Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty

A Single-arm Pilot Study of Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty

Determine if genicular nerve radiofrequency ablation (RFA) is a clinically effective intervention for patients with chronic knee pain post-total knee arthroplasty (TKA) as defined by pain.

Study Overview

• Status: Enrolling by invitation
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Other: Genicular Nerve Radiofrequency Ablation

Detailed Description

More than 600,000 total knee arthroplasty (TKA) surgeries are performed each year in the United States, and approximately 20% of patients will experience some element of chronic knee pain or dissatisfaction related to pain following this procedure. The options for management are limited, and physicians often resort to chronic opioid management. This creates a less than ideal situation for our elderly population who are more sensitive to the deleterious effects of opioids and who would greatly benefit from pain-free, independent mobility. The investigators propose a single-arm pilot study looking at performing fluoroscopically guided genicular nerve radiofrequency ablation (RFA) for patients with chronic (>6 months) knee pain following a TKA.

A new paradigm for treating post-TKA pain may be the use of RFA of the articular sensory nerve supply of the knee capsule, to desensitize the knee by blocking sensory afferents of the anterior capsule and thereby decreasing pain. While this modality has demonstrated efficacy for chronic knee pain due to osteoarthritis (OA) in the native knee, only one underpowered study has investigated this technique in chronic pain post-TKA. Further, this study targeted only three genicular nerves, while newer cadaveric studies have suggested multiple additional sensory nerves which if ablated may result in increased pain relief. A placebo-controlled explanatory trial of genicular nerve RFA for chronic pain post-TKA of appropriate size and statistical methodology has not been conducted.

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who have high pain following total knee replacement identified in clinic.

Description

Inclusion Criteria:

• Age 30 to 90 years
• At least one year post TKA
• Have no indications for revision TKA
• ≥4/10 knee pain for >6 months following TKA
• ≥80% relief with diagnostic genicular nerve blocks
• Willingness to undergo fluoroscopy-guided genicular nerve RFA treatment.

Exclusion Criteria:

• Conditions that preclude RFA (e.g. pregnancy, pacemaker/ICD, severe cardiac/pulmonary compromise; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic.
• Inability to write, speak or read in English
• Patient refusal
• Significant psychiatric comorbidity

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Total Knee Arthroplasty; Patients who have undergone total knee arthroplasty post one-year.	Other: Genicular Nerve Radiofrequency Ablation; Radiofrequency Ablation (RFA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric ranking scale (NRS) pain	NRS pain score (0 no pain - 10 severe pain)	Prior to nerve radiofrequency ablation (RFA)
Numeric ranking scale (NRS) pain	NRS pain score (0 no pain - 10 severe pain)	1-month post-genicular nerve RFA
Numeric ranking scale (NRS) pain	NRS pain score (0 no pain - 10 severe pain)	3-months post-genicular nerve RFA
Numeric ranking scale (NRS) pain	NRS pain score (0 no pain - 10 severe pain)	6-months post-genicular nerve RFA

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Lucas Anderson, MD, University of Utah Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2021
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Chronic Knee Pain; Genicular Nerve Radiofrequency Ablation
• Other Study ID Numbers: 144989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No