Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain

Not Applicable

Completed

Conditions: Osteoarthritis of the Knee

Interventions: Device: Cooled Radiofrequency
Other: Hyaluronic Acid Injection
Other: Crossover from Hyaluronic Acid Injection to Cooled Radiofrequency

Registration Number: NCT03381248

Lead Sponsor: Avanos Medical

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.

Detailed Description: The COOLIEF™ system components utilized in the study are the same in form and function regardless of specific product branding (COOLIEF\* or SInergy\*). The COOLIEF™ system is comprised of three primary components (collectively known as 'disposables') and is used in conjunction with the Pain Management generator, pump unit, connector cables (collectively known as 'Hardware') and dispersive electrodes (also known as 'grounding pads'):

* Cooled Radiofrequency Sterile Tube Kit (sterile, single use, non-body contact): It is used for closed-loop circulation of sterile water through a Halyard Health\* Cooled Radiofrequency Probe. It includes a burette and tubing.

* Cooled Radiofrequency Introducer (sterile, single use): It is to be used with the Probes only. The Cooled Radiofrequency Introducer provides a path for the Probe to the targeted nervous tissue.

* Cooled Radiofrequency Probe (sterile, single use): It is inserted through an Introducer into or near nervous tissue. The active tip extends 4mm from the introducer and delivers energy. Sterile water circulates internally to cool the Probe while it delivers radiofrequency energy. A thermocouple in the Probe measures the cooled electrode temperature throughout the procedure.

The product is comprised of an electrically insulated shaft with an active tip that functions as an electrode for radiofrequency energy delivery, a handle, tubes with luer locks and a cable with a 7-pin connector. The Introducer includes an insulated stainless steel cannula and a stylet. The Tube Kit is comprised of a burette and flexible tubing fitted with luer locks for connection to the Probe. The Probe, Introducer, and Tube Kit are ethylene oxide sterilized and supplied sterile. These components can be packaged together in a kit or as separate components. The devices should be stored in a cool, dry environment. The Instructions For Use (IFU) documents (Appendix 1) are included in each kit.

Halyard Health maintains a list of all model numbers and sizes for the system components.

The control product/device, Synvisc-One® (hylan G-F 20) (HA), is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Hylans are derivatives of hyaluronan (sodium hyaluronate). Hylan G-F 20 is unique in that the hyaluronan is chemically crosslinked. Hyaluronan is a long-chain polymer containing repeating disaccharide units of Na-glucuronate-N-acetylglucosamine.

Synvisc-One is a single injection regimen therapy indicated for the treatment of pain in Osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g., acetaminophen.

Following treatment, subjects in the CRF treatment group will follow up at 1, 3, 6 and 12 months. These subjects will then have the option to return for two additional visits at 18 and 24 months. Subjects initially randomized to the comparison (HA) group will follow up at 1, 3, and 6 months, and then be given the option to receive crossover CRF treatment. If crossover CRF treatment was received, subjects will return for follow up visits at 1, 3, and 6 months post-treatment. If crossover treatment was not received, subjects will return for their final 12 month visit.

Study Duration:

* Treatment Group: Up to 24 months following index procedure

* Control Group: Up to 13 months, depending upon receipt of cross-over procedure.

Effectiveness Endpoints:

* Numeric Rating Scale (NRS, Usual Level of Pain)

* Western Ontario \& McMaster University Osteoarthritis Index (WOMAC)

* EQ-5D-5L Health-Related Quality of Life Questionnaire

* Global Perceived Effect Scale

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 177

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic Acid, then Cooled Radiofrequency	Crossover from Hyaluronic Acid Injection to Cooled Radiofrequency	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.
Cooled Radiofrequency	Cooled Radiofrequency	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.
Hyaluronic Acid, then Cooled Radiofrequency	Hyaluronic Acid Injection	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.

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale (NRS)	Baseline to 6 month study visit	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.
Safety: The Proportion of Subjects Experiencing Adverse Events Through Final Follow up.	Baseline to 12 month study visit	Safety: The proportion of subjects experiencing adverse events through final follow up.

Secondary Outcome Measures

Name	Time	Method
Numeric Rating Scale	Baseline (or date of crossover for Crossover group subjects) to 12 month study visit	The proportion of subjects whose knee pain is reduced from baseline 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.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Baseline (or date of crossover for Crossover group subjects) to 12 month study visit	The change in WOMAC score from baseline to 12 months. This outcome instrument is composed of three sub-scales, including "Pain" (5 questions), "Stiffness" (2 questions), and "Physical Function" (17 questions). The point range for each sub-scale question is from 0 to 4, with "0" indicating the best study subject condition and "4" indicating the worst study subject condition. Thus, the minimum score per sub-scale is 0, and the maximum is 20, 8, and 68 for "Pain", Stiffness", and "Physical Function", respectively. The minimum and maximum possible scores for the entire instrument are 0 (best study subject condition) and 96 (worst study subject condition).

Trial Locations

Locations (9): Ocshner Baptist Clinical Trials Unit
🇺🇸
New Orleans, Louisiana, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Piedmont Comprehensive Pain Management
🇺🇸
Anderson, South Carolina, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Clinical Investigations, LLC
🇺🇸
Edmond, Oklahoma, United States
University Orthopedics Center
🇺🇸
State College, Pennsylvania, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
Virginia iSpine Physicians
🇺🇸
Richmond, Virginia, United States
Lyman Medical Research
🇺🇸
Coeur d'Alene, Idaho, United States