Trial Outcomes & Findings for Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System (NCT NCT02468934)
NCT ID: NCT02468934
Last Updated: 2018-09-04
Results Overview
Subjects were asked to complete daily diaries to track their average pain intensity while walking during the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average score for each diary period was calculated across subjects, and the mean scores for weeks 1-4 is reported.
COMPLETED
NA
24 participants
Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))
2018-09-04
Participant Flow
Recruitment began September 2015 (with first subject enrollment in October 2015) and was concluded in February 2017. Subjects were screened for the study from a pool of candidates scheduled to undergo a primary unilateral total knee replacement procedure.
After obtaining informed consent, subjects were evaluated for eligibility.
Participant milestones
| Measure |
Consented Subjects
These subjects signed an informed consent form and met all eligibility criteria.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
Enrolled/Received Leads
|
24
|
|
Overall Study
Underwent Total Knee Arthroplasty
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Consented Subjects
These subjects signed an informed consent form and met all eligibility criteria.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Screen Failure
|
3
|
Baseline Characteristics
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System
Baseline characteristics by cohort
| Measure |
Enrolled/Received Leads
n=24 Participants
This group includes subjects that were consented, met eligibility criteria, and received Leads.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
|
Affected Leg
Left Leg
|
10 Participants
n=5 Participants
|
|
Affected Leg
Right Leg
|
14 Participants
n=5 Participants
|
|
Reason for Total Knee Arthroplasty (TKA)
Osteoarthritis
|
24 Participants
n=5 Participants
|
|
Reason for Total Knee Arthroplasty (TKA)
Rheumatoid Arthritis
|
0 Participants
n=5 Participants
|
|
Reason for Total Knee Arthroplasty (TKA)
Trauma
|
0 Participants
n=5 Participants
|
|
Reason for Total Knee Arthroplasty (TKA)
Post-Traumatic Arthritis
|
0 Participants
n=5 Participants
|
|
Reason for Total Knee Arthroplasty (TKA)
Other
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))Subjects were asked to complete daily diaries to track their average pain intensity while walking during the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average score for each diary period was calculated across subjects, and the mean scores for weeks 1-4 is reported.
Outcome measures
| Measure |
Underwent Total Knee Arthroplasty (TKA)
n=20 Participants
These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
|
|---|---|
|
Average Knee Pain While Walking
|
3.8 Scores on a scale
Standard Error 0.34
|
PRIMARY outcome
Timeframe: Total of 21 months (from when the first subjects enrolled to when the last subject completed the study)At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition has occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.
Outcome measures
| Measure |
Underwent Total Knee Arthroplasty (TKA)
n=24 Participants
These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
|
|---|---|
|
Number of Participants That Experienced at Least One Study-Related Adverse Event
|
15 Participants
|
SECONDARY outcome
Timeframe: Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))Subjects were asked to complete daily diaries to track their average pain intensity in the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average score for each diary period was calculated across subjects, and the mean score for weeks 1-4 is reported.
Outcome measures
| Measure |
Underwent Total Knee Arthroplasty (TKA)
n=20 Participants
These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
|
|---|---|
|
Average Knee Pain Over the Last 24 Hours
|
3.5 Scores on a scale
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))Subjects were asked to complete daily diaries to track their average pain intensity at rest in the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average score for each diary period was calculated across subjects, and the mean score for weeks 1-4 is reported.
Outcome measures
| Measure |
Underwent Total Knee Arthroplasty (TKA)
n=20 Participants
These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
|
|---|---|
|
Average Knee Pain at Rest
|
2.9 Scores on a scale
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Visit 4 (Day of Surgery) and Visits 6-11 (weeks 1-6 post-Total Knee Arthroplasty (TKA))Population: Data was not available for: one subject during Post-op Week 1, three subjects for Weeks 2 and 4, four subjects during Weeks 3 and 5, and for seven subjects during Post-op Week 6.
The amount and type of analgesics used by subjects was recorded in daily diaries. Narcotic usage was converted into a morphine equivalent dosage (MED), which is measured in units of morphine milligram equivalents (MME). Diaries were collected at various visits throughout the study, and for consistency, these data were translated into post-operative days. The average MED was calculated for each subject for the first 42 days (6 weeks) following surgery, and the median of these averages was determined across subjects.
Outcome measures
| Measure |
Underwent Total Knee Arthroplasty (TKA)
n=20 Participants
These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
|
|---|---|
|
Amount of Analgesic Usage
|
15.9 MME (Morphine Milligram Equivalents)
Interval 7.0 to 33.8
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline), Visit 2 (Lead Placement), Visits 5-13 (in-hospital days through 3-months post-Total Knee Arthroplasty (TKA))Population: Data was not collected for: eight subjects at Visit 2, two subjects at Visit 10, and one subject at Visit 12.
Throughout the study, subjects were asked if they experienced any side effects related to opioid pain medications. The occurrences of these side effects were recorded and were not reported as Adverse Events. The number of subjects that experienced at least one opioid-related side effect at each visit is reported.
Outcome measures
| Measure |
Underwent Total Knee Arthroplasty (TKA)
n=20 Participants
These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
|
|---|---|
|
Number of Participants That Experienced at Least One Opioid-Related Side Effect
Visit 1 (Baseline)
|
7 Participants
|
|
Number of Participants That Experienced at Least One Opioid-Related Side Effect
Visit 2 (Lead Placement)
|
1 Participants
|
|
Number of Participants That Experienced at Least One Opioid-Related Side Effect
Visit 5 (In-Hospital)
|
13 Participants
|
|
Number of Participants That Experienced at Least One Opioid-Related Side Effect
Visit 6 (1-week Post-TKA)
|
17 Participants
|
|
Number of Participants That Experienced at Least One Opioid-Related Side Effect
Visit 7 (2-weeks Post-TKA)
|
11 Participants
|
|
Number of Participants That Experienced at Least One Opioid-Related Side Effect
Visit 8 (3-weeks Post-TKA)
|
11 Participants
|
|
Number of Participants That Experienced at Least One Opioid-Related Side Effect
Visit 9 (4-weeks Post-TKA)
|
9 Participants
|
|
Number of Participants That Experienced at Least One Opioid-Related Side Effect
Visit 10 (5-weeks Post-TKA)
|
7 Participants
|
|
Number of Participants That Experienced at Least One Opioid-Related Side Effect
Visit 11 (6-weeks Post-TKA)
|
4 Participants
|
|
Number of Participants That Experienced at Least One Opioid-Related Side Effect
Visit 12 (2-months Post-TKA)
|
2 Participants
|
|
Number of Participants That Experienced at Least One Opioid-Related Side Effect
Visit 13 (3-months Post-TKA)
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (Lead Placement), Visit 7 (3-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)Population: Three subjects did not meet 90 degrees of flexion with stimulation on by Visit 11 (End of Treatment) for both active range of motion (AROM) and passive range of motion (PROM). Data was not collected for four subjects for PROM with stimulation on and for three subjects for AROM with stimulation on.
Active range of motion (AROM; no assistance from clinical staff) and passive range of motion (PROM; assisted by clinical staff) was assessed with both stimulation on and off. The time that it took subjects to achieve the milestone of 90 degrees of knee flexion in their affected leg is reported.
Outcome measures
| Measure |
Underwent Total Knee Arthroplasty (TKA)
n=20 Participants
These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
|
|---|---|
|
Time to Achieve 90 Degrees Flexion in Affected Knee
PROM - Stimulation Off
|
40.0 days
Interval 16.0 to 44.0
|
|
Time to Achieve 90 Degrees Flexion in Affected Knee
PROM - Stimulation On
|
16.0 days
Interval 15.0 to 17.0
|
|
Time to Achieve 90 Degrees Flexion in Affected Knee
AROM - Stimulation Off
|
36.5 days
Interval 16.0 to 44.0
|
|
Time to Achieve 90 Degrees Flexion in Affected Knee
AROM - Stimulation On
|
16.0 days
Interval 15.0 to 17.0
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline), Visit 5 (In-Hospital), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)Population: Data was not collected for two subjects at Visit 5 and another subject was physically unable to complete the test. Data was not collected for one subject at Visit 7.
Subjects began this test from a seated position in a standard chair and were timed while they stood up, walked to a marked point 10 feet away (at a normal, safe pace), returned to the chair, and sat down. Timed Up and Go (TUG) test times are expected to be greater immediately after surgery as compared to baseline.
