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Radiofrequency Ablation
Radiofrequency Ablation for Chronic Knee Pain (RACKTKA Trial)
N/A
Recruiting
Led By Timothy E McAlindon, MD, MPH
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-, 3-, and 6-month visits
Summary
This triallooks at whether a nerve procedure is safe & helpful for knee pain after knee replacement surgery from arthritis.
Who is the study for?
This trial is for adults over 18 who've had knee replacement surgery at least a year ago and are in good health except for chronic knee pain. They must find their current state unacceptable, be willing to track pain daily, and not be on anticoagulants or pregnant. Those with infection in the knee or loose prosthesis, exclusive posterior knee pain, or less than 70% pain reduction after a test block can't join.
What is being tested?
The study tests genicular nerve radiofrequency ablation's effectiveness and safety against a sham procedure (placebo) in reducing chronic pain after total knee arthroplasty due to osteoarthritis. Participants will record their daily pain levels to measure outcomes.
What are the potential side effects?
Potential side effects may include temporary increased knee pain, numbness or skin tingling near the treated area, minor bleeding or bruising at the needle insertion site, and rare risks of infection or nerve damage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-, 3-, and 6-month visits
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-, 3-, and 6-month visits
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability by actively treated participants Outcome
Efficacy Outcome
Safety Outcome
Secondary study objectives
Chair Stand Test
Daily Step Count
Activation Analysis
+7 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Radiofrequency AblationActive Control1 Intervention
Patient undergoing genicular nerve radiofrequency ablation.
Group II: ShamPlacebo Group1 Intervention
Patient undergoing sham.
Find a Location
Who is running the clinical trial?
Tufts Medical CenterLead Sponsor
263 Previous Clinical Trials
264,438 Total Patients Enrolled
Boston UniversityOTHER
470 Previous Clinical Trials
9,987,718 Total Patients Enrolled
Timothy E McAlindon, MD, MPHPrincipal InvestigatorTufts Medical Center
1 Previous Clinical Trials
30 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My knee pain is only in the back of my knee.I am not pregnant, breastfeeding, and I am either post-menopausal or have had surgery to prevent pregnancy.I am over 18 and healthy except for chronic knee pain.I can stop my blood thinners for 3 days before the RFA procedure with my doctor's approval.I am willing to follow all study procedures and report my pain, side effects, and medication use daily.My knee implant is loose or I have an infection in my knee, as confirmed by my orthopedic surgeon.My pain did not reduce by 70% after the first treatment.It has been over a year since my knee replacement surgery.I have had knee pain, aching, or stiffness on most days for at least a month in the last 6 months.I am a woman who can have children and agree to use birth control during the study.I find my current state after joint replacement surgery unacceptable.
Research Study Groups:
This trial has the following groups:- Group 1: Radiofrequency Ablation
- Group 2: Sham
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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