Ambulatory Monitoring of Knee Loading during ADL, towards Personalized Treatment and Rehabilitation Strategies for Knee Osteoarthritis Patients

Recruiting

• Conditions: 10023213; knee osteoarthritis

• Registration Number: NL-OMON36803
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 81

Inclusion Criteria

The subjects have to be standardized by age. Only women between the age of 50 and 65 will be included for this study. The cut-off age of 50 is determined by epidemiological data about prevalence of knee osteoarthritis. In which osteoarthritis is more common in women and in women at an age of >50 years. The age of 65 is set as a cut-off point because the risks of co-morbidity increases severely after the age of 65 and so does the risk of altered mechanics of the lower-limb due to other diseases and/or musculoskeletal or neurological problems. Males are not included because we want to standardize for gender. OA patients with a Kellgren-Lawrence(KL)-knee score of 1 and 2 are included in the OA groups. Obese OA patients will be recruited from the *artrose kliniek maastricht*. The American College of Rheumatology clinical classification criteria are used to define knee OA. This requires the presence of knee pain and at least 3 of the following: age > 50 years, morning stiffness < 30 min, crepitus, bony tenderness, bony enlargement, and no palpable warmth. Subjects with a BMI < 25 will be included in the non-obese group; subjects with a BMI > 30 will be included in the obese group. A normalized knee adduction moment has been shown to be the most sensitive marker for progression of OA (15,16). A total of 81 subjects will be included in the study (27 per group) based on the following assumptions; i) a 2% difference in normalized adduction torque differentiates between subjects prone to progression of OA and those that are not(i.e. a 2% difference in knee adduction moment distinguishes between onset of cartilage degeneration or not, which is clinically represented with pain and movement dysfunction, as suggested by Andriacchi and Muendermann 2004) and ii) a dropout rate of 20%.

Exclusion Criteria

Clinical exclusion criteria: any inflammatory arthritis, trauma, patellofemoral osteoarthritis, ACL-injury, medial and collateral ligament injury;MRI exclusion criteria: knee replacement surgery; weight > 150 kg; knee circumference > 52 cm; claustrophobia. dGEMRIC exclusion criteria: glomerular filtration rate (eGFR) < 60 mmol/l, pregnancy, or breast feeding. These exclusion criteria go for all subjects including our healthy controls.
We consider subjects healthy controls in this study when they are non-obese (BMI<25), have no knee osteoarthritis (according to the American College of Rheumatology classification criteria) and do not meet any of the other exclusion criteria mentioned above.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified