Dorsal Root Ganglion Stimulation for the Treatment of Arthritic Knee Pain

NCT05103527 | Active Not Recruiting FDA Device

• 1 other identifier: DRG-S for Knee OA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis; Knee Pain Chronic; Knee Arthritis; Knee Arthropathy

Keywords

Dorsal Root Ganglion Stimulation; knee pain; knee arthritis; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Treatment success rate at 3 months

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

  3 months post-implant

Secondary Outcomes (12)

• VAS pain scores

  1-, 3-, 6-, 9-, and 12 months post-implant

• Western Ontario and McMaster Universities Arthritis Index (WOMAC) for knee pain patients

  1-, 3-, 6-, 9-, and 12 months post-implant

• European Quality of Life 5 Dimension (EQ-5D)

  1-, 3-, 6-, 9-, and 12 months post-implant

• Short Form 36 Mental Component Summary (SF-36 MCS)

  1-, 3-, 6-, 9-, and 12 months post-implant

• Pain Disability Index (PDI)

  1-, 3-, 6-, 9-, and 12 months post-implant

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Up to 12 months post-implant

Study Arms (2)

Non-operated Knee Osteoarthritis

EXPERIMENTAL

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

Device: Dorsal Root Ganglion Stimulation

Surgically Repaired Knee Osteoarthritis

EXPERIMENTAL

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

Device: Dorsal Root Ganglion Stimulation

Interventions

Dorsal Root Ganglion Stimulation DEVICE

Stimulation at L2, L3, L4 and S1 spinal levels

Non-operated Knee Osteoarthritis; Surgically Repaired Knee Osteoarthritis

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 21 years old
• Able to provide informed consent
• Primary complaint of chronic knee pain for at least 1 year that interferes with functional activities
• Current pain score on visual analog scale (VAS) intensity ≥60 mm
• One of two groups: 1) Non-operated knee pain patients who want to pursue alternative therapies and delay surgery or are not candidates for knee arthroplasty based on age, frailty, non-operable condition, or poor outcome with other side arthroplasty, or 2) Post traumatic knee pain patients with history of surgical repair (such as meniscal or ligament repair).
• Radiologic confirmation (x-ray/MRI/CT) of Kellgren-Lawrence OA grade of 2 (mild) or 3 (moderate) or 4 (severe) noted within 6 months for the index knee
• Continued pain in the target knee despite at least 3 months of conservative treatments with documented failure of physical therapy and standard conservative therapy, including trials of at least two different classes of analgesic medication
• Failure of one or more prior interventional pain procedures such intraarticular corticosteroid or hyaluronidase knee injections, cooled radiofrequency ablation therapy, or regenerative medicine or prior surgery of the knee

You may not qualify if:

• Non-English speaking
• Douleur neuropathique 4 (DN4) score ≥4
• Receiving opioid analgesic medication at a dose of ≥90 mg oral morphine equivalents
• Workers' compensation or no-fault insurance
• Signs or symptoms of active infection in the index knee joint
• Pregnancy
• BMI \>45
• Presence of any contraindication for DRG stimulation, including neurological, medical, psychiatric, or social conditions.
• Widespread pain conditions like fibromyalgia
• Autoimmune/Inflammatory arthritic conditions such as Rheumatoid and psoriatic arthritis and other allied disorders (sjogren, felty, inflammatory bowl disease etc)
• Collagen diseases (systemic lupus erythematosus, Scleroderma, etc)
• Infectious arthritis
• Evidence of prespecified joint safety conditions (eg, rapidly progressive OA, subchondral insufficiency fracture, osteonecrosis, pathologic fracture) in the index knee on screening radiographs
• Scheduled for or anticipating any surgery during the trial period

Sponsors & Collaborators

• Kenneth B Chapman: lead
• Abbott: collaborator

Study Sites (1)

The Spine and Pain Institute of New York

New York, New York, 10305, United States

Location

Related Publications (7)

• Yu G, Segel I, Zhang Z, Hogan QH, Pan B. Dorsal Root Ganglion Stimulation Alleviates Pain-related Behaviors in Rats with Nerve Injury and Osteoarthritis. Anesthesiology. 2020 Aug;133(2):408-425. doi: 10.1097/ALN.0000000000003348.

  PMID: 32433276 BACKGROUND

• Bjerre-Bastos JJ, Bay-Jensen A-C, Karsdal MA, Byrjalsen I, Andersen JR, Riis BJ, et al. Biomarkers of bone and cartilage turnover CTX-I and CTX-II predict total joint replacements in osteoarthritis. Osteoarthr Cartil [Internet]. 2019;27(2019):S31-2. Available from: https://doi.org/10.1016/j.joca.2019.02.046

  BACKGROUND

• Convill JG, Tawy GF, Freemont AJ, Biant LC. Clinically Relevant Molecular Biomarkers for Use in Human Knee Osteoarthritis: A Systematic Review. Cartilage. 2021 Dec;13(1_suppl):1511S-1531S. doi: 10.1177/1947603520941239. Epub 2020 Jul 17.

  PMID: 32680434 BACKGROUND

• Adhikary SD, Liu WM, Memtsoudis SG, Davis CM 3rd, Liu J. Body Mass Index More Than 45 kg/m(2) as a Cutoff Point Is Associated With Dramatically Increased Postoperative Complications in Total Knee Arthroplasty and Total Hip Arthroplasty. J Arthroplasty. 2016 Apr;31(4):749-53. doi: 10.1016/j.arth.2015.10.042. Epub 2015 Nov 10.

  PMID: 26652477 BACKGROUND

• van Bussel CM, Stronks DL, Huygen FJPM. Dorsal Column Stimulation vs. Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome Confined to the Knee: Patients' Preference Following the Trial Period. Pain Pract. 2018 Jan;18(1):87-93. doi: 10.1111/papr.12573. Epub 2017 May 4.

  PMID: 28334499 BACKGROUND

• Kallewaard JW, Edelbroek C, Terheggen M, Raza A, Geurts JW. A Prospective Study of Dorsal Root Ganglion Stimulation for Non-Operated Discogenic Low Back Pain. Neuromodulation. 2020 Feb;23(2):196-202. doi: 10.1111/ner.12937. Epub 2019 Mar 1.

  PMID: 30821901 BACKGROUND

• Huygen F, Liem L, Cusack W, Kramer J. Stimulation of the L2-L3 Dorsal Root Ganglia Induces Effective Pain Relief in the Low Back. Pain Pract. 2018 Feb;18(2):205-213. doi: 10.1111/papr.12591. Epub 2017 Dec 6.

  PMID: 28486758 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: November 2, 2021
• Study Start: January 1, 2022
• Primary Completion: August 14, 2025
• Study Completion: May 1, 2026
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)