NCT05130216

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

November 10, 2021

Last Update Submit

January 7, 2026

Conditions

Keywords

Genicular Nerve Radiofrequency AblationTotal Knee ArthroplastyChronic Knee Pain

Outcome Measures

Primary Outcomes (4)

  • Numeric ranking scale (NRS) pain

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

    Prior to nerve radiofrequency ablation (RFA)

  • Numeric ranking scale (NRS) pain

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

    1-month post-genicular nerve RFA

  • Numeric ranking scale (NRS) pain

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

    3-months post-genicular nerve RFA

  • Numeric ranking scale (NRS) pain

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

    6-months post-genicular nerve RFA

Study Arms (1)

Total Knee Arthroplasty

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

Other: Genicular Nerve Radiofrequency Ablation

Interventions

Radiofrequency Ablation (RFA)

Total Knee Arthroplasty

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have high pain following total knee replacement identified in clinic.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

Study Officials

  • Lucas Anderson, MD

    University of Utah Orthopaedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 10, 2021

First Posted

November 23, 2021

Study Start

September 22, 2021

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations