Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System

Not Applicable

Completed

Conditions: Pain
Postoperative Pain
Total Knee Arthroplasty
Orthopedic Disorders
Total Knee Replacement

Interventions: Device: SPRINT Peripheral Nerve Stimulation (PNS) System

Registration Number: NCT02468934

Lead Sponsor: SPR Therapeutics, Inc.

Brief Summary: The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce pain following total knee replacement (or total knee arthroplasty (TKA)). This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the leg that received the knee replacement. The SPRINT System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

Inclusion Criteria

At least 21 years old
Scheduled to undergo a primary unilateral total knee replacement procedure

Key

Exclusion Criteria

Body Mass Index (BMI) > 40 kg/m2
Compromised immune system based on medical history
History of valvular heart disease
Implanted electronic device
Joint or overlying skin infection of the affected limb
History of recurrent skin infections
Bleeding disorder
Allergy to skin surface electrodes and/or medical-grade adhesive tapes
Pregnant

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peripheral Nerve Stimulation	SPRINT Peripheral Nerve Stimulation (PNS) System	All study subjects will have up to 2 Smartpatch Leads placed in their leg that underwent total knee replacement, will use the SPRINT Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.

Primary Outcome Measures

Name	Time	Method
Average Knee Pain While Walking	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.
Number of Participants That Experienced at Least One Study-Related Adverse Event	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.

Secondary Outcome Measures

Name	Time	Method
Average Knee Pain Over the Last 24 Hours	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.
Average Knee Pain at Rest	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.
Amount of Analgesic Usage	Visit 4 (Day of Surgery) and Visits 6-11 (weeks 1-6 post-Total Knee Arthroplasty (TKA))	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.
Number of Participants That Experienced at Least One Opioid-Related Side Effect	Visit 1 (Baseline), Visit 2 (Lead Placement), Visits 5-13 (in-hospital days through 3-months post-Total Knee Arthroplasty (TKA))	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.
Time to Achieve 90 Degrees Flexion in Affected Knee	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)	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.
Timed Up and Go (TUG) Test	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)	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.
6 Minute Walk Test (6MWT)	Visit 1 (Baseline), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)	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.
Fixed Distance Walk Test	Visit 1 (Baseline) and Visit 5 (In-Hospital)	The amount of time it took subjects to walk a fixed distance of 20 meters was recorded.
Percent Change From Baseline on the Western Ontario McMaster University Osteoarthritis Index (WOMAC)	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)	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 (\[rating at each study visit\]-\[rating at baseline\]) / \[rating at baseline\].
Knee Pain Interference With Daily Activities	Visit 1 (Baseline), Visit 2 (Lead Placement), Visits 5-13 (in-hospital days through 3-months post-Total Knee Arthroplasty (TKA))	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.
Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey	Visits 5-13 (in-hospital through 3-months post-Total Knee Arthroplasty (TKA))	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.
Pain Catastrophizing Scale (PCS)	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.
Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA)	From Day of Surgery through completion of milestone or 3-months from Day of Surgery, whichever came first	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).
Subject Satisfaction Survey	Visit 11 (6-weeks post-Total Knee Arthroplasty (TKA))	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.

Trial Locations

Locations (3): Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Joint Implant Surgeons
🇺🇸
New Albany, Ohio, United States
University of California San Diego
🇺🇸
La Jolla, California, United States