Patients with knee pain caused by osteoarthritis: Comparison of conservative Medical Management with RadioFrequency ablation or chemical neurolysis of the genicular nerves with Phenol. - RADIOPHENO

Amsterdam UMC0 个研究点目标入组 192 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•1.Adult patients of both sexes, older then 35 years who are not a candidate for
•TKA (total knee arthroplasty) due to young age, old age, comorbidity or
•technical reasons.
•2.OKS under 30 on a scale from 0 (severe function) to 48 points (satisfactory
•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.

•1. Patient with prior ablation of the genicular nerves, prior partial,
•resurfacing, or total knee arthroplasty of the target knee (residual hardware).
•2. Patient with a history of neurovascular injury or recent trauma of the lower
•extremities. 3. Patient with chronic widespread pain. 4. Polyneuropathy and/or
•radicular pain in the lower extremities. 5. Patient is currently implanted with
•a neurostimulator. 6. Local or systemic infection (bacteraemia). 7.
•Uncontrolled immune suppression. 8. Intra-articular injections (steroids,
•hyaluronic acid, platelet enriched plasma, stem cell, *) in the target knee
•within 90 days from randomisation. 9. Arthroscopic debridement/lavage into the
•target knee within 180 days from randomisation. 10. 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). 11. Allergies to products
•used during the procedure (lidocaine, phenol, contrast dye). 12. Patients who
•have a planned TKA in the near future, defined as patients who already have
•agreed on a date for the TKA procedure. 13. Patients with psychosocial problems
•as determined by the investigator. 14. Patients who are not able to perform the
•performance based tests as determined by the investigator.

发起方

Amsterdam UMC