MRgFUS in the Treatment of Osteoarthritic Knee Pain

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453372
• Other study ID #: knee@IORFus
• Status: Completed
• Phase: N/A
• Start date: August 31, 2018
• Est. completion date: January 12, 2020

Study information

• Verified date: March 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 12, 2020
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male and female aged 50-80 years

• Activity-related joint pain

• Patients who have not responded to previous treatments and patients candidate for surgery

• Kellgren-Lawrence score 2-4 on X-rays

• Patients able to give their informed consent

Exclusion Criteria:

• Prior surgery in the past 12 months or previous local treatment in the past 3 months

• Changes in medications used during the previous 2 months

• Corticosteroid use for more than 3 months within the preceding year

• Rheumatologic and neurological disorders

• Fibromyalgia

• Trauma, fracture or osteomyelitis of the investigated joints within the preceding year

• Pregnancy

• Patients with large scars potentially included in the ultrasound beam path

• General contraindications to MRI and/or to anaesthesiological procedures

• Presence of internal hardware or device potentially affecting MR thermometry

• Patients involved in other clinical studies

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of MRgFUS in the treatment of pain caused by knee OA	The efficacy of MRgFUS will be demonstrated if the treatment group has a mean reduction of Visual Analog Pain Scale (VAS) of at least 1.5 points greater than the control group.	Baseline (Day 1), 24 hours post MRgFUS, Week 1, 2, 3, Month 1, 3, 6,12
Secondary	Effects of MRgFUS on the joint organ: inflammation	Enzyme linked immuno assays kits will be used to test inflammatory markers in serum. The reference standard values of the standardized markers will be considered for the evaluations.	Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Secondary	Effects of MRgFUS on the joint organ: bone turnover	Enzyme linked immuno assays kits will be used to test bone turnover markers in serum. The reference standard values of the standardized markers will be considered for the evaluations.	Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Secondary	Effects of MRgFUS on the joint organ: pain	Enzyme linked immuno assays kits will be used to test pain markers in serum. The reference standard values of the standardized markers will be considered for the evaluations.	Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12
Secondary	Effects of MRgFUS on the joint organ: cartilage turnover	Enzyme linked immuno assays kits will be used to test cartilage turnover markers in urine. The reference standard values of the standardized markers will be considered for the evaluations.	Baseline (Day 1), 24 hours post MRgFUS, Month 1, 3, 6,12