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Procedure
Radiofrequency Ablation for Osteoarthritis Post-Knee Replacement (GRATKA Trial)
N/A
Recruiting
Led By Ashley Smith, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥80% pain relief with a single fluoroscopically guided local anesthetic block using specified injections for various nerves
Refractory to conventional treatment (i.e., physiotherapy, medication, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-week, 3, 6 and 12-months post-intervention
Awards & highlights
GRATKA Trial Summary
This trial will be the first to evaluate the safety and efficacy of a minimally invasive percutaneous procedure called genicular radiofrequency ablation (GRFA) in patients with failed total knee arthroplasty (TKA).
Who is the study for?
This trial is for individuals who had knee replacement surgery at least a year ago and still experience significant pain (more than 4/10) despite treatments like physiotherapy or medication. They must have had major pain relief from a specific diagnostic nerve block. Exclusions include uncontrolled bleeding disorders, pregnancy, severe psychiatric conditions, pacemakers, certain allergies, and other specific medical issues.Check my eligibility
What is being tested?
The study tests Genicular Radiofrequency Ablation (GRFA), which uses heat to disrupt nerves causing knee pain after total knee arthroplasty (TKA). It's compared against a sham procedure to assess its safety and effectiveness in reducing persistent post-TKA pain using evidence-based techniques.See study design
What are the potential side effects?
While the side effects are not detailed here, GRFA may cause temporary soreness or swelling at the treatment site. There could also be risks of nerve damage or skin burns due to the thermal energy used.
GRATKA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experienced significant pain relief from a specific nerve block procedure.
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My condition did not improve with standard treatments like physiotherapy or medication.
Select...
It has been over a year since my knee replacement surgery.
Select...
I have had knee pain above 4 out of 10 in one of my knees after knee replacement surgery.
GRATKA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-week, 3, 6 and 12-months post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-week, 3, 6 and 12-months post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average Pain Intensity Over the Prior week (0 - 10)
Change in pain intensity between pre- and 6-months post-intervention
Proportion of participants exceeding 50% pain relief
+2 moreSecondary outcome measures
Analgesic Use
Average Pain Intensity Over the Prior Week (0 - 10)
Health-related Quality of Life
+3 moreGRATKA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1 (GRFA)Experimental Treatment1 Intervention
After the cannulae are placed and tines deployed, a single lesion (30 second ramp-up time; 80C x 2 minutes) will be made at each of the medial and lateral branches of the nerve to the vastus intermedialis, nerves to the vastus lateralis and medialis, recurrent fibular nerve, inferior medial genicular nerve. One bipolar strip lesion (intercannula distance 1.5 cm; anticipated strip lesion length 2.0 cm) at the superior medial and lateral genicular nerves will be made to accommodate anatomical variability.
Group II: Group 2 (Sham)Active Control1 Intervention
The same procedure will be employed as per Group 1 - However, the sham procedure will involve no electrical signal applied to the participant.
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Who is running the clinical trial?
University of CalgaryLead Sponsor
792 Previous Clinical Trials
869,110 Total Patients Enrolled
15 Trials studying Osteoarthritis
1,064 Patients Enrolled for Osteoarthritis
Ashley Smith, PhDPrincipal InvestigatorUniversity of Calgary
1 Previous Clinical Trials
6 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have leg pain from poor blood flow when I walk.I experienced significant pain relief from a specific nerve block procedure.My condition did not improve with standard treatments like physiotherapy or medication.I do not have a condition that causes uncontrolled bleeding.I do not have any infections, including skin or joint infections near my knee.It has been over a year since my knee replacement surgery.I have a condition affecting my joints or causing widespread pain.I am allergic to local anesthetics.My leg pain comes from my spine or joints, not my knee.I have had knee pain above 4 out of 10 in one of my knees after knee replacement surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 (GRFA)
- Group 2: Group 2 (Sham)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the clinical trial being participated in?
"Affirmative. The particulars on clinicaltrials.gov demonstrate that this research endeavour is presently recruiting participants. It was initially posted in May 11th, 2022 and modified for the last time on 16th of the same month. 44 individuals need to be drawn from a single medical centre."
Answered by AI
What primary objectives are researchers intending to achieve with this trial?
"This medical study, which is expected to span 6 months, has safety as its primary objective. It will also measure analgesic use with a Quantitative Analgesic Questionnaire, Health-related Quality of Life by the EQ-5D-5L scale and Western Ontario and McMaster Universities Arthritis Index (WOMAC). The WOMAC score incorporates pain level on a 0 - 20 scale, stiffness from 0 - 8 and physical function over 68 points; higher values indicate more severe symptoms."
Answered by AI
Are enrollments still open for this experiment?
"Correct. According to information procured from clinicaltrials.gov, this study is actively recruiting for 44 patients at one medical centre. It has been advertised since May 11th 2022 and was last updated on the 16th of that month."
Answered by AI
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