Outcome measures
| Measure |
Underwent Total Knee Arthroplasty (TKA)
n=20 Participants
These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
|
|---|---|
|
Timed Up and Go (TUG) Test
Time at Visit 1 (Baseline)
|
12.3 Seconds
Interval 11.0 to 14.0
|
|
Timed Up and Go (TUG) Test
Time at Visit 5 (In-Hospital)
|
39.0 Seconds
Interval 28.0 to 52.0
|
|
Timed Up and Go (TUG) Test
Time at Visit 7 (2-weeks Post-TKA)
|
13.9 Seconds
Interval 11.0 to 17.0
|
|
Timed Up and Go (TUG) Test
Time at Visit 11 (6-weeks Post-TKA)
|
10.5 Seconds
Interval 8.0 to 13.0
|
|
Timed Up and Go (TUG) Test
Time at Visit 13 (3-months Post-TKA)
|
8.7 Seconds
Interval 7.0 to 11.0
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)Population: One subject at Visit 1 and two subjects at Visit 7 were physically unable to complete the test. Data was not collected for an additional subject at Visit 7.
The total distance that a subject could walk in 6 minutes was recorded, and the mean distance was determined across subjects. 6 Minute Walk Test distances are expected to be reduced immediately after surgery as compared to baseline.
Outcome measures
| Measure |
Underwent Total Knee Arthroplasty (TKA)
n=20 Participants
These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
|
|---|---|
|
6 Minute Walk Test (6MWT)
Visit 1 (Baseline)
|
363.0 meters
Standard Error 15.14
|
|
6 Minute Walk Test (6MWT)
Visit 11 (6-weeks Post-TKA)
|
365.8 meters
Standard Error 17.87
|
|
6 Minute Walk Test (6MWT)
Visit 7 (2-weeks Post-TKA)
|
289.0 meters
Standard Error 21.55
|
|
6 Minute Walk Test (6MWT)
Visit 13 (3-months Post-TKA)
|
410.3 meters
Standard Error 16.78
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline) and Visit 5 (In-Hospital)Population: One subject at Visits 1 and 5 was physically unable to complete the test. Data was not collected for two additional subjects at Visit 5, and another subject walked a fixed distance greater than 20 meters during the test so their results are not comparable.
The amount of time it took subjects to walk a fixed distance of 20 meters was recorded.
Outcome measures
| Measure |
Underwent Total Knee Arthroplasty (TKA)
n=20 Participants
These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
|
|---|---|
|
Fixed Distance Walk Test
Visit 1 (Baseline)
|
18.1 seconds
Interval 17.0 to 22.0
|
|
Fixed Distance Walk Test
Visit 5 (In-Hospital)
|
48.5 seconds
Interval 44.0 to 72.0
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline), Visit 5 (In-Hospital), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)Population: Data was not collected for two subjects at Visit 5.
The Western Ontario McMaster University Osteoarthritis Index (WOMAC) questionnaire consists of 24 items that evaluate pain, stiffness, and physical functional disability. Each item is scored on an 11-point numerical rating scale from 0 to 10, where higher scores indicate greater pain, stiffness, and disability. For each subject, the scores from each of the 24 items were summed to calculate the subject's total score, with a minimum score of 0 and a maximum score of 240. Percent change from baseline was calculated for each subject at each time point (i.e., value at Visit 5 vs. Baseline rating, value at Visit 7 vs. Baseline rating, value at Visit 11 vs. Baseline rating, and value at Visit 13 vs. Baseline rating). The median percent change across subjects was determined. Negative values indicate worsening since Baseline, while positive values indicate improvement from Baseline. Percent improvement = 100 x (\[rating at each study visit\]-\[rating at baseline\]) / \[rating at baseline\].
Outcome measures
| Measure |
Underwent Total Knee Arthroplasty (TKA)
n=20 Participants
These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
|
|---|---|
|
Percent Change From Baseline on the Western Ontario McMaster University Osteoarthritis Index (WOMAC)
Visit 5 (In-Hospital)
|
-2.3 percent change
Interval -38.3 to 22.7
|
|
Percent Change From Baseline on the Western Ontario McMaster University Osteoarthritis Index (WOMAC)
Visit 7 (2-weeks Post-TKA)
|
39.0 percent change
Interval -24.1 to 58.3
|
|
Percent Change From Baseline on the Western Ontario McMaster University Osteoarthritis Index (WOMAC)
Visit 11 (6-weeks Post-TKA)
|
64.5 percent change
Interval 37.9 to 73.3
|
|
Percent Change From Baseline on the Western Ontario McMaster University Osteoarthritis Index (WOMAC)
Visit 13 (3-months Post-TKA)
|
88.5 percent change
Interval 68.9 to 96.8
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline), Visit 2 (Lead Placement), Visits 5-13 (in-hospital days through 3-months post-Total Knee Arthroplasty (TKA))Population: Data was not collected for: 10 subjects at Visit 2, two subjects at Visit 10, and one subject at Visit 12.
Subjects were asked to rate the degree to which their knee pain has interfered with 7 different aspects of their daily life on a scale from 0 to 10, with higher scores indicating greater interference. Those 7 scores were averaged for each subject to provide an overall pain interference score, with a possible range of 0 to 10 with higher scores indicating greater interference. The median score was then calculated across subjects.
Outcome measures
| Measure |
Underwent Total Knee Arthroplasty (TKA)
n=20 Participants
These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
|
|---|---|
|
Knee Pain Interference With Daily Activities
Visit 1 (Baseline)
|
4.2 Scores on a scale
Interval 1.7 to 6.6
|
|
Knee Pain Interference With Daily Activities
Visit 2 (Lead Placement)
|
4.4 Scores on a scale
Interval 2.7 to 6.6
|
|
Knee Pain Interference With Daily Activities
Visit 5 (In-Hospital)
|
3.6 Scores on a scale
Interval 3.0 to 5.2
|
|
Knee Pain Interference With Daily Activities
Visit 6 (1-week Post-TKA)
|
3.1 Scores on a scale
Interval 2.3 to 4.8
|
|
Knee Pain Interference With Daily Activities
Visit 7 (2-weeks Post-TKA)
|
3.1 Scores on a scale
Interval 2.1 to 5.3
|
|
Knee Pain Interference With Daily Activities
Visit 8 (3-weeks Post-TKA)
|
2.4 Scores on a scale
Interval 1.7 to 4.5
|
|
Knee Pain Interference With Daily Activities
Visit 9 (4-weeks Post-TKA)
|
3.6 Scores on a scale
Interval 1.8 to 5.3
|
|
Knee Pain Interference With Daily Activities
Visit 10 (5-weeks Post-TKA)
|
1.8 Scores on a scale
Interval 0.8 to 3.6
|
|
Knee Pain Interference With Daily Activities
Visit 11 (6-weeks Post-TKA)
|
1.5 Scores on a scale
Interval 0.4 to 2.6
|
|
Knee Pain Interference With Daily Activities
Visit 12 (2-months Post-TKA)
|
0.3 Scores on a scale
Interval 0.0 to 2.4
|
|
Knee Pain Interference With Daily Activities
Visit 13 (3-months Post-TKA)
|
0.1 Scores on a scale
Interval 0.0 to 0.3
|
SECONDARY outcome
Timeframe: Visits 5-13 (in-hospital through 3-months post-Total Knee Arthroplasty (TKA))Population: Data was not collected for two subjects at Visit 5, for three subjects at Visit 10, and for one subject at Visit 12.
The Patient Global Impression of Change (PGIC) asks subjects to rate their improvement with treatment on a 7-point scale ranging from "very much worse" to "very much improved" as compared to before their knee replacement surgery. The subjects combine all the components of their experience into one overall score. Ratings of Much- or Very Much Improved are considered Meaningful Improvements; similarly, ratings of Much- or Very Much Worse are categorized as Meaningfully Worse.
