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Osteoarthritis, KneeGRATKANCT05283889

Genicular Radiofrequency Ablation Following Total Knee Arthroplasty

A study testing Genicular Radiofrequency Ablation in people with Osteoarthritis, Knee, run by University of Calgary at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Genicular Radiofrequency Ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteCanada
Study dates
11 May 2022to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Vivo Cura Health

    Calgary, Alberta, T2E2P5

Other trials in Canada

About this study

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

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.

Read the 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 between group difference in the change in pain (NRS) between pre- and 6 months post. 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.

Being tested
Genicular Radiofrequency Ablation, Sham Genicular Radiofrequency Ablation
Keywords
Genicular Radiofrequency Ablation, Randomized Controlled Trial, Knee Pain, Balance
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genicular Radiofrequency AblationProcedure or surgery

    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.

  • Sham Genicular Radiofrequency AblationProcedure or surgery

    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.

Study groups in NCT05283889
Study groupRoleWhat they receive
Group 1 (GRFA)ExperimentalAfter 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.
Receives: Procedure: Genicular Radiofrequency Ablation
Group 2 (Sham)Active comparatorThe same procedure will be employed as per Group 1 - However, the sham procedure will involve no electrical signal applied to the participant.
Receives: Procedure: Sham Genicular Radiofrequency Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 6 months

  2. 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

    Measured: 6 months

Secondary outcomes (9)
  1. Average Pain Intensity Over the Prior Week (0 - 10)

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

    Measured: 3 and 12-months post-intervention

  2. Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Measure of pain (0 - 20), stiffness (0 - 8) and physical function (0 - 68) with higher scores indicating wore pain, stiffness and functional limitations

    Measured: 3, 6 and 12-months post-intervention

  3. The Clinical Global Impressions Scale (CGI)

    Patient reported global impression of change (1 = Very Much Improved to 7 = Very Much Worse)

    Measured: 3, 6 and 12-months post-intervention

  4. Safety - Adverse Events

    Presence of self-reported complications

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

  5. Proportion of participants exceeding 50% pain relief

    Proportion of participants that experience ≥ 50% pain relief

    Measured: 6 months

  6. Proportion of participants exceeding Minimal Clinically Important Difference (MCID) pain relief

    Proportion of participants that experience MCID knee pain relief

    Measured: 6 months

  7. Perceived Need for Revision Arthroplasty

    "If revision surgery of your knee replacement was available to you, how interested would you be in having it at this time?" Y or N

    Measured: Baseline (Prior to), 3, 6 and 12-months post-intervention

  8. Analgesic Use

    Quantitative Analgesic Questionnaire

    Measured: Baseline (Prior to), 3, 6 and 12-months post-intervention

  9. Health-related Quality of Life

    EQ-5D-5L

    Measured: Baseline (Prior to), 3, 6 and 12-months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2022
  2. Study start11 May 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05283889
Sponsor's protocol ID
REB21-2105
Acronym
GRATKA
Status last verified
Jan 2026
First submitted
18 Feb 2022
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Singh JA, Yu S, Chen L, Cleveland JD. Rates of Total Joint Replacement in the United States: Future Projections to 2020-2040 Using the National Inpatient Sample. J Rheumatol. 2019 Sep;46(9):1134-1140. doi: 10.3899/jrheum.170990. Epub 2019 Apr 15.

    PubMed 30988126
  • Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012.

    PubMed 22357571
  • Zhang H, Wang B, He J, Du Z. Efficacy and safety of radiofrequency ablation for treatment of knee osteoarthritis: a meta-analysis of randomized controlled trials. J Int Med Res. 2021 Apr;49(4):3000605211006647. doi: 10.1177/03000605211006647.

    PubMed 33887985
  • Li G, Zhang Y, Tian L, Pan J. Radiofrequency ablation reduces pain for knee osteoarthritis: A meta-analysis of randomized controlled trials. Int J Surg. 2021 Jul;91:105951. doi: 10.1016/j.ijsu.2021.105951. Epub 2021 Apr 18.

    PubMed 33882358
  • Chen AF, Mullen K, Casambre F, Visvabharathy V, Brown GA. Thermal Nerve Radiofrequency Ablation for the Nonsurgical Treatment of Knee Osteoarthritis: A Systematic Literature Review. J Am Acad Orthop Surg. 2021 May 1;29(9):387-396. doi: 10.5435/JAAOS-D-20-00522.

    PubMed 32701684
  • Protzman NM, Gyi J, Malhotra AD, Kooch JE. Examining the feasibility of radiofrequency treatment for chronic knee pain after total knee arthroplasty. PM R. 2014 Apr;6(4):373-6. doi: 10.1016/j.pmrj.2013.10.003. Epub 2013 Dec 27.

    PubMed 24373908
  • Kapural L, Lee N, Neal K, Burchell M. Long-Term Retrospective Assessment of Clinical Efficacy of Radiofrequency Ablation of the Knee Using a Cooled Radiofrequency System. Pain Physician. 2019 Sep;22(5):489-494.

    PubMed 31561648
  • Koshi E, Cheney CW, Sperry BP, Conger A, McCormick ZL. Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain Using a Three-Tined Electrode: A Technical Description and Case Series. Pain Med. 2020 Dec 25;21(12):3344-3349. doi: 10.1093/pm/pnaa204.

    PubMed 32984887
  • Erdem Y, Sir E. The Efficacy of Ultrasound-Guided Pulsed Radiofrequency of Genicular Nerves in the Treatment of Chronic Knee Pain Due to Severe Degenerative Disease or Previous Total Knee Arthroplasty. Med Sci Monit. 2019 Mar 12;25:1857-1863. doi: 10.12659/MSM.915359.

    PubMed 30858350
  • Qudsi-Sinclair S, Borras-Rubio E, Abellan-Guillen JF, Padilla Del Rey ML, Ruiz-Merino G. A Comparison of Genicular Nerve Treatment Using Either Radiofrequency or Analgesic Block with Corticosteroid for Pain after a Total Knee Arthroplasty: A Double-Blind, Randomized Clinical Study. Pain Pract. 2017 Jun;17(5):578-588. doi: 10.1111/papr.12481. Epub 2016 Sep 19.

    PubMed 27641918
  • Fonkoue L, Steyaert A, Kouame JK, Bandolo E, Lebleu J, Fossoh H, Behets C, Detrembleur C, Cornu O. A Comparison of Genicular Nerve Blockade With Corticosteroids Using Either Classical Anatomical Targets vs Revised Targets for Pain and Function in Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial. Pain Med. 2021 May 21;22(5):1116-1126. doi: 10.1093/pm/pnab014.

    PubMed 33772285
  • Tran J, Peng PWH, Lam K, Baig E, Agur AMR, Gofeld M. Anatomical Study of the Innervation of Anterior Knee Joint Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 May;43(4):407-414. doi: 10.1097/AAP.0000000000000778.

    PubMed 29557887
  • Cushman DM, Monson N, Conger A, Kendall RW, Henrie AM, McCormick ZL. Use of 0.5 mL and 1.0 mL of Local Anesthetic for Genicular Nerve Blocks. Pain Med. 2019 May 1;20(5):1049-1052. doi: 10.1093/pm/pny277. No abstract available.

    PubMed 30590798
  • Roos EM, Klassbo M, Lohmander LS. WOMAC osteoarthritis index. Reliability, validity, and responsiveness in patients with arthroscopically assessed osteoarthritis. Western Ontario and MacMaster Universities. Scand J Rheumatol. 1999;28(4):210-5. doi: 10.1080/03009749950155562.

    PubMed 10503556
  • Kreibich DN, Vaz M, Bourne RB, Rorabeck CH, Kim P, Hardie R, Kramer J, Kirkley A. What is the best way of assessing outcome after total knee replacement? Clin Orthop Relat Res. 1996 Oct;(331):221-5. doi: 10.1097/00003086-199610000-00031.

    PubMed 8895642

Questions about this trial

What is this clinical trial studying?

A study testing Genicular Radiofrequency Ablation in people with Osteoarthritis, Knee, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Pain Intensity Over the Prior week (0 - 10) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05283889, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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