HF10 Treatment of Chronic Knee Pain | NCT04020211

NCT04020211

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
HF10		SCS stimulation with HF10 therapy	Device: Senza HF10 Therapy

Name	Type	Description	Arm Group Labels	Other Names
Senza HF10 Therapy	Device	Senza 10kHz Spinal Cord Stimulation	HF10

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change in Disability and Functioning	Percentage and average change from Baseline in Oxford Knee Score	3, 6, and 12 months
Change in Functioning	Average change in walking distance assessed by 6-minute Walk Test

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

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.
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:

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.