Clinical trial NCT05283889: Genicular Radiofrequency Ablation Following Total Knee Arthroplasty
Official title: The Safety and Efficacy of Genicular Radiofrequency Ablation for Patients With Persistent Knee Pain Following Total Knee Arthroplasty - A Triple Blinded Randomized Sham-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Genicular Radiofrequency Ablation
Randomized Controlled Trial
Knee Pain
Balance
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Currently, nearly 1 million total knee arthroplasties (TKA) are performed yearly in the United States. Three million are projected to be performed in 2040. Between 15-30% of all patients who undergo TKA have continued pain, reduced quality of life and functional impairments that cannot be attributed to hardware failure/loosening or infection. Treatment options for persistent post TKA pain (failed TKA) are limited. There is a need for minimally invasive, and effective pain and disability modulating interventions for patients with failed TKA. Genicular radiofrequency ablation (GRFA) has been described, refined, and validated as an effective minimally invasive intervention to control refractory knee pain secondary to knee osteoarthritis (OA) as evidenced by three favorable meta-analyses published in 2021 alone.3-5 GRFA is a minimally invasive percutaneous procedure that utilizes thermal energy to coagulate nerves from the knee. Though sometimes used in practice, there is limited research describing and evaluating GRFA for patients with failed TKA. This will be the first trial to evaluate the safety and efficacy of GRFA in patients with failed TKA using a robust study design and up-to-date, evidence-based selection criteria and technique.

Detailed description: The general objective of this study is to determine the safety and efficacy of GRFA in patients with failed TKA. The central hypothesis is that GRFA is safe and more efficacious in improving pain and function than sham GRFA. A triple blinded randomized sham-controlled trial design will be used. Patients with failed TKA will be recruited and randomized into either a thermal or sham GRFA group. Patient selection criteria and GRFA procedural technique will incorporate refinements based on expanded understanding from recent research. Outcomes will be assessed prior to and at 3, 6 and 12 months post-GRFA. The primary outcome measures will be change in pain (NRS). Secondary outcomes will include safety and changes in function (WOMAC; sit-stand test; strength; range of motion \& balance), participants' impression of change, perceived need for revision arthroplasty, analgesic use, and quality-of-life. Crossover will be offered to participants in the sham group at 6 months post-treatment. Data will be analyzed using descriptive, linear mixed-effects model and Kaplan-Meier Survival Curve statistics. The proposed research is innovative and important as it uses a robust study design to evaluate the safety and efficacy of an emerging RFA intervention in a prevalent suffering patient population.

Eligibility criteria: Inclusion Criteria:

* \>1 year post TKA
* persistent knee pain \> 4/10 in intensity on average over the prior week of one of the post-TKA knees
* refractory to conventional treatment (i.e., physiotherapy, medication, etc.)
* ≥80% pain relief with a single fluoroscopically guided local anesthetic block using 0.5 mL of 2% lidocaine for the medial and lateral branches of the nerve to the vastus intermedialis, nerve to the vastus lateralis\*, inferior medial genicular nerve, infrapatellar branch of the saphenous nerve, and the recurrent fibular nerve. 0.5 mL will be injected over 2 spots (1.5 cm apart) for each of the superior medial and lateral genicular nerves corresponding to the sites of the RF cannulae for the bipolar strip lesions. \*Blocks will be combined fluoroscopy/ultrasound guided.

Exclusion Criteria:

* Infection (peri-prosthetic, joint, systemic, skin/soft tissue overlying the knee to be treated)
* Prosthetic loosening or failure, periprosthetic fracture
* Severe psychiatric disorder
* Non-genicular lower extremity pain source from the spine (i.e., radiculopathy or neurogenic claudication) or peripheral joints (i.e., hip osteoarthritis)
* Peripheral vascular disease causing vascular claudication
* Connective tissue/inflammatory joint disease/widespread soft tissue pain disorder
* Poor tolerance of injection procedures (as observed from the prognostic local anesthetic blocks)
* Allergy to local anesthetic, synovial expansion into the anticipated path(s) of the local anesthetic needle/RF cannula as determined by ultrasound scanning
* Uncontrolled bleeding diathesis
* Pregnancy
* Pacemaker or neurostimulator
* Inability to complete Patient-Reported Outcome Measures due to cognitive or language limitations.

Primary outcomes:
measure: Average Pain Intensity Over the Prior week (0 - 10)
timeFrame: 6 months
measure: Change in pain intensity between pre- and 6-months post-intervention
timeFrame: 6 months
measure: Proportion of participants exceeding 50% pain relief
timeFrame: 6 months
measure: Proportion of participants exceeding Minimal Clinically Important Difference (MCID) pain relief
timeFrame: 6 months
measure: Safety - Adverse Events
timeFrame: 1-week, 3, 6 and 12-months post-intervention
Secondary outcomes:
measure: Average Pain Intensity Over the Prior Week (0 - 10)
timeFrame: 3 and 12-months post-intervention
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 3, 6 and 12-months post-intervention
measure: The Clinical Global Impressions Scale (CGI)
timeFrame: 3, 6 and 12-months post-intervention
measure: Perceived Need for Revision Arthroplasty
timeFrame: Baseline (Prior to), 3, 6 and 12-months post-intervention
measure: Analgesic Use
timeFrame: Baseline (Prior to), 3, 6 and 12-months post-intervention
measure: Health-related Quality of Life
timeFrame: Baseline (Prior to), 3, 6 and 12-months post-intervention
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Vivo Cura Health
state: Alberta
Study officials:
affiliation: University of Calgary
name: Ashley Smith, PhD
role: PRINCIPAL_INVESTIGATOR
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