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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.)

Must not have

Peripheral vascular disease causing vascular claudication

Uncontrolled bleeding diathesis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-week, 3, 6 and 12-months post-intervention

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

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It has been over a year since my knee replacement surgery.

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I have had knee pain above 4 out of 10 in one of my knees after knee replacement surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have leg pain from poor blood flow when I walk.

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I do not have a condition that causes uncontrolled bleeding.

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I do not have any infections, including skin or joint infections near my knee.

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I have a condition affecting my joints or causing widespread pain.

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I am allergic to local anesthetics.

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My leg pain comes from my spine or joints, not my knee.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-week, 3, 6 and 12-months post-intervention for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

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 more

Secondary study objectives

Analgesic Use

Average Pain Intensity Over the Prior Week (0 - 10)

Health-related Quality of Life

+3 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

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.

0 / 10Eligibility criteria met