Total Knee ArthroplastyNCT05130216
Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
An observational study of Total Knee Arthroplasty, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Genicular Nerve Radiofrequency Ablation
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2021to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have high pain following total knee replacement identified in clinic.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
Official title: A Single-arm Pilot Study of 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.
Read the 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
- Total Knee Arthroplasty
- Being tested
- Genicular Nerve Radiofrequency Ablation
- Keywords
- Genicular Nerve Radiofrequency Ablation, Total Knee Arthroplasty, Chronic Knee Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genicular Nerve Radiofrequency AblationOther
Radiofrequency Ablation (RFA)
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Arthroplasty | Patients who have undergone total knee arthroplasty post one-year. Receives: Other: Genicular Nerve Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric ranking scale (NRS) pain
NRS pain score (0 no pain - 10 severe pain)
Measured: Prior to nerve radiofrequency ablation (RFA)
Numeric ranking scale (NRS) pain
NRS pain score (0 no pain - 10 severe pain)
Measured: 1-month post-genicular nerve RFA
Numeric ranking scale (NRS) pain
NRS pain score (0 no pain - 10 severe pain)
Measured: 3-months post-genicular nerve RFA
Numeric ranking scale (NRS) pain
NRS pain score (0 no pain - 10 severe pain)
Measured: 6-months post-genicular nerve RFA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start22 Sep 2021
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucas Anderson, University of Utah
- Investigators
- Lucas Anderson, MD, Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130216
- Sponsor's protocol ID
- 144989
- Status last verified
- Jan 2026
- First submitted
- 10 Nov 2021
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Pilot Study of Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05130216
- Acronym / sponsor ID
- 144989
- Conditions
- Total Knee Arthroplasty
- Keywords
- Genicular Nerve Radiofrequency Ablation, Total Knee Arthroplasty, Chronic Knee Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Knee Arthroplasty | – | Other: Genicular Nerve Radiofrequency AblationPatients who have undergone total knee arthroplasty post one-year. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have high pain following total knee replacement identified in clinic.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genicular Nerve Radiofrequency AblationRadiofrequency Ablation (RFA) | Other | Total Knee Arthroplasty |
Primary outcome
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)
Numeric ranking scale (NRS) pain
Time frame: 6-months post-genicular nerve RFA
NRS pain score (0 no pain - 10 severe pain)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas Anderson, MD principal investigator
University of Utah Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric ranking scale (NRS) pain (time frame: Prior to nerve radiofrequency ablation (RFA)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.