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Device
SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared) for Postoperative Pain
N/A
Waitlist Available
Led By Einar Ottestad
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Underwent a primary or revision unilateral TKA
Must meet the definition of chronic pain.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following tka
Awards & highlights
Study Summary
This trial will test a new pain management system for people who just had knee surgery. The system will be used for 60 days and may help relieve pain in the operated knee.
Eligible Conditions
- Postoperative Pain
- Chronic Knee Pain
- Post-Procedural Pain
- Peripheral Nerve Injury
- Knee Injuries
- Total Knee Replacement
- Surgery
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have completed the CHOIR questionnaire before and after TKA surgery.
Select...
You are 21 or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following tka
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following tka
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Pain Intensity from Baseline to 12 Months
Secondary outcome measures
Change in Opioid Use
Trial Design
1Treatment groups
Experimental Treatment
Group I: SPRINT® Peripheral Nerve Stimulation (PNS) SystemExperimental Treatment1 Intervention
SPRINT PNS System will be offered to patients with postoperative knee pain following primary unilateral total knee arthroplasty (TKA) who meet eligibility criteria and consistent with established coverage policy. SPRINT PNS System will be implanted for 60 days. At the discretion of the physician, the first lead may be placed to stimulate the nerve innervating the region of greatest pain. If pain is not adequately addressed by the first lead when assessed at 10 days, a second lead may be placed approximately 2 weeks following the initial lead placement.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,387 Previous Clinical Trials
17,334,050 Total Patients Enrolled
6 Trials studying Postoperative Pain
1,042 Patients Enrolled for Postoperative Pain
SPR Therapeutics, Inc.Industry Sponsor
11 Previous Clinical Trials
775 Total Patients Enrolled
3 Trials studying Postoperative Pain
127 Patients Enrolled for Postoperative Pain
Einar OttestadPrincipal Investigator - CLINICAL ASSOCIATE PROFESSOR, ANESTHESIOLOGY, PERIOPERATIVE AND PAIN MEDICINE
Baylor College Of Medicine (Medical School)
Stanford University Hospital (Residency)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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