Genicular Radiofrequency Ablation Following Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

— GRATKA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05283889
• Other study ID #: REB21-2105
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: University of Calgary
• Contact: Jennifer Laxshimalla
• Phone: 4032653838
• Email: jennifer.laxshimalla[@]vivocura.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Procedure:
• Genicular Radiofrequency Ablation
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 Ablation
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.

Locations

Country	Name	City	State
Canada	Vivo Cura Health	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (20)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Pain Intensity Over the Prior week (0 - 10)	Numerical pain rating scale (0 - 10) with higher scores indicating a worse outcome	6 months
Primary	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
Primary	Proportion of participants exceeding 50% pain relief	Proportion of participants that experience = 50% pain relief	6 months
Primary	Proportion of participants exceeding Minimal Clinically Important Difference (MCID) pain relief	Proportion of participants that experience MCID knee pain relief	6 months
Primary	Safety - Adverse Events	Presence of self-reported complications	1-week, 3, 6 and 12-months post-intervention
Secondary	Average Pain Intensity Over the Prior Week (0 - 10)	Numerical pain rating scale (0 - 10) with higher scores indicating worse outcomes	3 and 12-months post-intervention
Secondary	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	3, 6 and 12-months post-intervention
Secondary	The Clinical Global Impressions Scale (CGI)	Patient reported global impression of change (1 = Very Much Improved to 7 = Very Much Worse)	3, 6 and 12-months post-intervention
Secondary	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	Baseline (Prior to), 3, 6 and 12-months post-intervention
Secondary	Analgesic Use	Quantitative Analgesic Questionnaire	Baseline (Prior to), 3, 6 and 12-months post-intervention
Secondary	Health-related Quality of Life	EQ-5D-5L	Baseline (Prior to), 3, 6 and 12-months post-intervention