HF10 Treatment of Chronic Knee Pain

NCT04020211 | Terminated FDA Device

• 1 other identifier: CA2018-5 US CPSP-3
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Responders and Improvement in Oxford Knee Score (OKS)

  The OKS is a patient self-completion patient reported outcome containing 12 questions on activities of daily living with a recall period of 4 weeks. The OKS has been developed and validated specifically to assess function and pain after total knee replacement. The higher the score indicates improvement. The proportion of implanted subjects who are responders (achieved ≥ 50% pain relief) to HF10 therapy for treatment of their chronic, post-surgical knee pain or reporting at least a 4-point improvement in their Oxford Knee Score (OKS).

  3 months

Secondary Outcomes (11)

• Change in Disability and Functioning

  3, 6, and 12 months

• Change in Functioning

  3 and 12 months

• Change in Functioning

  3 and 12 months

• Change in pain relief as measured by the Visual Analog Scale (VAS)

  3 and 12 months

• Change from baseline in pain experience: Short-Form McGill Pain Questionnaire (SF-MPQ-2) scores

  3 and 12 months

Study Arms (1)

HF10

SCS stimulation with HF10 therapy

Device: Senza HF10 Therapy

Interventions

Senza HF10 Therapy DEVICE

Senza 10kHz Spinal Cord Stimulation

Also known as: Nevro Senza Spinal Cord Stimulation (SCS)

HF10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Have been diagnosed with chronic, focal, neuropathic pain following orthopedic surgery(ies) of the knee(s).
• 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.
• Have a score of at least 4 out of 10 in Douleur Neuropathique 4 (DN4) questionnaire at the time of enrollment or eligibility verification.
• Deemed not to have surgical loosening or other complications from the surgery that affect the stability of the knee.
• Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator.

You may not qualify if:

• Have radiculopathy or radicular leg pain resulting from failed back surgery.
• 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).
• 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.
• 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.
• Have any prior experience with SCS.
• Have objective evidence of epidural scarring and/or any signs or symptoms of myelopathy as determined by the investigator.
• Be benefitting from an interventional procedure to treat their trunk or limb pain (Subjects should be enrolled at least 30 days from last benefit).
• Have an existing drug pump and/or another active implantable device such as a pacemaker.
• Be involved in an injury claim under current litigation.
• Have an active or unsettled worker's compensation claim.

Sponsors & Collaborators

• Nevro Corp: lead

Study Sites (1)

Pain Management

Greenfield, Wisconsin, 53221, United States

Location

Study Officials

• David Caraway, MD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: July 15, 2019
• Study Start: March 14, 2019
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: November 12, 2020

Record last verified: 2020-11

Locations

US (1)