Clinical trial: A 2-year, European Multicentre Study to Describe, Validate, and Predict Phenotypes of Knee Osteoarthritis (NCT03883568)

Eligibility criteria:
Inclusion Criteria:

          1. Informed consent obtained.

          2. Ambulatory (able to walk unassisted)

          3. At least 18 years of age

          4. Capable of understanding the study

          5. Capable of writing and reading in local language

          6. Predominantly tibiofemoral knee osteoarthritis and satisfy the clinical classification
             criteria of the American College of Rheumatology (ACR): Knee pain and three of the
             following criteria: over 50 years age, less than 30 minutes of morning stiffness,
             crepitus on active motion, bony tenderness, bony enlargement, or no palpable warmth.

          7. Highest probability to progress based on the algorithm based on the following
             parameters:

               -  Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

               -  BMI (in recording height and weight)

               -  Pain NRS of the index knee at the moment of the screening visit

               -  Pain NRS of the index knee during the last week before the screening visit

               -  Age

               -  Gender

               -  KIDA parameters of the index knee, based on standardized weight-bearing (KIDA)
                  radiograph, measured < 3 months (patients with a Joint Space Width (JSW) < 2 mm
                  of the index knee will not be included)

             Exclusion Criteria:

          8. Not being able to comply to the protocol

          9. Participating in a trial with local therapeutic intervention for index knee OA
             (pharmaceutical or surgical) or systemic Disease Modifying OsteoArthritic Drugs
             (DMOADs) or potential DMOADs treatments for OA at the same time or within the past 6
             months or anticipated in the forthcoming; participation in non-interventional
             registries or epidemiological studies is allowed.

         10. Surgery of the index knee in the past 6 months (to avoid interferences with imaging)

         11. Scheduled or expected surgery of the index knee in the next 2 years (to avoid
             interferences with imaging)

         12. Pregnancy (child bearing woman) because of imaging (radiation and MRI, risks)

         13. Predominantly patellar femoral knee OA (clinical judgment)

         14. The following secondary osteoarthritis of the knee: clinically significant deformities
             of the lower limbs (varus >10°, valgus >10°), septic arthritis, inflammatory joint
             disease, gout, major chondrocalcinosis (pseudogout), Paget's disease of the bone,
             ochronosis, acromegaly, haemochromatosis, Wilson's disease, rheumatic symptoms due to
             malignancies, primary osteochondromatosis, osteonecrosis, osteochondritis dissecans,
             haemophilia

         15. Generalized pain syndrome, for example fibromyalgia

         16. Patients with contra indication to MRI or CT

         17. Hip replacement or expected hip replacement within 6 months

         18. Osteosynthesis material near the knee joint

         19. Self-reported severe Intervertebral disc (IVD) degeneration or facet OA
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 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment