NCT03453372

MRgFUS in the Treatment of Osteoarthritic Knee Pain

Pain in Knee Osteoarthritis, a Placebo-controlled Randomized Clinical Trial for a New Potential Therapeutic Approach: Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A double-blind placebo-controlled randomized clinical trial to evaluate the efficacy of magnetic resonance-guided focused ultrasound surgery (MRgFUS) in the treatment of pain caused by knee osteoarthritis (OA)

Detailed description

Osteoarthritis (OA) is a common, disabling, and costly disease, and the knee is one of the most affected joints. The predominant symptom is pain. Effective and lasting non-invasive treatment approaches are missing. MR-guided focused ultrasound surgery (MRgFUS) is a new minimally invasive technique which may represent a valid solution providing several advantages. The primary aim of this work will be to assess the efficacy of MRgFUS in the treatment of pain caused by knee OA in 80 patients candidate for arthroplasty in a prospective, randomized, double-blinded, placebo-controlled clinical trial. Different parameters related to pain, quality of life, function, and imaging will be collected and analyzed in a 12-month follow-up. The secondary aims will be focused on a) the evaluation of the effects on the joint organ and changes of biological features in response to MRgFUS, and b) the impact of selective ablation of nociceptors on OA pain, based on the analysis of resected joint tissues.

Conditions

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	MRgFUS Treatment	Treatment of pain caused by knee osteoarthritis with high-intensity focused ultrasound
OTHER	Placebo	Procedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used.

Timeline

• Start date: 2018-08-31
• Primary completion: 2019-02-28
• Completion: 2020-01-12
• First posted: 2018-03-05
• Last updated: 2023-05-11

Locations

1 site across 1 country: Italy