Clinical trial: APSS-33-00: A Multicenter, Pilot Study of Autologous Protein Solution (APS) in Knee Osteoarthritis (OA) (NCT02138890)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female ≥40 years and ≤75 years.

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

          -  Diagnosis of knee osteoarthritis (OA) Grade 2 or 3 according to the Kellgren-Lawrence
             scale

          -  Body mass index (BMI) ≤ 40.

          -  Failed at least 1 conservative OA therapy

          -  Signed an independent ethics committee (IEC) approved informed consent form (ICF).

        Main Exclusion Criteria:

          -  Intra-articular Hyaluronic (HA) injection within 6 months- On Day 1 (pre-injection),
             presence of active infection or abnormal effusion in the knee as noted by a physical
             examination (e.g., erythema, redness, heat, swelling).

          -  Presence of symptomatic OA in the non-study knee.

          -  Diagnosed with rheumatoid arthritis (RA), Reiter's syndrome, psoriatic arthritis,
             ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory
             diseases (e.g., inflammatory bowel disease [IBD], sarcoidosis, or amyloidosis) or of
             metabolic origin.

          -  Diagnosis of isolated patella-femoral joint osteoarthritis.

          -  Valgus/varus deformity judged by the investigator to be clinically significant.

          -  Disease of spine, hip or other lower extremity joints of sufficient degree to affect
             assessment of the signal knee. Patients with TKR at the contra-lateral knee or THR in
             either hip may be enrolled provided sufficient pain relief after TKR or THR which does
             not require additional analgesic relief.

          -  Untreated acute traumatic injury of the index knee.

          -  Presence of a symptomatic meniscal tear in the index knee

          -  Limited daily activity for reasons other than OA.

          -  Presence of surgical hardware or other foreign body in the index knee.
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 75 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