Patients With Knee Pain Caused by Osteoarthritis: Comparison of Conservative Medical Management With RadioFrequency Ablation or Chemical Neurolysis of the Genicular Nerves With Phenol

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 90
Healthy Volunteers: f
View:

• 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 can include: active physiotherapy, pharmacological treatment of pain (acetaminophen or NSAIDs) and intra-articular corticosteroid infiltration.

• Radiologic confirmation of arthritis for the target knee. Defined as the Kellgren Lawrence (KL) score of 2 or more on X-ray or MRI.

Locations
Other Locations
Netherlands
Dijklander Ziekenhuis
RECRUITING
Hoorn
Bravis Ziekenhuis
NOT_YET_RECRUITING
Roosendaal
Contact Information
Primary
Gezina Oei, MD,PhD
g.t.m.l.oei@dijklander.nl
0031229257257
Backup
Aine Honohan, MSc
a.g.honohan@Dijklander.nl
0031646340596
Time Frame
Start Date: 2023-11-27
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 192
Treatments
Active_comparator: Chemical ablation of the genicular nerves with Phenol 6%
Chemical ablation with phenol is done by injection of 1,5ml of phenol 6 % at the superomedial, the superolateral and the inferomedial genicular nerve.
Active_comparator: Radiofrequency ablation (RFA) of the genicular nerves
In our study we will make two RFA lesions at every target with 80°C for 90 seconds with a 5mm active tip. So we will make 6 lesions in total. The targets are the superomedial, the superolateral and the inferomedial genicular nerve.
No_intervention: Conservative treatment
Examples of allowed conservative treatments during the study are patient education, physical therapy, weight loss and different pharmacological treatments.
Related Therapeutic Areas
Sponsors
Collaborators: Bravis Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Leads: Dijklander Ziekenhuis

This content was sourced from clinicaltrials.gov