Genicular Radiofrequency Ablation Following Total Knee Arthroplasty

NCT05283889 | Active Not Recruiting

• 1 other identifier: REB21-2105
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Genicular Radiofrequency Ablation; Randomized Controlled Trial; Knee Pain; Balance

Outcome Measures

Primary Outcomes (2)

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

  Numerical pain rating scale (0 - 10) with higher scores indicating a worse outcome

  6 months

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

  Numerical Pain rating scale (NPRS) 6 month minus NPRS pre-intervention, with increased negative scores indicating a better outcome

  6 months

Secondary Outcomes (9)

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

  3 and 12-months post-intervention

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  3, 6 and 12-months post-intervention

• The Clinical Global Impressions Scale (CGI)

  3, 6 and 12-months post-intervention

• Safety - Adverse Events

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

• Proportion of participants exceeding 50% pain relief

  6 months

Study Arms (2)

Group 1 (GRFA)

EXPERIMENTAL

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.

Procedure: Genicular Radiofrequency Ablation

Group 2 (Sham)

ACTIVE COMPARATOR

The same procedure will be employed as per Group 1 - However, the sham procedure will involve no electrical signal applied to the participant.

Procedure: Sham Genicular Radiofrequency Ablation

Interventions

Genicular Radiofrequency Ablation PROCEDURE

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 1 (GRFA)

Sham Genicular Radiofrequency Ablation PROCEDURE

After the cannulae are placed and tines deployed, a single lesion (no electrical signal applied to patient) 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 2 (Sham)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Vivo Cura Health

Calgary, Alberta, T2E2P5, Canada

Location

Related Publications (20)

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MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ashley Smith, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Triple blinding will be accomplished as follows: operator (RF generator operated by assistant out of sight of operator); participant (local anesthetic administration and cannula placement identical; RF generator makes the same beeping sound for the same duration); assessor (only the study coordinator is aware of group assignment).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 17, 2022
• Study Start: May 11, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)