At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multi-center, Randomized, Clinical Trial Evaluating the Safety and Effectiveness of Using COOLIEF™ Cooled Radiofrequency Probe to Create Lesions of the Genicular Nerves and Comparing a Single Injection of Hyaluronic Acid in the Management of Knee Pain
In Brief
A clinical study evaluating Cooled Radiofrequency, Hyaluronic Acid Injection, and 1 other intervention for Osteoarthritis of the Knee. Completed, enrolled 177 participants across 10 sites.
Detailed 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.
Study Details
Timeline
Interventions
Delivery of energy to ablate sensory nerves via cooled radiofrequency probe.
Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain.
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.