34
|
|
30 Second Chair Test
2 weeks
|
6.9 number of repetitions
Standard Deviation 3.26
|
7.5 number of repetitions
Standard Deviation 3.07
|
|
30 Second Chair Test
4 weeks
|
9.6 number of repetitions
Standard Deviation 3.81
|
9.5 number of repetitions
Standard Deviation 3.81
|
|
30 Second Chair Test
6 weeks
|
12.4 number of repetitions
Standard Deviation 13.75
|
11.1 number of repetitions
Standard Deviation 3.93
|
|
30 Second Chair Test
12 weeks
|
12.1 number of repetitions
Standard Deviation 4.31
|
13.0 number of repetitions
Standard Deviation 4.11
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: The variation in number analyzed is due to the actual number of participants with data collected at specific timepoint
The 36-question survey captures the Subject's perception of their general health by sorting them into multi-item scales that assess eight health concepts rather than a single total score. The survey used ten components to assess the health concepts: Physical, Mental, Physical Functioning, Role- Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Health Transition. Subject responses to the SF-36 survey were recorded. Scores can range from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Outcome measures
| Measure |
Treatment
n=73 Participants
Treatment with focused cold therapy.
iovera°: Use of iovera° device to administer treatment Focused Cold Therapy
|
Sham
n=75 Participants
Sham treatment with focused cold therapy device
iovera° Sham: iovera° device used for sham treatment
|
|---|---|---|
|
Change 36-Item Short Form Health Survey (SF-36) From Baseline to 6 Weeks
Role Emotional
|
0.7 change in score on a scale
Standard Deviation 32.61
|
7.4 change in score on a scale
Standard Deviation 34.62
|
|
Change 36-Item Short Form Health Survey (SF-36) From Baseline to 6 Weeks
Physical Component
|
3.8 change in score on a scale
Standard Deviation 7.70
|
6.3 change in score on a scale
Standard Deviation 9.58
|
|
Change 36-Item Short Form Health Survey (SF-36) From Baseline to 6 Weeks
Mental Component
|
0.7 change in score on a scale
Standard Deviation 10.73
|
0.3 change in score on a scale
Standard Deviation 10.61
|
|
Change 36-Item Short Form Health Survey (SF-36) From Baseline to 6 Weeks
Physical Functioning
|
13.6 change in score on a scale
Standard Deviation 23.83
|
16.7 change in score on a scale
Standard Deviation 28.49
|
|
Change 36-Item Short Form Health Survey (SF-36) From Baseline to 6 Weeks
Role-Physical Component
|
4.3 change in score on a scale
Standard Deviation 31.83
|
17.8 change in score on a scale
Standard Deviation 33.67
|
|
Change 36-Item Short Form Health Survey (SF-36) From Baseline to 6 Weeks
Bodily Pain Component
|
13.2 change in score on a scale
Standard Deviation 23.07
|
16.9 change in score on a scale
Standard Deviation 26.66
|
|
Change 36-Item Short Form Health Survey (SF-36) From Baseline to 6 Weeks
General Health Component
|
1.7 change in score on a scale
Standard Deviation 12.18
|
1.5 change in score on a scale
Standard Deviation 14.17
|
|
Change 36-Item Short Form Health Survey (SF-36) From Baseline to 6 Weeks
Vitality Component
|
3.2 change in score on a scale
Standard Deviation 20.15
|
4.2 change in score on a scale
Standard Deviation 17.78
|
|
Change 36-Item Short Form Health Survey (SF-36) From Baseline to 6 Weeks
Social Functioning Component
|
4.3 change in score on a scale
Standard Deviation 30.56
|
4.5 change in score on a scale
Standard Deviation 27.54
|
|
Change 36-Item Short Form Health Survey (SF-36) From Baseline to 6 Weeks
Health Transition Component
|
-0.5 change in score on a scale
Standard Deviation 1.13
|
-0.07 change in score on a scale
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: Baseline to 6 weeks after surgeryPopulation: The variation in number analyzed is due to the actual number of participants with data collected at specific timepoint
8 domains assessing physical, mental and social health while also covering important areas of self-reported health: pain, fatigue, depression, anxiety, sleep, and physical function. A high PROMIS domain sub-score indicates more of that concept being measured. PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. The referent population is usually the US General Population. lower scores are less favorable, and higher scores are more favorable.
