Clinical Trials Directory

Trials / Completed

CompletedNCT05130216

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

Status
Completed
Phase
Study type
Observational
Enrollment
5 (actual)
Sponsor
University of Utah · Academic / Other
Sex
All
Age
30 Years – 90 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERGenicular Nerve Radiofrequency AblationRadiofrequency Ablation (RFA)

Timeline

Start date
2021-09-22
Primary completion
2025-10-01
Completion
2025-10-01
First posted
2021-11-23
Last updated
2026-01-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05130216. Inclusion in this directory is not an endorsement.