Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain
NCT03381248 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DEVICE Cooled Radiofrequency
- OTHER Hyaluronic Acid Injection
- OTHER Crossover from Hyaluronic Acid Injection to Cooled Radiofrequency
Study Locations (10)
Pennsylvania
- University Orthopedics Center — Altoona
- University of Pennsylvania — Philadelphia
- University Orthopedics Center — State College
Virginia
- University of Virginia — Charlottesville
- Virginia iSpine Physicians — Richmond
Idaho
- Lyman Medical Research — Coeur d'Alene
Louisiana
- Ocshner Baptist Clinical Trials Unit — New Orleans
Minnesota
- Mayo Clinic — Rochester
Oklahoma
- Clinical Investigations, LLC — Edmond
South Carolina
- Piedmont Comprehensive Pain Management — Anderson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2017-12-07 |
| Est. Completion | 2020-07-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03381248
The ClinicalTrials.gov registry entry for NCT03381248 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 177 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Avanos Medical, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Osteoarthritis of the Knee appearing as the primary indexed condition, and to 3 interventions — of which Cooled Radiofrequency is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03381248 reports 10 study locations spanning 7 distinct geographic areas — top geographies include Pennsylvania, Virginia, Idaho. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03381248 about?
NCT03381248 is a clinical study titled "Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain". 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 H...
What is the current status of trial NCT03381248?
This trial is currently completed. It is a NA study. The enrollment target is 177 participants. The study started on 2017-12-07. Estimated completion is 2020-07-20.
What conditions does trial NCT03381248 study?
This clinical trial studies the following conditions: Osteoarthritis of the Knee. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03381248?
The interventions under investigation include: Cooled Radiofrequency (DEVICE), Hyaluronic Acid Injection (OTHER), Crossover from Hyaluronic Acid Injection to Cooled Radiofrequency (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03381248?
This trial is sponsored by Avanos Medical, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03381248 being conducted?
This trial has 10 study locations across Idaho, Louisiana, Minnesota, Oklahoma, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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