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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

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

No Placebo-Only Group

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.

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.

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

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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:

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I have had knee replacement surgery.

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I am unable to give my own consent due to a condition like dementia.

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I do not have any uncontrolled medical or mental health issues.

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I do not speak English.

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I am younger than 35 years old.

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I do not have any infections where the needle or probe will be placed.

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I cannot walk by myself.

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My knee arthritis is due to an autoimmune condition like rheumatoid or psoriatic arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Numeric Pain Rating Scale

PROMIS - Depression

PROMIS - Pain Interference

+1 more

Secondary study objectives

30-Second Chair Stand Test

40m Fast Paced Walk Test

Six Minute Walk Test

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 9Eligibility criteria met