Status:
WITHDRAWN
Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) After Knee Surgery
Lead Sponsor:
Stanford University
Collaborating Sponsors:
SPR Therapeutics, Inc.
Conditions:
Injury; Nerve, Peripheral, Multiple
Chronic Post-Procedural Pain
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 cove...
Eligibility Criteria
Inclusion
- At least 21 years old
- Underwent a primary or revision unilateral TKA
- Completed all CHOIR questionnaires before and after TKA surgery
- Persistent postsurgical knee pain ≥ 5 of 10 during ambulation as demonstrated on the CHOIR assessment.
- Must meet the definition of chronic pain.
- Pain that continues or is expected to continue for longer than 3 months from its initial onset or
- Persistent pain that at the discretion of the physician has not resolved within the normal time course of healing or
- Pain requiring opioid use beyond 30 days.
Exclusion
- Patients with a pre-operative history of moderate to high dose use of opioids (≥ 50 morphine milligram equivalents (MME) average per day)
- Patients taking opioids for reasons other than pain in knee that underwent TKA
- Patients with arthrofibrosis or indicated for manipulation under anesthesia
- BMI \>35
- Uncontrolled Diabetes Mellitus Types I or II, indicated by an HbA1c \>7.0% within the last 3 months
- Vulnerable population (e.g. pregnant women, prisoners, minors, or employees)
- Deep brain stimulation (DBS) system, an implanted active cardiac implant, or any other implantable neurostimulator whose stimulus current pathway may overlap the SPRINT stimulator's current pathway.
- Any other condition that may interfere with the ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement, nerve damage in affected leg, pain caused by knee implant requiring revision, compromised immune system) as determined by the Investigator
- Workers Compensation
Key Trial Info
Start Date :
June 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04670042
Start Date
June 25 2021
End Date
May 1 2024
Last Update
October 20 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford Pain Management Center
Redwood City, California, United States, 94063