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Revised Targets for Knee Radiofrequency Ablation

NCT06934421 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-04-24

No results posted yet for this study

Summary

This research team is doing a study to learn more about a new way to treat long-term knee pain caused by joint damage. They are using a treatment called radiofrequency ablation (RFA). This is a procedure where doctors use heat to stop certain nerves from sending pain signals.

In this study, doctors will use ultrasound to guide a small needle to nerves around the knee, called genicular nerves. Then, they will apply heat to those nerves using radiofrequency energy to help reduce pain.

The team created this new method based on recent studies of knee anatomy. They want to find out if this method can safely reduce pain and help people with knee joint damage move better. The study includes people who have moderate to severe knee damage and still have pain after trying medicine, physical therapy, or joint injections.

Each person in the study will have the treatment once. The research team will follow each person for two years. During this time, people in the study will answer simple questions about their knee pain and how it affects their daily life. The researchers will collect this information before the treatment and several times after it. One week after the procedure, the team will call each person to ask how they are feeling and check for any side effects.

Possible benefits of the study include less knee pain and easier movement. Possible risks include pain during the procedure, bruising, swelling, or short-term worsening of pain. Rare risks include nerve problems, weakness, bone damage, or allergic reaction.

The study is free for participants, and there is no payment. Taking part is voluntary. Anyone can stop being in the study at any time without affecting their medical care. The research team will keep all personal information private and secure.

Conditions

  • Osteoarthritis Knee Pain

Interventions

DEVICE

Ultrasound-Guided Genicular Nerve Radiofrequency Ablation

This intervention involves a single-session ultrasound-guided thermal radiofrequency ablation of the superomedial, superolateral, and inferomedial genicular nerves in patients with moderate to severe knee osteoarthritis. Target points follow anatomical references described by Fonkoue et al. and validated in cadaveric studies, differing from classical approaches. Under ultrasound guidance, monopolar RF cannulas are placed, with sensory and motor stimulation confirming accurate positioning. Local anesthesia (2% lidocaine) is applied. Lesions are performed at 85°C for 90 seconds per site. The radiofrequency generator used is CE-marked for pain procedures. The study evaluates a novel targeting protocol, not the safety or effectiveness of the device itself. No fluoroscopy is used. The procedure is performed once. Participants are followed for two years to assess outcomes.

Sponsors & Collaborators

  • Centro Hospitalar Universitario do Algarve

    lead OTHER

Principal Investigators

  • Manuel Tomás Farinha Caroço, Medical Doctor · Unidade Local de Saude do Algarve / Centro Hospitalar Universitario Algarve

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-20
Primary Completion
2028-07-14
Completion
2031-07-30

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06934421 on ClinicalTrials.gov