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NCT Number: NCT05130216

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.

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Key information

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genicular Nerve Radiofrequency Ablation

Other

Radiofrequency Ablation (RFA)

Primary outcomes

  1. Numeric ranking scale (NRS) pain

    Time frame: Prior to nerve radiofrequency ablation (RFA)

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

  2. Numeric ranking scale (NRS) pain

    Time frame: 1-month post-genicular nerve RFA

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

  3. Numeric ranking scale (NRS) pain

    Time frame: 3-months post-genicular nerve RFA

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

  4. Numeric ranking scale (NRS) pain

    Time frame: 6-months post-genicular nerve RFA

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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 23, 2021
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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