An observational study in Osteoarthritis, Knee and Osteoarthritis, sponsored by Wake Forest University Health Sciences. Terminated at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-11-06.
Sponsored by Wake Forest University Health Sciences · Observational
The purpose of this study is to demonstrate the treatment outcomes of patients with chronic knee pain secondary to osteoarthritis that have received a temporary peripheral nerve stimulation system.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's enrollment of 12 is below the median of 100 across 472 observational studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Study population includes patients with chronic knee pain secondary to osteoarthritis of the knee and will receive a temporary peripheral nerve stimulation device.
Exclusion Criteria:
These patients will receive a temporary PNS system for their knee pain secondary to osteoarthritis
Device: Temporary PNS system
This system remains in place up to 60 days, then removed.
Also known as: SPRINT PNS System
Average change from baseline to end of treatment in average pain intensity measured through BPI-SF item 5.
Time frame: up to 60 days post lead placement
Average change from baseline to end of treatment in health-related quality of life measured through PROMIS-29.
Time frame: up to 60 days post lead placement
Average change from baseline to end of treatment in pain interference measured through BPI-SF.
Time frame: up to 60 days post lead placement
Average change in chronic pain related medication intake at end of treatment compared to baseline in Morphine Miligram Equivalents (MME)
Time frame: up to 60 days post lead placement
Overall patient global impression of change (PGIC) at end of treatment.
Time frame: up to 60 days post lead placement
Overall incidence of lead migration/fracture at the end of treatment.
Time frame: up to 60 days post lead placement
Average change from baseline to 7- and 30-days post-implant; and 6- and 12-months post-explant in average pain intensity measured through BPI-SF item 5.
Time frame: 7 and 30 days post lead placement; and 6 and 12 month post lead pull
Average change from baseline to 6- and 12-months post-explant in health-related quality of life measured through PROMIS-29.
Time frame: 7 and 30 days post lead placement; and 6 and 12 month post lead pull
Average change from baseline to 6- and 12-months post-explant in pain interference measured through BPI-SF.
Time frame: 7 and 30 days post lead placement; and 6 and 12 month post lead pull
Overall patient global impression of change (PGIC) at 6 months and end of study.
Time frame: 6 and 12 months post lead pull
Overall incidence of lead migration/fracture during the study.
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences