A clinical trial to asses the efficacy on long term pain relief in knee degenerative arthritis by Cooled Radiofrequency Genicular Nerve Ablation Treatment in two different methods

Not Applicable

• Conditions: Health Condition 1: M179- Osteoarthritis of knee, unspecified

• Registration Number: CTRI/2020/08/027442
• Lead Sponsor: Central Hospital Garden Reach South Eastern Railway

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Age >= 40 years to <=80 years

2.Able to understand the informed consent form and provide written informed consent and able to follow up

3.Chronic knee pain for longer than 6 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.)

4.Continued pain in the target knee despite at least 3 months of conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs [NSAIDs])

5.Radiologic confirmation of arthritis (x-ray/MRI/CT) of OA grade of 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee (Kellgren and Lawrence system)

Exclusion Criteria

a.Patient was suffering from advanced systemic disease such as decompensated heart failure, pneumonia, or dementia leaving them too debilitated to participate in follow-up

b.Knee had a mechanical injury (e.g., meniscal tear or tendon damage); and/or

c.The patient was suffering from a chronic rheumatologic disorder. Evidence of inflammatory arthritis (for example, rheumatoid arthritis) or other systemic inflammatory condition (for example, gout, fibromyalgia) that could cause knee pain

d.Evidence of neuropathic pain affecting the index knee

e.Previous or pending lower limb amputation

f.Hyaluronic acid injection, platelet rich plasma (PRP), stem cell, or arthroscopic debridement/lavage injection into the index knee within 90 days.

g.Clinically significant ligamentous laxity of the index knee

h.Clinically significant valgus/varus deformities or evidence of pathology (other than osteoarthritis of knee) that materially affects gait or function of the knee or is the underlying cause of the knee pain and/or functional limitations

i.Pregnant, nursing or intent on becoming pregnant during the study period

j.Allergies to any of the medications to be used during the procedures, including known hypersensitivity (allergy) to hyaluronate preparations or allergies to avian or avian-derived products (including eggs, feathers, or poultry)

k.Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.)

l.Subject currently implanted with pacemaker, stimulator, or defibrillator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified