Applied Public-Private Research enabling OsteoArthritis Clinical Headway study * a 2-year multicentre, European, exploratory study without therapeutic benefit in patients with knee osteoarthritis to describe, validate, and predict phenotypes of knee osteoarthritis by use of clinical, imaging, and biochemical (bio)markers.

Applied Public-Private Research enabling OsteoArthritis Clinical Headway study * a 2-year multicentre, European, exploratory study without therapeutic benefit in patients with knee osteoarthritis to describe, validate, and predict phenotypes of knee osteoarthritis by use of clinical, imaging, and biochemical (bio)markers. - APPROACH

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48924

Enrollment

210

Registered

2017-09-11

Start date

2018-01-19

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

knee osteoarthritis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Ambulatory (able to walk unassisted) 2. At least 18 years of age 3. Capable of understanding the study 4. Capable of writing and reading in local language 5. 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. 6. Informed consent obtained as described in section 12.3 of the protocol. 7. Highest probability to progress based on a selection algorithm based on the following criteria: - 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

Exclusion criteria

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 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 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. Self-reported severe spine OA

Design outcomes

Primary

Measure	Time frame
Progression of osteoarthritis measured by joint tissue structure based on radiographs, MRI, and biochemical (bio)markers as well as symptoms (pain, function) and quality of life by questionnaires.	—

Secondary

Measure	Time frame
a multitude of (novel and conventional) clinical, maging, and biochemical parameters related to osteoarthritis.	—

Countries

Netherlands

Outcome results