NL-OMON53980
Recruiting
Not Applicable
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 sites192 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Amsterdam UMC
- Enrollment
- 192
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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