Clinical trial NCT04020211: HF10 Treatment of Chronic Knee Pain
Official title: HF10 Therapy for the Treatment of Chronic, Focal, Neuropathic Pain Following Orthopedic Surgical Intervention of the Knee(s) - A Multicenter, Prospective Clinical Trial
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Pain Post-Procedural
Lead sponsor: Nevro Corp
Sponsor class: INDUSTRY
First posted: 2019-07-15
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who meet the eligibility criteria will be treated with HF10 therapy for their chronic knee pain post-orthopedic surgery.

Brief summary: This is a multi-center study where patients who meet the eligibility criteria will be treated with HF10 therapy for their chronic knee pain post-orthopedic surgery. The primary endpoint will be assessed at 3 months, but observational assessments will continue until study completion at 12 months following implant.


Eligibility criteria: Key Inclusion Criteria:

1. Have been diagnosed with chronic, focal, neuropathic pain following orthopedic surgery(ies) of the knee(s).
2. Average pain intensity (over a period of 7 days) of ≥5 out 10 cm on the Visual Analog Scale (VAS) in the primary area of pain at enrollment.
3. Have a score of at least 4 out of 10 in Douleur Neuropathique 4 (DN4) questionnaire at the time of enrollment or eligibility verification.
4. Deemed not to have surgical loosening or other complications from the surgery that affect the stability of the knee.
5. Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator.
6. Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to assessing pain intensity as described in inclusion criterion #2, and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device.

Key Exclusion Criteria:

1. Have radiculopathy or radicular leg pain resulting from failed back surgery.
2. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache diagnosis or fibromyalgia).
3. Have a current diagnosis of a progressive neurological disease such as multiple sclerosis (MS), chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, acute herniating disc, severe spinal stenosis and brachial plexus avulsion as determined by the Investigator.
4. Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the Investigator.
5. Have any prior experience with SCS.
6. Have objective evidence of epidural scarring and/or any signs or symptoms of myelopathy as determined by the investigator.
7. Be benefitting from an interventional procedure to treat their trunk or limb pain (Subjects should be enrolled at least 30 days from last benefit).
8. Have an existing drug pump and/or another active implantable device such as a pacemaker.
9. Be involved in an injury claim under current litigation.
10. Have an active or unsettled worker's compensation claim.

Primary outcomes:
measure: Responders and Improvement in Oxford Knee Score (OKS)
timeFrame: 3 months
Secondary outcomes:
measure: Change in Disability and Functioning
timeFrame: 3, 6, and 12 months
measure: Change in Functioning
timeFrame: 3 and 12 months
measure: Change in Functioning
timeFrame: 3 and 12 months
measure: Change in pain relief as measured by the Visual Analog Scale (VAS)
timeFrame: 3 and 12 months
measure: Change from baseline in pain experience: Short-Form McGill Pain Questionnaire (SF-MPQ-2) scores
timeFrame: 3 and 12 months
measure: Global Impression of Change
timeFrame: 3 and 12 months
measure: Change in Quality of Life as measured by the EuroQol five-dimensional questionnaire (EQ-5D-5L)
timeFrame: 3 and 12 months
measure: Change in Sleep as measured by the Pain and sleep Questionnaire (PSQ)
timeFrame: 3 and 12 months
measure: Medication
timeFrame: 3 and 12 months
measure: Safety profile: Incidence of AEs over time
timeFrame: 3, 6 and 12 months
measure: Safety profile: Neurological assessment over time by a physician and exam
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Greenfield
country: United States
facility: Pain Management
state: Wisconsin
Study officials:
affiliation: Chief Medical Officer
name: David Caraway, MD
role: STUDY_DIRECTOR
References: