Trials / Withdrawn
WithdrawnNCT04670042
Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) After Knee Surgery
Feasibility and Effectiveness of Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) Following Total Knee Arthroplasty.
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
- Injury; Nerve, Peripheral, Multiple
- Chronic Post-Procedural Pain
- Total Knee Arthroplasty
- Surgery
- Knee Injuries
- Knee Pain Chronic
- Postoperative Pain
- Chronic Postoperative Pain
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared) | Same as Arm Description. |
Timeline
- Start date
- 2021-06-25
- Primary completion
- 2022-08-01
- Completion
- 2024-05-01
- First posted
- 2020-12-17
- Last updated
- 2022-10-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04670042. Inclusion in this directory is not an endorsement.