Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain

NCT04145011 | Completed FDA Device

• 1 other identifier: 105-18-0002
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 7

Brief Summary

This study is being performed to assess the relative effectiveness of genicular nerve ablation with the COOLIEF\* Cooled Radiofrequency probe to manage moderate to severe knee pain in patients with osteoarthritis (OA) of the knee when compared to radiofrequency ablation using a Standard Radiofrequency probe.

Conditions

Osteoarthritis of the Knee

Keywords

Randomized clinical trial; Osteoarthritis; Radiofrequency Ablation; Knee; Genicular; Coolief

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS)

  The proportion of subjects whose knee pain is reduced by ≥ 50% based on the NRS. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals "worst pain". There are no sub-scales.

  12 months

Secondary Outcomes (4)

• Additional Interventions

  12 months

• Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)

  12 months

• EQ-5D-5L

  12 months

• Global Perceived Effect (GPE)

  12 months

Other Outcomes (5)

• Numeric Rating Scale (NRS)

  24 months

• Additional Interventions

  24 months

• Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)

  24 months

Study Arms (2)

COOLIEF Cooled Radiofrequency Probe

EXPERIMENTAL

Cooled radiofrequency energy will be delivered to the study subjects' knee to ablate culprit sensory nerves and reduce knee pain

Device: Cooled Radiofrequency

Conventional (Standard) Radiofrequency Probe

ACTIVE COMPARATOR

Standard (non-cooled) radiofrequency energy will be delivered to the study subjects' knee to ablate culprit sensory nerves and reduce knee pain

Device: Standard Radiofrequency

Interventions

Cooled Radiofrequency DEVICE

Delivery of energy to ablate sensory nerves via cooled radiofrequency probe (18g, 4mm active tip)

Also known as: Coolief, CRFA

COOLIEF Cooled Radiofrequency Probe

Standard Radiofrequency DEVICE

Delivery of energy to ablate sensory nerves via non-cooled standard radiofrequency probe (22g, curved 10mm active tip)

Also known as: Conventional Radiofrequency, SRFA

Conventional (Standard) Radiofrequency Probe

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
• Able to understand and personally sign and date the informed consent form
• Able to complete outcome measures
• Chronic knee pain for longer than 6 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.)
• Continued pain in the target knee despite at least 3 months of conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs \[NSAIDs\])
• Positive response (defined as a decrease in numeric pain scores of at least 50%) to a single genicular nerve block of the index knee
• Pain on NRS ≥ 6 on an 11-point scale for the index knee
• Radiologic confirmation of osteoarthritis (x-ray/MRI/CT) grade 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee
• Analgesics including membrane stabilizers such as Neurontin (gabapentin) and antidepressants for pain, such as Cymbalta (duloxetine), must be clinically stable (defined as stable dosage for ≥ 6 weeks prior to the screening visit) and shall not change during the course of the study without approval of the investigator
• Agree to see one physician (study physician) for knee pain during the study period
• Subjects of child bearing potential must be willing to utilize double barrier contraceptive method
• Willingness to comply with the requirements of this protocol for the full duration of the study (24 months regardless of effect of initial therapy)

You may not qualify if:

• Evidence of inflammatory arthritis (example, rheumatoid arthritis) or other systemic inflammatory condition (example; gout, fibromyalgia, MS, Lupus, etc.) that could cause knee pain
• Evidence of neuropathic pain affecting the index knee
• Previous or pending lower limb amputation
• Intra-articular steroid injection into the index knee within 90 days from randomization
• Hyaluronic acid injection, platelet rich plasma (PRP), stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization
• Prior radiofrequency ablation of the genicular nerves of the index knee
• Prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware)
• Clinically significant ligamentous laxity of the index knee
• Clinically significant valgus/varus deformities or evidence of pathology (other than osteoarthritis of knee) that materially affects gait or function of the knee or is the underlying cause of the knee pain and/or functional limitations
• Body mass index (BMI) \> 40 kg/m2
• Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14 mm in diameter to limit the risk of skin burns
• Pending or active compensation claim, litigation, or disability remuneration (secondary gain)
• Pregnant, nursing or intent of becoming pregnant during the study period
• Chronic pain associated with significant psychosocial dysfunction
• Poorly controlled severe psychiatric illness or ongoing psychological barriers to recovery, as determined by the investigator

Sponsors & Collaborators

• Avanos Medical: lead

Study Sites (7)

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

Location

Pain Diagnostics and Interventional Care

Sewickley, Pennsylvania, 15143, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

Piedmont Comprehensive Pain Management

Anderson, South Carolina, 29621, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

The Spine and Nerve Centers of St. Francis Hosptial

Charleston, West Virginia, 25301, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• David Kennedy, MD

  Vanderbilt Stallworth Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study is a participant-blinded trial and deliberate action, utilizing a physical barrier, will be needed to ensure the blind remains intact.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: October 4, 2019
• Primary Completion: October 29, 2021
• Study Completion: October 10, 2022
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

US (7)