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Inclusion criteria

Patient has to meet al inclusion criteria to be eligible.

  • Signed written informed consent must be obtained before any study assessment is performed.

  • 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 of screening and,  an average NRS score reported in the patient diary >4 at the end of the run-in period). 

  • Unresponsive (meaning insufficient pain reduction or intolerance) to conventional treatments ongoing for at least 12 months prior to inclusion. Conventional treatments must include all of the following: active physiotherapy, pharmacological treatment of pain and, in case of OA patients, intra-articular infiltration.

  • Only for patients with OA: Radiologic confirmation of knee osteoarthritis of grade 2 (mild), 3 (moderate) or 4 (severe) noted within 12 months prior to the screening for the index knee according to the Kellgren Lawrence criteria diagnosed by an independent radiologist with experience in musculoskeletal imaging on Rx or MRI. If imaging will need to be performed at screening it is recommended to perform an MRI instead of Rx. Imaging with MRI will enable the independent radiologist to perform a better estimation of the grade of OA.

  • Only for patients with PPSP after TKA: need to have had a negative orthopaedic work-up.

Exclusion criteria

Patient cannot meet a single exclusion criterion to be eligible.

  • Local or systemic infection (bacteraemia).

  • Evidence of inflammatory arthritis or an inflammatory systemic disease responsible for knee pain.

  • Intra-articular injections (steroids, hyaluronic acid, platelet enriched plasma, …) in the index knee during the
    3 months prior to the procedure.

  • Pregnant, nursing, or planning to become pregnant before the study intervention. Participants who become pregnant after the study intervention during the follow-up period will not be excluded.

  • Chronic widespread pain e.g., fibromyalgia.

  • Patients with unstable psychosocial disorder. Unstable psychosocial disorder is defined as:

    • any untreated psychiatric conditions

    • any psychiatric condition where the treating medication is not stable the last 3 months prior to inclusion

    • patients currently treated by a psychiatrist and the psychiatrist could not confirm that the psychosocial disorder is stable.

    • Patients treated by a general practitioner are considered to have a stable condition.

  • Allergies to products used during the procedure (lidocaine, propofol, chlorhexidine).

  • Uncontrolled coagulopathy defined as supratherapeutic dose of anticoagulation medication.

  • Uncontrolled immune suppression.

  • Participating in another clinical trial/investigation within 30 days prior to signing informed consent.

  • Patient is currently implanted with a neurostimulator.

  • Current radicular pain in index leg.

  • Previous conventional or cooled radiofrequency of the genicular nerves of the  index knee.

  • Patients with therapy resistant bilateral knee pain defined as patients who fulfil the inclusion criteria for pain in each knee i.e., patients who experience chronic knee pain (> 12 months) in both knees that is moderate to severe (defined as NRS > 4 on most or all days either constantly or with motion) and that is unresponsive (meaning insufficient pain reduction or intolerance) to conventional treatments ongoing for at least 12 months prior to inclusion. Conventional treatments must include all of the following: active physiotherapy, pharmacological treatment of pain and, in case of OA patients, intra-articular infiltration.

  • 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 who are unwilling or mentally incapable to complete the study questionnaires.

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