Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain

NCT03381248 | Completed Results FDA Device

• 1 other identifier: 105-17-0001
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 10

Brief Summary

This is a prospective, randomized, multicenter comparison study examining the outcomes of subjects with osteoarthritis and knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with the Cooled Radiofrequency Ablation (CRFA) system compared to subjects receiving Hyaluronic Acid (HA). Approximately 168 subjects will be enrolled into this study, with subjects undergoing either CRFA or HA injection in a 1:1 randomization scheme. Follow-up will be conducted for 12 months post-CRFA, with the primary endpoint being completed at month 6. Subjects randomized to the comparison (HA) group will have the option to cross-over to the neurotomy group after completing the 6-month endpoint assessment. They will be followed for an additional 6 months. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups to determine success. Subjects who were randomized to and received COOLIEF\* as their initial treatment will have the option to add 2 additional visits at 6-month intervals, representing 18 and 24 months post initial treatment.

Conditions

Osteoarthritis of the Knee

Keywords

randomized clinical trial; osteoarthritis; radiofrequency ablation; knee; genicular; cross-over; viscosupplementation

Outcome Measures

Primary Outcomes (2)

• 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 the "worst pain". There are no sub-scales.

  Baseline to 6 month study visit

• Safety: The Proportion of Subjects Experiencing Adverse Events Through Final Follow up.

  Safety: The proportion of subjects experiencing adverse events through final follow up.

  Baseline to 12 month study visit

Secondary Outcomes (3)

• Numeric Rating Scale

  Baseline (or date of crossover for Crossover group subjects) to 12 month study visit

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Baseline to 6 month study visit

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Baseline (or date of crossover for Crossover group subjects) to 12 month study visit

Other Outcomes (13)

• EQ-5D-5L

  Baseline to 6 month study visit

• EQ-5D-5L

  Baseline (or date of crossover for Crossover group subjects) to 12 month study visit

• Global Perceived Effect

  Baseline to 6 month study visit

Study Arms (2)

Cooled Radiofrequency

EXPERIMENTAL

Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain. Subjects in this group will be followed for 12 months post-procedure.

Device: Cooled Radiofrequency

Hyaluronic Acid, then Cooled Radiofrequency

ACTIVE COMPARATOR

Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain. Subjects in this group will have the option to crossover to receive cooled radiofrequency after 6-months. Crossover subjects will be followed for an additional 6 months post-procedure. Non-crossover subjects will continue to be followed until the 12-month timepoint.

Other: Hyaluronic Acid Injection; Other: Crossover from Hyaluronic Acid Injection to Cooled Radiofrequency

Interventions

Cooled Radiofrequency DEVICE

Delivery of energy to ablate sensory nerves via cooled radiofrequency probe.

Also known as: Coolief

Cooled Radiofrequency

Hyaluronic Acid Injection OTHER

Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain.

Also known as: Viscosupplementation

Hyaluronic Acid, then Cooled Radiofrequency

Crossover from Hyaluronic Acid Injection to Cooled Radiofrequency OTHER

Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain. After 6 months, qualifying subjects in this group will have the option to crossover to receive cooled radiofrequency treatment.

Also known as: Viscosupplementation, Cooled Radiofrequency

Hyaluronic Acid, then Cooled Radiofrequency

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 the informed consent form and provide written informed consent and 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 arthritis (x-ray/MRI/CT) of Osteoarthritis (OA) grade of 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee
• An intra-articular hyaluronic acid injection is indicated as an appropriate treatment option
• WOMAC Knee Score group at baseline of Score of ≥ 2 (0 to 4 scale) on WOMAC question 1 (Pain) and a mean score of ≥ 1.5 on all five questions of the WOMAC pain subscale.
• 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
• Willing to utilize double barrier contraceptive method if of child bearing potential.
• Willing to delay any surgical intervention for the index knee for the period of the study follow up
• Willingness to provide informed consent and to comply with the requirements of this protocol for the full duration of the study

You may not qualify if:

• Evidence of inflammatory arthritis (for example, rheumatoid arthritis) or other systemic inflammatory condition (for example, gout, fibromyalgia) 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 on becoming pregnant during the study period
• Chronic pain associated with significant psychosocial dysfunction
• Beck's Depression Index score of \> 22 (indicates clinically depressed state)

Sponsors & Collaborators

• Avanos Medical: lead

Study Sites (10)

Lyman Medical Research

Coeur d'Alene, Idaho, 83814, United States

Location

Ocshner Baptist Clinical Trials Unit

New Orleans, Louisiana, 70115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Clinical Investigations, LLC

Edmond, Oklahoma, 73013, United States

Location

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, 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 Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia iSpine Physicians

Richmond, Virginia, 23235, United States

Location

Related Publications (1)

• Chen AF, Khalouf F, Zora K, DePalma M, Kohan L, Guirguis M, Beall D, Loudermilk E, Pingree MJ, Badiola I, Lyman J. Cooled radiofrequency ablation provides extended clinical utility in the management of knee osteoarthritis: 12-month results from a prospective, multi-center, randomized, cross-over trial comparing cooled radiofrequency ablation to a single hyaluronic acid injection. BMC Musculoskelet Disord. 2020 Jun 9;21(1):363. doi: 10.1186/s12891-020-03380-5.

  PMID: 32517739 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Hyaluronic Acid; Viscosupplementation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Injections, Intra-Articular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Orthopedic Procedures

Results Point of Contact

• Title: David Curd
• Organization: Avanos Medical

david.curd@avanos.com

470-448-5178

Study Officials

• Antonia F Chen, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 21, 2017
• Study Start: December 7, 2017
• Primary Completion: February 8, 2019
• Study Completion: July 20, 2020
• Last Updated: October 10, 2023
• Results First Posted: May 22, 2020

Record last verified: 2023-09

Locations

US (10)