Outcome measures
| Measure |
Underwent Total Knee Arthroplasty (TKA)
n=20 Participants
These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
|
|---|---|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 13 (3-months Post-TKA) · Meaningfully Worse
|
0 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 5 (In-Hospital) · Meaningful Improvement
|
3 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 5 (In-Hospital) · Minimal or No Change
|
8 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 5 (In-Hospital) · Meaningfully Worse
|
7 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 6 (1-week Post-TKA) · Meaningful Improvement
|
6 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 6 (1-week Post-TKA) · Minimal or No Change
|
11 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 6 (1-week Post-TKA) · Meaningfully Worse
|
3 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 7 (2-weeks Post-TKA) · Meaningful Improvement
|
6 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 7 (2-weeks Post-TKA) · Minimal or No Change
|
11 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 7 (2-weeks Post-TKA) · Meaningfully Worse
|
3 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 8 (3-weeks Post-TKA) · Meaningful Improvement
|
9 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 8 (3-weeks Post-TKA) · Minimal or No Change
|
9 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 8 (3-weeks Post-TKA) · Meaningfully Worse
|
2 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 9 (4-weeks Post-TKA) · Meaningful Improvement
|
5 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 9 (4-weeks Post-TKA) · Minimal or No Change
|
13 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 9 (4-weeks Post-TKA) · Meaningfully Worse
|
2 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 10 (5-weeks Post-TKA) · Meaningful Improvement
|
8 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 10 (5-weeks Post-TKA) · Minimal or No Change
|
9 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 10 (5-weeks Post-TKA) · Meaningfully Worse
|
0 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 11 (6-weeks Post-TKA) · Meaningful Improvement
|
11 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 11 (6-weeks Post-TKA) · Minimal or No Change
|
7 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 11 (6-weeks Post-TKA) · Meaningfully Worse
|
2 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 12 (2-months Post-TKA) · Meaningful Improvement
|
15 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 12 (2-months Post-TKA) · Minimal or No Change
|
3 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 12 (2-months Post-TKA) · Meaningfully Worse
|
1 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 13 (3-months Post-TKA) · Meaningful Improvement
|
19 Participants
|
|
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
Visit 13 (3-months Post-TKA) · Minimal or No Change
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline), Visit 11 (6-weeks post-Total Knee Arthroplasty (TKA)), Visit 13 (3-months post-TKA)The Pain Catastrophizing Scale (PCS) questionnaire has 13 questions that assess rumination, magnification, and helplessness. Subjects are asked to think back on painful experiences in the past and reflect on how often they had specific thoughts or feelings. Each of the 13 questions is scored on a 5-point scale where 0 represents "not at all," and 4 represents "all the time." The scores from each question were summed for each subject to provide a total PCS score, with a possible range from 0 to 52 with higher scores indicating a greater tendency to catastrophize pain (i.e. a higher score indicates a worse outcome). The median scores were then calculated across all subjects.
Outcome measures
| Measure |
Underwent Total Knee Arthroplasty (TKA)
n=20 Participants
These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
|
|---|---|
|
Pain Catastrophizing Scale (PCS)
Visit 1 (Baseline)
|
5.5 Scores on a scale
Interval 0.8 to 11.3
|
|
Pain Catastrophizing Scale (PCS)
Visit 11 (6-weeks Post-TKA)
|
2.0 Scores on a scale
Interval 0.0 to 6.0
|
|
Pain Catastrophizing Scale (PCS)
Visit 13 (3-months Post-TKA)
|
0.0 Scores on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: From Day of Surgery through completion of milestone or 3-months from Day of Surgery, whichever came firstPopulation: Data were not available for climbing stairs and discharge destination for 3 subjects and for discharge criteria and clearance to drive for one. Data were not collected for clearance to work in 2 subjects, and 10 subjects were retired. Opioid cessation data were not collected for 1 subject, and 2 subjects did not cease opioids during the study.
Participants were queried weekly from the date of their Total Knee Arthroplasty (TKA) until they met specific, post-surgical recovery milestones. Participants were queried up through the time at which they meet each milestone or through their completion of the study, whichever came first (up to three months post-surgery).
Outcome measures
| Measure |
Underwent Total Knee Arthroplasty (TKA)
n=20 Participants
These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
|
|---|---|
|
Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA)
Pain controlled without nerve block
|
1.0 days
Interval 0.0 to 1.0
|
|
Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA)
Walked with assistive device
|
1.0 days
Interval 0.0 to 1.0
|
|
Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA)
Walked without assistive device
|
19.5 days
Interval 8.5 to 38.3
|
|
Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA)
Walked 30 meters
|
1.0 days
Interval 1.0 to 2.3
|
|
Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA)
Able to climb half flight of stairs
|
7.0 days
Interval 3.0 to 19.0
|
|
Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA)
Met hospital discharge criteria
|
1.0 days
Interval 1.0 to 3.0
|
|
Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA)
Discharged from hospital
|
1.5 days
Interval 1.0 to 3.0
|
|
Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA)
Cleared to drive
|
28.0 days
Interval 17.0 to 39.5
|
|
Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA)
Returned to work
|
24.0 days
Interval 13.8 to 34.5
|
|
Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA)
Cessation of all opioid medications
|
34.0 days
Interval 10.0 to 44.0
|
SECONDARY outcome
Timeframe: Visit 11 (6-weeks post-Total Knee Arthroplasty (TKA))Population: Two subjects did not answer the question regarding the amount of time it took to feel pain relief from stimulation.
Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the SPRINT Stimulation System as a method for managing post-surgical pain.
Outcome measures
| Measure |
Underwent Total Knee Arthroplasty (TKA)
n=20 Participants
These subjects were consented and met eligibility criteria, received leads, and underwent their scheduled Total Knee Arthroplasty (TKA) procedures.
|
|---|---|
|
Subject Satisfaction Survey
Tolerated Lead placement with some/no discomfort
|
17 Participants
|
|
Subject Satisfaction Survey
Reported stimulation felt comfortable/soothing
|
10 Participants
|
|
Subject Satisfaction Survey
Reported immediate pain relief (0-5 minutes)
|
8 Participants
|
|
Subject Satisfaction Survey
Would recommend stimulation therapy to a friend
|
12 Participants
|
|
Subject Satisfaction Survey
Prefer stimulation therapy to pain medication use
|
14 Participants
|
|
Subject Satisfaction Survey
Wanted stimulation for longer time period
|
1 Participants
|
Adverse Events
Enrolled/Received Leads
Serious adverse events
| Measure |
Enrolled/Received Leads
n=24 participants at risk
This group includes subjects that were consented, met eligibility criteria, and received Leads.
|
|---|---|
|
Gastrointestinal disorders
Ileus
|
4.2%
1/24 • Number of events 2 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
Other adverse events
| Measure |
Enrolled/Received Leads
n=24 participants at risk
This group includes subjects that were consented, met eligibility criteria, and received Leads.
|
|---|---|
|
Gastrointestinal disorders
Nausea/Upset Stomach
|
8.3%
2/24 • Number of events 2 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
General disorders
Agitation
|
12.5%
3/24 • Number of events 3 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
General disorders
Common Cold
|
4.2%
1/24 • Number of events 1 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Skin and subcutaneous tissue disorders
Small dehiscence at Total Knee Arthroplasty (TKA) surgical site
|
4.2%
1/24 • Number of events 1 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Musculoskeletal and connective tissue disorders
Iliotibial Band Tendonitis
|
4.2%
1/24 • Number of events 1 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Musculoskeletal and connective tissue disorders
Pulled Hamstring
|
4.2%
1/24 • Number of events 1 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain/Cramping
|
8.3%
2/24 • Number of events 4 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Musculoskeletal and connective tissue disorders
Increased Pain (Hip and Leg)
|
8.3%
2/24 • Number of events 3 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Product Issues
Pain due to Stimulation
|
4.2%
1/24 • Number of events 1 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Product Issues
Shocks at Lead Exit Site
|
8.3%
2/24 • Number of events 2 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Renal and urinary disorders
Urinary Frequency
|
4.2%
1/24 • Number of events 1 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Renal and urinary disorders
Urinary Tract Infection
|
4.2%
1/24 • Number of events 1 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Skin and subcutaneous tissue disorders
Skin irritation or bruising at Lead exit site
|
29.2%
7/24 • Number of events 8 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Skin and subcutaneous tissue disorders
Skin irritation/dermatitis from bandages
|
12.5%
3/24 • Number of events 3 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Skin and subcutaneous tissue disorders
Skin irritation from SPRINT Pad
|
16.7%
4/24 • Number of events 6 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Skin and subcutaneous tissue disorders
Non-specified skin irritation
|
12.5%
3/24 • Number of events 3 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Skin and subcutaneous tissue disorders
Bruising
|
4.2%
1/24 • Number of events 1 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Skin and subcutaneous tissue disorders
Itching
|
4.2%
1/24 • Number of events 1 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Vascular disorders
Affected Leg Swelling
|
4.2%
1/24 • Number of events 1 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
|
Musculoskeletal and connective tissue disorders
Knee Stiffness/Decreased Range of Motion
|
4.2%
1/24 • Number of events 1 • 21 months (from the time the first subject was enrolled to when the last subjects completed the study)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60