Clinical trial: Study of a Steroid Delivery System for Pain Relief Treatment in Patients With Knee Osteoarthritis (NCT02873273)

Eligibility criteria:
Inclusion Criteria

          -  Male or female ≥ 40 years of age at time of consent

          -  Diagnosis of unilateral or bilateral knee osteoarthritis for at least 6 months prior
             to screening with confirmation of osteoarthritis according to the American College of
             Rheumatology Criteria for Classification of Idiopathic Osteoarthritis of the Knee
             (clinical and radiological) based on an X-ray performed within 6 months prior to
             screening or during the screening period

          -  Kellgren - Lawrence grade ≥2 on weight bearing anteroposterior femorotibial radiograph
             performed within 6 months prior to or during screening period

          -  Mean score of ≥ 5 and ≤ 10 on the 24 hour average pain score (0 - 10 Numeric Rating
             System) during the screening period

          -  Body mass index (BMI) ≤ 40 kg/m2

          -  Willingness and ability to comply with the study procedures and visit schedules and
             ability to follow verbal and written instructions

          -  Willingness to stop all pain medications except acetaminophen and paracetamol 14 days
             prior to implantation

        Exclusion Criteria:

          -  Fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic
             conditions which could interfere with the evaluation of the index knee

          -  History of inflammatory arthritis including rheumatoid arthritis, juvenile
             inflammatory arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing
             spondylitis, reactive arthritis

          -  Hemophilia

          -  Achondroplasia

          -  History of infection in the index joint

          -  Intra-articular corticosteroid (investigational or marketed) in any joint within three
             months of screening

          -  Intra-articular hyaluronic acid (investigational or marketed) in the index knee within
             three months of screening

          -  Oral, inhaled, and intranasal corticosteroids (investigational or marketed) within one
             month of screening

          -  Prior arthroscopic or open surgery of the index knee within 12 months of screening

          -  Planned / anticipated surgery of the index knee during the study period

          -  Active or history of malignancy within the last five years, with the exception of
             resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected
             cervical atypia or carcinoma in situ

          -  Insulin dependent diabetes

          -  History of or active Cushing's syndrome

          -  Skin breakdown at index knee where procedure would take place

          -  Women of child-bearing potential

          -  Case history related to motor vehicle accident or workers compensation

          -  Presence of hardware in the index knee (e.g. screws, plates)

          -  Immunocompromised patients (TB, HIV, etc.)

          -  Allergic reactions to acetaminophen and paracetamol
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 99 Years

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