Actively Recruiting
RFA or Chemical Neurolysis of the Genicular Nerves Compared to Conservative Treatment for Knee Pain Caused by OA
Led by Dijklander Ziekenhuis · Updated on 2023-12-05
192
Participants Needed
2
Research Sites
152 weeks
Total Duration
On this page
Sponsors
D
Dijklander Ziekenhuis
Lead Sponsor
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
RFA or Chemical Neurolysis of the Genicular Nerves Compared to Conservative Treatment for Knee Pain Caused by OA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged over 35 years of any gender not suitable for total knee replacement due to age, health, or other reasons
- Oxford Knee Score less than 30 on a scale from 0 (severe function) to 48 (good function)
- Moderate to severe knee pain (NRS score 6 or higher) despite at least 3 months of conservative treatment including physical therapy, pain medications, or steroid knee injections
- Radiologic evidence of knee arthritis with Kellgren Lawrence score 2 or higher on X-ray or MRI
You will not qualify if you...
- Previous genicular nerve ablation or partial, resurfacing, or total knee replacement surgery in the affected knee
- History of nerve or blood vessel injury or recent trauma to the lower limbs
- Chronic widespread pain conditions
- Polyneuropathy or nerve root pain in the legs
- Current implant of a neurostimulator device
- Local or systemic infections
- Uncontrolled immune system suppression
- Knee injections with steroids, hyaluronic acid, or other biologics within 90 days
- Arthroscopic knee surgery within 180 days
- Body mass index under 18.5 or insufficient tissue thickness around the knee for safe ablation
- Allergies to lidocaine, phenol, or contrast dye used in procedures
- Planned total knee replacement surgery soon
- Psychosocial issues affecting participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Dijklander Ziekenhuis
Hoorn, North Holland, Netherlands, 1624NP
Actively Recruiting
2
Bravis Ziekenhuis
Roosendaal, Netherlands, 4708AE
Not Yet Recruiting
Research Team
G
Gezina Oei, MD,PhD
CONTACT
A
Aine Honohan, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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