COPD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are over 18 years of age
• People who have had ongoing, function-limiting knee pain from osteoarthritis for at least three months, with a pain score above 6 out of 10 on a specific pain scale, whether or not they have had previous knee surgeries
• People who have been diagnosed with a moderate level of knee osteoarthritis (called Kellgren-Lawrence Grade II or III), confirmed by an X-ray taken within the last year
• People whose doctor has assessed them as a suitable candidate for the procedure, including those who have already had a total knee replacement
• People who are able to understand the study and are willing to give written consent to take part
• People who are able to follow the study procedures and attend all required follow-up appointments at the trial centre
• People who have tried at least two less invasive treatments without lasting success, such as physical therapy, steroid injections into the joint, or anti-inflammatory medications taken by mouth
• People who have not had certain knee procedures within specific timeframes before signing the consent form: no steroid injection within the past 2 weeks, and no radiofrequency treatment, cryoablation, or hyaluronic acid injection within the past 4 weeks
• People who experienced good but only short-term pain relief (more than 75% relief for at least 2 hours) from a local anaesthetic nerve block injection near the knee
• People who have been assessed by a clinical psychologist and considered psychologically and socially appropriate for an implanted device therapy

Who may not be able to join:

• People with significant pain in the opposite knee that limits their activity, scoring above 6 on a specific pain scale
• People whose hip or foot pain is worse than their knee pain
• People with nerve-related or circulation-related leg pain that causes difficulty walking (confirm with trial site)
• People diagnosed with a severe level of knee osteoarthritis (Kellgren-Lawrence Grade IV), confirmed by an X-ray taken within the last year
• People with major depression or other psychiatric conditions that are not well managed
• People with serious uncontrolled medical conditions, including blood clotting disorders, kidney problems, chronic liver disease, worsening nerve conditions, active infection, unstable chest pain, or severe lung disease
• People with long-term serious conditions that could make it difficult to accurately measure pain and physical function outcomes, such as rheumatoid arthritis, severe spinal narrowing, or heart disease that limits activity
• People who are pregnant, planning to become pregnant, or currently breastfeeding
• People with a Body Mass Index (BMI) over 40
• People with multiple overlapping pain conditions affecting the knee, foot, or ankle, or nerve-related pain that would make it difficult to clearly assess results
• People whose anatomy has been assessed by a doctor as unsuitable for the procedure
• People with lymphoedema, leg ulcers, or other conditions that could affect healing at the procedure site
• People who have had a previous bad reaction to local anaesthetic medications
• People who are workers' compensation claimants
• People who are incarcerated or wearing an ankle monitoring device
• People with a known allergy to the materials used in the device
• People with known or suspected substance abuse within the last two years
• People who have a pacemaker or an implanted heart defibrillator
• People currently participating in another clinical study that could affect the results of this trial
• People for whom the investigator has identified legal or medical concerns that could affect their participation or the reliability of results
• People who already have another active implanted medical device in the same area of the body

Important: Always verify eligibility with the trial site directly before applying.