Estimation of the Localization Accuracy of the Genicular Ablation Procedure Applied for Chronic Pain Suppression

TPM Medical Systems

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Procedure: genicular ablation procedure; Device: MRI

Study type: Interventional

Funder types: Industry

Identifiers

NCT02873611

CL-001-F1

Details and patient eligibility

About

Estimation of the localization accuracy of the genicular ablation procedure applied for chronic pain suppression

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 years and older.
• Diagnosed with primary degenerative osteoarthritis.
• Complaining of knee pains
• Patients clinically eligible for genicular nerve ablation procedure non-electively based on physical examination
• Patient signed ICF

Exclusion criteria

• Co-morbidities: patient suffers from neuropathy, bony tumors, traumatic fractures and DM.
• Claustrophobic or failing cooperativity assessment of laying still during long MRI scans
• Pregnancy or pregnancy suspicion
• Enrolled in concurrent studies that may confound the results of this study
• Clinical condition that in the investigator's opinion would not allow the subject to complete the study, e.g., tremor, extreme obesity, mental disorders.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

MRI scanning and the genicular ablation

Experimental group

Description:

patients undergoing both MRI scanning and the genicular ablation procedure. additional MRI testing of apprx. 0.5-1 hour

Treatment:

Procedure: genicular ablation procedure

Device: MRI