Standard Versus Novel RFA for Chronic Knee Pain in Osteoarthritis
- Sponsor
- Lawson Research Institute of St. Joseph's
- Study ID
- NCT07674082
- Status
- Not Yet Recruiting
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Conditions
- Osteoarthritis, Knee
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Radiofrequency ablation - 3-target technique — PROCEDUREX-ray imaging is used to guide needles that target the superior lateral, superior medial, and inferior medial genicular nerves surrounding the knee, heat is used to ablate the nerves.
- Radiofrequency ablation - 6-target technique — PROCEDUREX-ray imaging is used to guide needle placement for radiofrequency ablation targeting the superior lateral, superior medial, and inferior medial genicular nerve regions around the knee. The 6-target protocol also includes supplementary ablation lesions at three additional target sites around the knee. These additional targets are treated by adjusting the needle angle once inserted, without requiring additional needle insertions beyond the standard approach.
Study Details
Brief Summary The goal of this pilot study is to evaluate the feasibility and safety of conducting a randomized comparison of two standard-of-care knee radiofrequency ablation (RFA) techniques in adults with chronic knee pain related to knee osteoarthritis. Participants who are already scheduled to receive knee RFA as part of their standard clinical care will be randomized to receive either a standard 3-target (standard) RFA protocol or a 6-target (novel) RFA protocol. The main purpose of this pilot study is to determine whether a future larger randomized trial comparing these two RFA approaches is feasible and safe to conduct. Participants will complete questionnaires about pain, knee function, and stiffness at baseline and at follow-up timepoints for up to 12 months after the RFA procedure. Preliminary pain relief outcomes will also be explored to help inform the design of a future definitive trial. Participants already scheduled for a knee RFA procedure as part of their standard of care for pain related to knee osteoarthritis will answer online survey questions about their pain for up to 12 months.
Key Dates
- First listed
- Jun 29, 2026
- Start date
- Jul 20, 2026
- Status verified
- Jul 2026
- Primary completion
- Aug 20, 2028
- Completion
- Aug 20, 2029
Study Design
- Enrollment
- 24 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Traditional RFAParticipants randomized to this arm will receive the standard 3-target knee RFA protocol as part of their standard clinical care.
- Active Comparator: Novel RFAParticipants randomized to this arm will receive the 6-target knee RFA protocol as part of their standard clinical care.
Primary Outcome Measure
Nature of adverse events [ Time Frame: up to 12 months ]
Central Contacts
- Melissa Calleja, MSc519-646-6100
- Arden Lawson, MSc519-646-6100
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