Comparison of Conventional and Cooled Radiofrequency of the Genicular Nerves in Patients With Chronic Knee Pain

Inclusion Criteria:

• Signed written informed consent must be obtained before any study assessment isperformed.
• Adult patients (Age ≥ 18 years old).
• Chronic anterior knee pain (> 12 months) that is moderate to severe (defined as NRS > 4 on most or all days for the index knee either constantly or with motion at time ofscreening and, an average NRS score reported in the patient diary >4 at the end of therun-in period).
• Unresponsive (meaning insufficient pain reduction or intolerance) to conventionaltreatments ongoing for at least 12 months prior to inclusion. Conventional treatmentsmust include all of the following: active physiotherapy, pharmacological treatment ofpain and intra-articular corticosteroid infiltration.
• Only for patients with Osteoarthritis (OA): Radiologic confirmation of kneeosteoarthritis of grade 2 (mild), 3 (moderate) or 4 (severe) noted within 12 monthsprior to the screening for the index knee according the Kellgren Lawrence criteriadiagnosed by an independent radiologist with experience in musculoskeletal imaging onradiography (Rx) or magnetic resonance imaging (MRI). If imaging will need to beperformed at screening it is recommended to perform an MRI instead of Rx. Imaging withMRI will enable the independent radiologist to perform a better estimation of thegrade of OA.
• Only for patients with Persistent Post-Surgical Pain (PPSP) after Total KneeArthroplasty (TKA): Patients with PPSP* after TKA need to have had a negativeorthopaedic work-up

Exclusion Criteria:

• Local or systemic infection (bacteraemia).
• Evidence of inflammatory arthritis or an inflammatory systemic disease responsible forknee pain.
• Intra-articular injections (steroids, hyaluronic acid, platelet enriched plasma, ...)in the index knee during the 3 months prior to procedure.
• Pregnant, nursing or planning to become pregnant before the study intervention.Participants who become pregnant after the study intervention during the follow-upperiod will not be excluded.
• Chronic widespread pain.
• Patients with unstable psychosocial disorder.
• Allergies to products used during the procedure (lidocaine, propofol, chlorhexidine).
• Uncontrolled coagulopathy defined as supratherapeutic dose of anticoagulationmedication.
• Uncontrolled immune suppression.
• Participating in another clinical trial/investigation within 30 days prior to signinginformed consent.
• Patient is currently implanted with a neurostimulator.
• Current radicular pain in index leg.
• Previous conventional or cooled radiofrequency of the index knee.
• Patients with bilateral knee pain defined as chronic knee pain (> 12 months) in bothknees that is moderate to severe (defined as a numeric rating scale (NRS) > 4 on mostor all days either constantly or with motion) and that is unresponsive (meaninginsufficient pain reduction or intolerance) to conventional treatments ongoing for atleast 12 months prior to inclusion. Conventional treatments must include all of thefollowing: active physiotherapy, pharmacological treatment of pain and intra-articularcorticosteroid infiltration.
• Patients who have a planned TKA in the near future defined as patients who alreadyhave agreed on a date for the TKA procedure.
• Patients who are unwilling or mentally incapable to complete the study questionnaires.