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Compares treatment options for Osteo Arthritis Knee
Official title RFA or Chemical Neurolysis of the Genicular Nerves Compared to Conservative Treatment for Knee Pain Caused by OA
ClinicalTrials.gov ID: NCT06094660
What this study is testing
- What it's testing
- A randomised controlled triall (RCT) with three parallel arms comparing the functional outcome of chemical ablation with phenol and radiofrequency ablation (RFA) of the genicular nerves with conservative treatment in patients with chronic knee pain caused by osteoarthritis (OA).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 90
You may be able to join if
- Adult patients of both sexes, \>35 years who are not a candidate for TKA due to young age, 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...
- Radiologic confirmation of arthritis for the target knee. Defined as the Kellgren Lawrence (KL) score of 2 or more on X-ray or MRI.
You likely can't join if
- Patient with prior ablation of the genicular nerves, prior partial, resurfacing, or TKA of the target knee (residual hardware).
- Patient with a history of neurovascular injury or recent trauma of the lower extremities.
- 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).
See the full eligibility criteria
- Adult patients of both sexes, \>35 years who are not a candidate for TKA due to young age, 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 of conservative treatments. Conservative treatment...
- Radiologic confirmation of arthritis for the target knee. Defined as the Kellgren Lawrence (KL) score of 2 or more on X-ray or MRI.
- Patient with prior ablation of the genicular nerves, prior partial, resurfacing, or TKA of the target knee (residual hardware).
- Patient with a history of neurovascular injury or recent trauma of the lower extremities.
- 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, stem cell, …) in the target knee within 90 days from randomisation.
- Arthroscopic debridement/lavage into the target knee within 180 days from randomisation.
- 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).
- 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 already have agreed on a date for the TKA procedure.
- Patients with psychosocial problems as determined by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Hoorn, North Holland, Netherlands
- Roosendaal, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hoorn, North Holland, Netherlands; Roosendaal, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.