Clinical trial: A Prospective Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device (NCT01704157)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female, 18 years of age and older.

          -  Participants must meet American College of Rheumatology (ACR) criteria for
             osteoarthritis of the knee (unilateral or bilateral). Clinical criteria includes knee
             pain and at least three of the following 6 criteria: 50 years of age or older,
             stiffness lasting less than 30 minutes, crepitus, bony tenderness, bony enlargement,
             and/or no warmth to the touch.

          -  Any medications (prescription and/or over-the counter) must be maintained on a stable
             schedule for ≥ 2 weeks prior to treatment. No washout period is allowed.

          -  An average Visual Analog Scale (VAS) for pain ≥ 4 over the last 30 days.

          -  Subject is willing and able to give written informed consent.

          -  Subject is willing and able to comply with study instructions and commit to all
             follow-up visits for the duration of the study.

          -  Subject is in good general health and free of any systemic disease state or physical
             condition that might impair evaluation or which in the investigator's opinion, exposes
             the subject to an unacceptable risk by study participation.

        Exclusion Criteria:

          -  A partial or full knee replacement (in the treated knee).

          -  Any use of systemic injections (in any area) within the last 6 months.

          -  Current enrollment in an investigational drug or a device study that specifically
             targets pain treatment.

          -  Any additional diagnosis that in the opinion of the investigator may directly
             contribute to knee pain.

          -  Any concomitant inflammatory disease or other condition that affects the joints (e.g.
             rheumatoid arthritis, metabolic bones disease, gout, active infection, etc.).

          -  Any clotting disorder and/or has used an anticoagulant (e.g., warfarin, clopidogrel,
             etc.) within seven (7) days prior to administration of the device.

          -  Allergy or intolerance to lidocaine.

          -  Any local skin condition at the treatment site that in the investigator's opinion
             would adversely affect treatment or outcomes.

          -  Any chronic medical condition that in the investigator's opinion would prevent
             adequate participation.

          -  Any chronic medication use (prescription, over-the-counter, etc.) that in the
             investigator's opinion would affect study participation or subject safety.

          -  For any reason, in the opinion of the investigator, the subject may not be a suitable
             candidate for study participation (i.e., history of noncompliance, drug dependency,
             any related knee injury due to a worker's compensation claim, etc.).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment