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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05130216
• Other study ID #: 144989
• Status: Enrolling by invitation
• Start date: September 22, 2021
• Est. completion date: September 2025

Study information

• Verified date: January 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Other:
• Genicular Nerve Radiofrequency Ablation
Radiofrequency Ablation (RFA)

Locations

Country	Name	City	State
United States	University of Utah Orthopaedic Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

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