Last updated: December 4, 2023
Sponsor: Dijklander Ziekenhuis
Overall Status: Active - Recruiting
Phase
N/A
Condition
Osteoarthritis
Treatment
Genicular nerve block with Phenol 6%
Diagnostic genicular nerve block
Genicular nerve block with Radiofrequency Ablation (RFA)
Clinical Study ID
NCT06094660
DOC 045
Ages 35-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adult patients of both sexes, >35 years who are not a candidate for TKA due to youngage, old age, comorbidity or technical reasons.
- OKS < 30 on a scale from 0 (severe function) to 48 points (satisfactory function).
- 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 ofconservative treatments. Conservative treatment can include: active physiotherapy,pharmacological treatment of pain (acetaminophen or NSAIDs) and intra-articularcorticosteroid infiltration.
- Radiologic confirmation of arthritis for the target knee. Defined as the KellgrenLawrence (KL) score of 2 or more on X-ray or MRI.
Exclusion
Exclusion Criteria:
- Patient with prior ablation of the genicular nerves, prior partial, resurfacing, orTKA of the target knee (residual hardware).
- Patient with a history of neurovascular injury or recent trauma of the lowerextremities.
- Patient with chronic widespread pain.
- Polyneuropathy and/or radicular pain in the lower extremities.
- Patient is currently implanted with a neurostimulator.
- Local or systemic infection (bacteraemia).
- Uncontrolled immune suppression.
- Intra-articular injections (steroids, hyaluronic acid, platelet enriched plasma, stemcell, …) in the target knee within 90 days from randomisation.
- Arthroscopic debridement/lavage into the target knee within 180 days fromrandomisation.
- BMI<18,5 kg/m2 and patients with minimal subcutaneous tissue thickness that would notaccommodate ablation with phenol or radio frequency (risk of skin burns).
- Allergies to products used during the procedure (lidocaine, phenol, contrast dye).
- Patients who have a planned TKA in the near future, defined as patients who alreadyhave agreed on a date for the TKA procedure.
- Patients with psychosocial problems as determined by the investigator.
Study Design
Total Participants: 192
Treatment Group(s): 3
Primary Treatment: Genicular nerve block with Phenol 6%
Phase:
Study Start date:
November 27, 2023
Estimated Completion Date:
November 01, 2026
Study Description
Connect with a study center
Dijklander Ziekenhuis
Hoorn, Noord-Holland 1624NP
NetherlandsActive - Recruiting
Bravis Ziekenhuis
Roosendaal, 4708AE
NetherlandsSite Not Available
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