Status:
RECRUITING
RFA or Chemical Neurolysis of the Genicular Nerves Compared to Conservative Treatment for Knee Pain Caused by OA
Lead Sponsor:
Dijklander Ziekenhuis
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Bravis Hospital
Conditions:
Osteo Arthritis Knee
Knee Pain Chronic
Eligibility:
All Genders
35-90 years
Phase:
NA
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 conservat...
Detailed Description
In guidelines for knee osteoarthritis (OA), conservative treatments are physical therapy, analgesics and intra-articular injections with corticosteroids. In severe OA and persisting symptomatic cases ...
Eligibility Criteria
Inclusion
- Adult patients of both sexes, \>35 years who are not a candidate for TKA due to young age, old age, comorbidity or technical reasons.
- OKS \< 30 on a scale from 0 (severe function) to 48 points (satisfactory function).
- 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.
- 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
- Patient with prior ablation of the genicular nerves, prior partial, resurfacing, or TKA of the target knee (residual hardware).
- Patient with a history of neurovascular injury or recent trauma of the lower extremities.
- Patient with chronic widespread pain.
- Polyneuropathy and/or radicular pain in the lower extremities.
- Patient is currently implanted with a neurostimulator.
- Local or systemic infection (bacteraemia).
- Uncontrolled immune suppression.
- Intra-articular injections (steroids, hyaluronic acid, platelet enriched plasma, stem cell, …) in the target knee within 90 days from randomisation.
- Arthroscopic debridement/lavage into the target knee within 180 days from randomisation.
- 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).
- Allergies to products used during the procedure (lidocaine, phenol, contrast dye).
- Patients who have a planned TKA in the near future, defined as patients who already have agreed on a date for the TKA procedure.
- Patients with psychosocial problems as determined by the investigator.
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT06094660
Start Date
November 27 2023
End Date
November 1 2026
Last Update
December 5 2023
Active Locations (2)
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1
Dijklander Ziekenhuis
Hoorn, North Holland, Netherlands, 1624NP
2
Bravis Ziekenhuis
Roosendaal, Netherlands, 4708AE