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

NCT ID: NCT04145011

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-04
• Study Completion Date: 2022-10-10

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.

Detailed Description

This is a prospective, multi-center, randomized, single-blind comparison study examining the outcomes of subjects with osteoarthritic knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with either Cooled Radiofrequency Ablation (CRFA) or Conventional (Standard) Radiofrequency Ablation (SRFA). Approximately 148 participants from up to 15 sites will be enrolled into this study, with subjects undergoing either CRFA or SRFA in a 1:1 randomization scheme. Follow-up will be conducted for 24 months post-treatment, with the primary endpoint being completed at month 12. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups to determine success.

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

COOLIEF Cooled Radiofrequency Probe

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

Group Type: EXPERIMENTAL

Cooled Radiofrequency

Intervention Type: DEVICE

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

Conventional (Standard) Radiofrequency Probe

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

Group Type: ACTIVE_COMPARATOR

Standard Radiofrequency

Intervention Type: DEVICE

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

Interventions

Cooled Radiofrequency

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

Intervention Type: DEVICE

Standard Radiofrequency

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

Intervention Type: DEVICE

Other Intervention Names

Coolief, CRFA; Conventional Radiofrequency, SRFA

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 21 years

2. Able to understand and personally sign and date the informed consent form

3. Able to complete outcome measures

4. Chronic knee pain for longer than 6 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.)

5. 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])

6. Positive response (defined as a decrease in numeric pain scores of at least 50%) to a single genicular nerve block of the index knee

7. Pain on NRS ≥ 6 on an 11-point scale for the index knee

8. Radiologic confirmation of osteoarthritis (x-ray/MRI/CT) grade 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee

9. 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

10. Agree to see one physician (study physician) for knee pain during the study period

11. Subjects of child bearing potential must be willing to utilize double barrier contraceptive method

12. Willingness to comply with the requirements of this protocol for the full duration of the study (24 months regardless of effect of initial therapy)

Exclusion Criteria

1. Evidence of inflammatory arthritis (example, rheumatoid arthritis) or other systemic inflammatory condition (example; gout, fibromyalgia, MS, Lupus, etc.) that could cause knee pain

2. Evidence of neuropathic pain affecting the index knee

3. Previous or pending lower limb amputation

4. Intra-articular steroid injection into the index knee within 90 days from randomization

5. Hyaluronic acid injection, platelet rich plasma (PRP), stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization

6. Prior radiofrequency ablation of the genicular nerves of the index knee

7. Prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware)

8. Clinically significant ligamentous laxity of the index knee

9. 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

10. Body mass index (BMI) > 40 kg/m2

11. 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

12. Pending or active compensation claim, litigation, or disability remuneration (secondary gain)

13. Pregnant, nursing or intent of becoming pregnant during the study period

14. Chronic pain associated with significant psychosocial dysfunction

15. Poorly controlled severe psychiatric illness or ongoing psychological barriers to recovery, as determined by the investigator

16. Allergies to any of the medications to be used during the procedures

17. Active joint infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved)

18. History of uncontrolled coagulopathy, ongoing coagulation treatment that cannot be safely interrupted for procedure, or unexplained or uncontrollable bleeding that is uncorrectable

19. Identifiable anatomical variability that would materially alter the procedure as described in the protocol

20. Within the preceding 2 years, subject has suffered from active narcotic addiction, substance, or alcohol abuse

21. Current prescribed opioid medications greater than 60 mg morphine equivalent daily opioid dose

22. Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.)

23. Subject currently implanted with pacemaker, stimulator or defibrillator

24. Participating in another clinical trial/investigation which included therapeutic treatment within 30 days prior to signing informed consent

25. Subject unwilling or unable to comply with follow up schedule, protocol requirements or procedures

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avanos Medical

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Kennedy, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Stallworth Rehabilitation Hospital

Locations

University Orthopedics Center

Altoona, Pennsylvania, United States

Pain Diagnostics and Interventional Care

Sewickley, Pennsylvania, United States

University Orthopedics Center

State College, Pennsylvania, United States

Piedmont Comprehensive Pain Management

Anderson, South Carolina, United States

University of Utah

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

The Spine and Nerve Centers of St. Francis Hosptial

Charleston, West Virginia, United States

Countries

United States

Other Identifiers

105-18-0002

Identifier Type: -

Identifier Source: org_study_id