← Back to Search

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
Must not have
Previous knee joint replacement surgery
Patients who are unable to provide their own consent (e.g. dementia)
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

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had knee replacement surgery.
Select...
I am unable to give my own consent due to a condition like dementia.
Select...
I do not have any uncontrolled medical or mental health issues.
Select...
I do not speak English.
Select...
I am younger than 35 years old.
Select...
I do not have any infections where the needle or probe will be placed.
Select...
I cannot walk by myself.
Select...
My knee arthritis is due to an autoimmune condition like rheumatoid or psoriatic arthritis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 24 months 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
1,354 Previous Clinical Trials
713,256 Total Patients Enrolled
15 Trials studying Osteoarthritis
11,075 Patients Enrolled for Osteoarthritis
University of California, DavisLead Sponsor
919 Previous Clinical Trials
4,720,802 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
~29 spots leftby Oct 2025