RecruitingNot ApplicableNCT06094660

RFA or Chemical Neurolysis of the Genicular Nerves Compared to Conservative Treatment for Knee Pain Caused by OA

Patients With Knee Pain Caused by Osteoarthritis: Comparison of Conservative Medical Management With RadioFrequency Ablation or Chemical Neurolysis of the Genicular Nerves With Phenol

Sponsor

Dijklander Ziekenhuis

Enrollment

192 participants

Start Date

Nov 27, 2023

Study Type

INTERVENTIONAL

Conditions

Osteo Arthritis Knee Knee Pain Chronic

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

Min Age: 35 YearsMax Age: 90 Years

Inclusion Criteria4

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 Criteria13

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.

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Interventions

PROCEDUREDiagnostic genicular nerve block

Diagnostic block will be done with 1,5ml of Lidocaine 2% at the 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve.

PROCEDUREGenicular nerve block with Radiofrequency Ablation (RFA)

Genicular nerve block with RFA will be performed at 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve. Radiofrequency ablation (RFA) is performed by creating two RFA lesions at the 3 treatment sites (6 lesions in total) after local anesthesia with 1,5ml lidocaine 2%. The lesions are made by heating the 5mm active tip of the needle to 80°C for 90 seconds.

PROCEDUREGenicular nerve block with Phenol 6%

Genicular nerve block with Phenol 6% will be performed at 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve. Chemical ablation with phenol is done by injection of 1 ,5ml of phenol 6 % at the 3 target sites after infiltration with contrast dye to rule out intravascular injection. Because infiltration with phenol is painless, prior infiltration of the target site with al local anaesthetic is not necessary.