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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: Completed NA study of Osteoarthritis of the Knee, sponsored by Avanos Medical.
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 202-participant average among 16 other Osteoarthritis of the Knee trials with a reported enrollment target (12% lower). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT03381248 record still lists
NCT03381248 is an interventional study that assigns participants to a tested intervention. The registered 177 participants enrollment target is mid-sized for trials with a published cap, below the 202-participant average among 16 other Osteoarthritis of the Knee trials with a reported enrollment target (12% lower).
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 lists 10 locations in 7 states (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.
Learn More About Clinical Trials
Similar trials for Osteoarthritis of the Knee
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03381248's enrollment target sits among peer trials
177 9th of 16 higher than 8 of 16 other Osteoarthritis of the Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis of the Knee trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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