Knee osteoarthritis
Conditions
Interventions
All patients will receive usual care by their GP following the NHG guideline
non-traumatic knee complaints. This includes advice for regular physical
activity (at least 30 minutes a day) and advice
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: o First presentation at GP of knee complaints within previous 24 months o Aged between 45 and 70 years o NICE guideline diagnosis of clinical knee OA (i.e. aged 45 or over and activity related joint pain and either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes) o Presence of overweight or obesity (BMI >=25 kg/m2)
Exclusion criteria
Exclusion criteria: o Other pathological conditions that could explain the joint complaints like traumatic onset knee complaints or presence of other forms of arthritis (rheumatoid arthritis, psoriatic arthritis) or pre-patellar bursitis or patellar tendinitis o Any lower extremity condition other than knee OA resulting in physical impairment that will limit GLI participation. o Contraindications for MRI o Previously participated in a GLI. o Inability to understand the Dutch language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5kg or 5% weight reduction after 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints 1. Clinical progression of knee OA: decrease in monthly mean pain intensity (11-point NRS) over last 12-months of follow-up 2. Structural progression of knee OA on MRI after 24 months, using our recently introduced definitions for longitudinal evaluation of OA MRI features For cost-effectiveness: 1. Societal costs over 24 months, using the medical consumption and productivity cost questionnaire (Medical Consumption Questionnaire (iMCQ) and iPCQ questionnaires). 2. Quality of life after 24 months (EQ-5D-5L) Other study parameters 1. Other disease specific PROMS (subscales KOOS questionnaire, PASS, GROC) 2. Other health outcomes including HbA1c level (mmol/L), cholesterol (mmol/L), blood pressure, and intestinal microbiota after 24 month follow-up 3. Psychosocial health outcomes in terms of kinesiophobia and self-efficacy for exercise Qualitative interviews 4. (Gender- and sex-specific) Barriers and facilitators of patients for the implementation of the GLI for patients with KOA. Primary mediators that will be investigated on structural and clinical progression of knee OA: - Change in BMI during the first 18-months of follow-up - Meniscal extrusion using two-dimensional quantitative measurements - Biomarkers - Inflammatory markers including IL-6 and CRP - Effusion, using MOAKS scoring[23], on MRI | — |
Countries
Netherlands
Outcome results
None listed