Active — Not RecruitingNot Applicable

Genicular Radiofrequency Ablation Following Total Knee Arthroplasty

Canada44 participantsStarted 2022-05-11

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 loca…

What they're measuring

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

Timeframe: 6 months

Change in pain intensity between pre- and 6-months post-intervention

Timeframe: 6 months

Trial details

NCT IDNCT05283889

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12