HF10 Treatment of Chronic Knee Pain

NCT ID: NCT04020211

Last Updated: 2020-11-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-14
• Study Completion Date: 2019-12-12

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.

Conditions

Chronic Pain Post-Procedural

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HF10

SCS stimulation with HF10 therapy

Senza HF10 Therapy

Intervention Type: DEVICE

Senza 10kHz Spinal Cord Stimulation

Interventions

Senza HF10 Therapy

Senza 10kHz Spinal Cord Stimulation

Intervention Type: DEVICE

Other Intervention Names

Nevro Senza Spinal Cord Stimulation (SCS)

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nevro Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Caraway, MD

Role: STUDY_DIRECTOR

Chief Medical Officer

Locations

Pain Management

Greenfield, Wisconsin, United States

Countries

United States

Other Identifiers

CA2018-5 US CPSP-3

Identifier Type: -

Identifier Source: org_study_id