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NCT03381248 · ClinicalTrials.gov registry record · NA
Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain
A NA study of Osteoarthritis of the Knee, sponsored by Avanos Medical.
- Completed
- Registry status
- NA
- Development phase
- 177
- Enrollment target
- 10
- Study locations
NCT03381248 is a NA study of Osteoarthritis of the Knee that has completed, run by Avanos Medical. The registered enrollment target is 177 participants, below the 209-participant average among 15 other Osteoarthritis of the Knee trials with a reported enrollment target (15% lower). The trial reports 10 study locations across 7 states.
The verdict
NCT03381248, a NA study of Osteoarthritis of the Knee, has completed, sponsored by Avanos Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 177 participants
- Enrollment target
- 10
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 177 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 15 other Osteoarthritis of the Knee trials with a reported enrollment target (15% lower). The listed sponsor is Avanos Medical, which has 4 total studies on file at ClinicalTrials.gov.
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.
NCT03381248 reports 10 study locations spanning 7 distinct geographic areas - top geographies include Pennsylvania, Virginia, Idaho.
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.
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).
Who is sponsoring clinical trial NCT03381248?
This trial is sponsored by Avanos Medical, which has 4 total clinical trials registered on ClinicalTrials.gov.
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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Related
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