Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain
Public ClinicalTrials.gov record NCT03381248. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03381248
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 177 participants
Conditions and interventions
Conditions
Interventions
- Cooled Radiofrequency Device
- Hyaluronic Acid Injection Other
- Crossover from Hyaluronic Acid Injection to Cooled Radiofrequency Other
Device · Other
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 6, 2017
- Primary completion
- Feb 7, 2019
- Completion
- Jul 19, 2020
- Last update posted
- Oct 9, 2023
2017 – 2020
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lyman Medical Research | Coeur d'Alene | Idaho | 83814 | — |
| Ocshner Baptist Clinical Trials Unit | New Orleans | Louisiana | 70115 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Clinical Investigations, LLC | Edmond | Oklahoma | 73013 | — |
| University Orthopedics Center | Altoona | Pennsylvania | 16602 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University Orthopedics Center | State College | Pennsylvania | 16801 | — |
| Piedmont Comprehensive Pain Management | Anderson | South Carolina | 29621 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Virginia iSpine Physicians | Richmond | Virginia | 23235 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03381248, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 9, 2023 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03381248 live on ClinicalTrials.gov.