Outcome measures
| Measure |
Treatment
n=73 Participants
Treatment with focused cold therapy.
iovera°: Use of iovera° device to administer treatment Focused Cold Therapy
|
Sham
n=75 Participants
Sham treatment with focused cold therapy device
iovera° Sham: iovera° device used for sham treatment
|
|---|---|---|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) From Baseline to Week 6
Physical Function
|
-2.3 score on a scale
Standard Deviation 4.36
|
-2.6 score on a scale
Standard Deviation 4.50
|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) From Baseline to Week 6
Anxiety
|
-1.0 score on a scale
Standard Deviation 3.17
|
-1.2 score on a scale
Standard Deviation 2.94
|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) From Baseline to Week 6
Depression
|
-0.3 score on a scale
Standard Deviation 2.47
|
0.1 score on a scale
Standard Deviation 2.85
|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) From Baseline to Week 6
Fatigue
|
9.6 score on a scale
Standard Deviation 3.74
|
8.7 score on a scale
Standard Deviation 3.79
|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) From Baseline to Week 6
Sleep Disturbance
|
0.1 score on a scale
Standard Deviation 1.83
|
0.22 score on a scale
Standard Deviation 1.98
|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) From Baseline to Week 6
Ability to Participate in Social Roles and Activities
|
-0.3 score on a scale
Standard Deviation 4.48
|
-0.6 score on a scale
Standard Deviation 3.83
|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) From Baseline to Week 6
Pain Interference
|
-2.5 score on a scale
Standard Deviation 4.55
|
-2.8 score on a scale
Standard Deviation 4.56
|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) From Baseline to Week 6
Pain Intensity
|
-2.6 score on a scale
Standard Deviation 2.8
|
-3.3 score on a scale
Standard Deviation 2.8
|
Adverse Events
Treatment
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
Sham
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=74 participants at risk
Treatment with focused cold therapy.
iovera°: Use of iovera° device to administer treatment Focused Cold Therapy
|
Sham
n=76 participants at risk
Sham treatment with focused cold therapy device
iovera° Sham: iovera° device used for sham treatment
|
|---|---|---|
|
Infections and infestations
Staphylococcal infection Left Hand
|
0.00%
0/74 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Infections and infestations
Incision site Cellulitis
|
1.4%
1/74 • Number of events 1 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
0.00%
0/76 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Investigations
Elevated white blood count
|
1.4%
1/74 • Number of events 1 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
0.00%
0/76 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Renal and urinary disorders
Acute Kidney Injury CKD Stage 3
|
0.00%
0/74 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
General disorders
Chest pain, left arm numbness
|
0.00%
0/74 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/74 • Number of events 1 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
0.00%
0/76 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Infections and infestations
Infection Left knee-Post TKA
|
1.4%
1/74 • Number of events 1 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
0.00%
0/76 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Infections and infestations
Subcutaneous abscess left buttocks
|
0.00%
0/74 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Gastrointestinal disorders
Left Inguinal Hernia
|
0.00%
0/74 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Vascular disorders
Hypotension
|
1.4%
1/74 • Number of events 1 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
0.00%
0/76 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Nervous system disorders
syncope
|
1.4%
1/74 • Number of events 1 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
0.00%
0/76 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
Other adverse events
| Measure |
Treatment
n=74 participants at risk
Treatment with focused cold therapy.
iovera°: Use of iovera° device to administer treatment Focused Cold Therapy
|
Sham
n=76 participants at risk
Sham treatment with focused cold therapy device
iovera° Sham: iovera° device used for sham treatment
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bursitis Knee
|
2.7%
2/74 • Number of events 2 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
2.6%
2/76 • Number of events 2 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Nervous system disorders
dizziness
|
4.1%
3/74 • Number of events 3 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
0.00%
0/76 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.1%
3/74 • Number of events 3 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Gastrointestinal disorders
Constipation
|
4.1%
3/74 • Number of events 3 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
2.6%
2/76 • Number of events 2 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Blood and lymphatic system disorders
Anemia
|
2.7%
2/74 • Number of events 2 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
1.3%
1/76 • Number of events 1 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Gastrointestinal disorders
Nausea
|
4.1%
3/74 • Number of events 3 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
3.9%
3/76 • Number of events 3 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Musculoskeletal and connective tissue disorders
knee arthralgia
|
2.7%
2/74 • Number of events 2 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
2.6%
2/76 • Number of events 2 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Infections and infestations
Cellulitis around incision
|
0.00%
0/74 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
3.9%
3/76 • Number of events 3 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
General disorders
peripheral edema of lower leg
|
2.7%
2/74 • Number of events 3 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
3.9%
3/76 • Number of events 3 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/74 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
3.9%
3/76 • Number of events 3 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Cardiac disorders
Atrial fibrillation
|
2.7%
2/74 • Number of events 2 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
0.00%
0/76 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.00%
0/74 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
2.6%
2/76 • Number of events 2 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.7%
2/74 • Number of events 2 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
0.00%
0/76 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
|
Musculoskeletal and connective tissue disorders
Hemarthrosis acute
|
0.00%
0/74 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
2.6%
2/76 • Number of events 2 • Adverse events were collected from Visit 2/Treatment through Visit 7/12 weeks post-op
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60