Clinical trial NCT05130216: Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
Official title: A Single-arm Pilot Study of Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Total Knee Arthroplasty
Keywords: Genicular Nerve Radiofrequency Ablation
Total Knee Arthroplasty
Chronic Knee Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have high pain following total knee replacement identified in clinic.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric ranking scale (NRS) pain
timeFrame: Prior to nerve radiofrequency ablation (RFA)
measure: Numeric ranking scale (NRS) pain
timeFrame: 1-month post-genicular nerve RFA
measure: Numeric ranking scale (NRS) pain
timeFrame: 3-months post-genicular nerve RFA
measure: Numeric ranking scale (NRS) pain
timeFrame: 6-months post-genicular nerve RFA
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
Study officials:
affiliation: University of Utah Orthopaedics
name: Lucas Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References: