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RecruitingNCT06094660

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

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Trial Parameters

ConditionOsteo Arthritis Knee
SponsorDijklander Ziekenhuis
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment192
SexALL
Min Age35 Years
Max Age90 Years
Start Date2023-11-27
Completion2026-11-01
Interventions
Diagnostic genicular nerve blockGenicular nerve block with Radiofrequency Ablation (RFA)Genicular nerve block with Phenol 6%

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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 wi

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