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Procedure

cRFA Guidance Techniques for Knee Osteoarthritis

N/A
Recruiting
Led By Daniel Herman, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Reported NPRS pain intensity of at least four on most or all days of the past week
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the subjects will perform the oarsi-recommended performance-based functional tests at the baseline, three month, and six month time periods.
Awards & highlights

Study Summary

This trial will compare the efficacy of using cooled radiofrequency ablation guided by fluoroscopy versus ultrasound in treating knee osteoarthritis.

Who is the study for?
This trial is for adults with knee osteoarthritis who have pain most days of the week and haven't found relief from standard treatments like medications or physical therapy. They should have a Kellgren-Lawrence score of 2-4, indicating moderate to severe arthritis. It's not for those under 35, very overweight individuals (BMI over 40), those with previous knee surgeries or certain medical devices, non-English speakers, or anyone unable to consent.Check my eligibility
What is being tested?
The study tests whether using ultrasound guidance improves the accuracy and effectiveness of cooled radiofrequency ablation (cRFA) compared to traditional fluoroscopy guidance in treating geniculate nerve pain in knee osteoarthritis patients.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site, temporary increase in nerve pain, bleeding, infection risk at the needle entry point, and possible damage to surrounding tissues due to misplacement of the ablation probe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have experienced pain of at least a 4 out of 10 nearly every day last week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the subjects will perform the oarsi-recommended performance-based functional tests at the baseline, three month, and six month time periods.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the subjects will perform the oarsi-recommended performance-based functional tests at the baseline, three month, and six month time periods. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Numeric Pain Rating Scale
PROMIS - Depression
PROMIS - Pain Interference
+1 more
Secondary outcome measures
30-Second Chair Stand Test
40m Fast Paced Walk Test
Six Minute Walk Test
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subjects with knee OA using ultrasound for cRFA interventionExperimental Treatment1 Intervention
Knee osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve blocks will be enrolled and randomized to ultrasound (N=45) cRFA treatment arm.
Group II: Subjects with knee OA using fluoroscopy for cRFA interventionExperimental Treatment1 Intervention
Knee osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve blocks will be enrolled and randomized to fluoroscopic (N=45) cRFA treatment arm.

Find a Location

Who is running the clinical trial?

American Medical Society for Sports Medicine Collaborative Research NetworkUNKNOWN
University of FloridaLead Sponsor
1,338 Previous Clinical Trials
715,266 Total Patients Enrolled
14 Trials studying Osteoarthritis
11,045 Patients Enrolled for Osteoarthritis
University of California, DavisLead Sponsor
909 Previous Clinical Trials
4,704,040 Total Patients Enrolled
1 Trials studying Osteoarthritis
9 Patients Enrolled for Osteoarthritis

Media Library

cRFA (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04472702 — N/A
Osteoarthritis Research Study Groups: Subjects with knee OA using fluoroscopy for cRFA intervention, Subjects with knee OA using ultrasound for cRFA intervention
Osteoarthritis Clinical Trial 2023: cRFA Highlights & Side Effects. Trial Name: NCT04472702 — N/A
cRFA (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04472702 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What demographic is eligible for enrolling in this investigation?

"This medical study is seeking 90 participants, aged 35-99, suffering from knee osteoarthritis. To be considered eligible for the trial they must meet all of the following criteria: 1) diagnosis in accordance with American College of Rheumatology guidelines; 2) Kellgren-Lawrence score between two and four; 3) pain intensity reported as a minimum NPRS score of 4 on most days during the past week; 4) resistant to conventional treatments that may include medications (acetaminophen/NSAIDs/opioids), physical therapy or intra-articular injections (corticosteroids/hyaluronic acid"

Answered by AI

Is geriatric participation encouraged for this research trial?

"According to the eligibility standards of this clinical trial, individuals must be between 35 and 99 years old."

Answered by AI

In what maximum capacity are individuals participating in this research endeavor?

"This study necessitates the recruitment of 90 qualified patients. Potential applicants can come from UC Davis Health in Sacramento, California and UF and Shands Orthopaedics and Sports Medicine Institute in Gainesville, Florida."

Answered by AI

Are there vacancies in this medical experiment for participants?

"Affirmative. Clinicaltrials.gov offers evidence that this clinical research, originally published on February 2nd 2022, is actively enrolling participants. 90 individuals must be recruited across 3 distinct sites for the trial to continue as planned."

Answered by AI

What are the expected outcomes of this experiment?

"The primary measure of success for this study, assessed over a 24-month timeframe, is the Pain Interference score as determined by PROMIS. Secondary measures will observe patient performance in the 30-second Chair Stand Test (maximum repetitions within thirty seconds), 40m Fast Paced Walk Test (time to complete 4x10m walk) and Six Minute Walk Test (maximal distance covered)."

Answered by AI
~38 spots leftby Oct 2025