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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 192

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
function).
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.

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
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter, the OKS (Oxford Knee Score) will be collected at<br /><br>baseline, and at 6 weeks, 3 months, 6 months and 12 months after the<br /><br>intervention.<br /><br><br /><br>The OKS is scored in different ways. We will use the 0 to 48 system which is<br /><br>considered the best. In this system each question is scored between 0 and 4,<br /><br>with 4 being the best outcome. This produces overall scores from 0 to 48, with<br /><br>48 being the best outcome and a lower score indicates more functional<br /><br>limitations and pain. </p><br>

Secondary Outcome Measures