NCT06094660 RFA or Chemical Neurolysis of the Genicular Nerves Compared to Conservative Treatment for Knee Pain Caused by OA
| NCT ID | NCT06094660 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dijklander Ziekenhuis |
| Condition | Osteo Arthritis Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 192 participants in total. It began in 2023-11-27 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A randomised controlled triall (RCT) with three parallel arms comparing the functional outcome of chemical ablation with phenol and radiofrequency ablation (RFA) of the genicular nerves with conservative treatment in patients with chronic knee pain caused by osteoarthritis (OA).
Eligibility Criteria
Inclusion Criteria: 1. Adult patients of both sexes, \>35 years who are not a candidate for TKA due to young age, old age, comorbidity or technical reasons. 2. OKS \< 30 on a scale from 0 (severe function) to 48 points (satisfactory function). 3. Continued pain in the target knee that is moderate to severe (defined as NRS ≥ 6 on an 11-point NRS scale) either constantly or with motion despite at least 3 months of conservative treatments. Conservative treatment can include: active physiotherapy, pharmacological treatment of pain (acetaminophen or NSAIDs) and intra-articular corticosteroid infiltration. 4. Radiologic confirmation of arthritis for the target knee. Defined as the Kellgren Lawrence (KL) score of 2 or more on X-ray or MRI. Exclusion Criteria: 1. Patient with prior ablation of the genicular nerves, prior partial, resurfacing, or TKA of the target knee (residual hardware). 2. Patient with a history of neurovascular injury or recent trauma of the lower extremities. 3. Patient with chronic widespread pain. 4. Polyneuropathy and/or radicular pain in the lower extremities. 5. Patient is currently implanted with a neurostimulator. 6. Local or systemic infection (bacteraemia). 7. Uncontrolled immune suppression. 8. Intra-articular injections (steroids, hyaluronic acid, platelet enriched plasma, stem cell, …) in the target knee within 90 days from randomisation. 9. Arthroscopic debridement/lavage into the target knee within 180 days from randomisation. 10. BMI\<18,5 kg/m2 and patients with minimal subcutaneous tissue thickness that would not accommodate ablation with phenol or radio frequency (risk of skin burns). 11. Allergies to products used during the procedure (lidocaine, phenol, contrast dye). 12. Patients who have a planned TKA in the near future, defined as patients who already have agreed on a date for the TKA procedure. 13. Patients with psychosocial problems as determined by the investigator.
Contact & Investigator
Gezina Oei, MD, PhD
PRINCIPAL INVESTIGATOR
Academic Medical Centre Amsterdam
Frequently Asked Questions
Who can join the NCT06094660 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 90 Years, studying Osteo Arthritis Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06094660 currently recruiting?
Yes, NCT06094660 is actively recruiting participants. Contact the research team at g.t.m.l.oei@dijklander.nl for enrollment information.
Where is the NCT06094660 trial being conducted?
This trial is being conducted at Hoorn, Netherlands, Roosendaal, Netherlands.
Who is sponsoring the NCT06094660 clinical trial?
NCT06094660 is sponsored by Dijklander Ziekenhuis. The principal investigator is Gezina Oei, MD, PhD at Academic Medical Centre Amsterdam. The trial plans to enroll 192 participants.