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DRG-S for knee osteoarthritis patients with no history of knee surgery

DRG-S for knee osteoarthritis patients with history of surgical repair of the knee

Stimulation at L2, L3, L4 and S1 spinal levels

Dorsal Root Ganglion Stimulation

Kenneth B Chapman, MD

Tariq a Yousef, MD

Ahmad Amireh, BS

Dorsal root ganglion stimulation (DRG-S) may be able to treat mechanical pain caused by tissue injury or damage such as trauma or arthritis in addition to pain caused by nerve dysfunction or injury. The purpose of this study is to determine if dorsal root ganglion stimulation (DRG-S) can effectively treat arthritic pain of the knee.

Dorsal root ganglion stimulation (DRG-S) is a novel form of neuromodulation used to treat chronic neuropathic pain of the groin and lower extremities related to complex regional pain syndrome type I or II (causalgia). DRG-S has shown promise in treating traditionally mixed neuropathic and mechanical pain syndromes such as axial low back pain, suggesting DRG-S may be able to treat mechanical pain in addition to neuropathic pain. Additionally, in a rodent model of osteoarthritis of the knee, DRG-S alleviated pain related behavior in rats.

This open label feasibility study seeks to evaluate if dorsal root ganglion stimulation with Abbott's Proclaim Dorsal Root Ganglion Neurostimulator System can effectively treat osteoarthritis of the knee. Patients with either osteoarthritis of the non-operated knee or osteoarthritis of the surgically repaired knee will be trialed for one week with dorsal root ganglion stimulation to determine if they positively respond with 50% or greater pain relief. For those patients that have a successful trial, they will be implanted with a permanent stimulation device system and followed for one year post implant to measure knee pain, function and disability, and other related outcomes with sustained DRG-S therapy.

Patients will be seen and evaluated prior to DRG-S trial, and for those that receive permanent implants, re-evaluated at 1, 3, 6, 9 and 12 months after implant.

Subjects will undergo one week DRG-S trial, and for those that respond as defined by 50% or greater pain relief, proceed to DRG-S permanent device system implant

Dorsal Root Ganglion Stimulation for the Treatment of Arthritic Knee Pain

Dorsal Root Ganglion Stimulation Outcomes for the Treatment of Mechanical Knee Pain Among Patients With Osteoarthritis of the Surgical and Non-surgical Knee

All complications of DRG-S trial, implant, and stimulation therapy will be reported

Percent of DRG-S implanted patients that successfully respond to stimulation therapy as defined by \>=50% reduction in reported pain score from baseline

Patient's pain score using standard 10cm pain scale that represents a continuum between "no pain" and "worst pain."

At each study visit, subjects will complete WOMAC survey which assesses pain, stiffness, and function in patients with OA of the knee.

At each study visit, subjects will complete EQ-5D survey which assesses health-related quality of life

At each study visit, subjects will complete SF-36 MCS survey which assesses mental health

At each study visit, subjects will complete PDI survey which assesses pain-related disability

At each study visit, subjects will complete PDI survey which assesses patient's belief about the efficacy of treatment

Patient's dose of narcotic analgesics measured in morphine milligram equivalents (MME) and non-narcotic analgesics and dosages

Video recordings of motor task exams will be used to measure TUG, a performance-based measure of functional mobility which measures the time for subject to rise from a chair, walk three meters, turn around, return to the chair, and sit down.

Video recordings of motor task exams will be used to measure ROM of the index knee

Serum concentrations of molecular biomarkers related to knee OA including but not limited to C-telopeptide of crosslinked collagen type I and type II (CTX-I and CTX-II)

Radiologic classification of subject's knee x-ray to grade progression/severity of osteoarthritis

Spots Global Cancer Trial Database for knee arthropathy