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Clinical Trials/NCT05130216
NCT05130216
Completed
Not Applicable

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

University of Utah1 site in 1 country5 target enrollmentStarted: September 22, 2021Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
5
Locations
1
Primary Endpoint
Numeric ranking scale (NRS) pain

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
30 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Total Knee Arthroplasty

Patients who have undergone total knee arthroplasty post one-year.

Intervention: Genicular Nerve Radiofrequency Ablation (Other)

Outcomes

Primary Outcomes

Numeric ranking scale (NRS) pain

Time Frame: 6-months post-genicular nerve RFA

NRS pain score (0 no pain - 10 severe pain)

Numeric ranking scale (NRS) pain

Time Frame: Prior to nerve radiofrequency ablation (RFA)

NRS pain score (0 no pain - 10 severe pain)

Numeric ranking scale (NRS) pain

Time Frame: 1-month post-genicular nerve RFA

NRS pain score (0 no pain - 10 severe pain)

Numeric ranking scale (NRS) pain

Time Frame: 3-months post-genicular nerve RFA

NRS pain score (0 no pain - 10 severe pain)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lucas Anderson

Principle Investigator

University of Utah

Study Sites (1)

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