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

Ambulatory Monitoring of Knee Loading during ADL, towards Personalized Treatment and Rehabilitation Strategies for Knee Osteoarthritis Patients - Ambulatory monitoring of knee loading in knee osteoarthritis during ADL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36803
Enrollment
81
Registered
2011-04-21
Start date
2011-06-01
Completion date
Unknown
Last updated
2024-05-06

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

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 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

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)

Design outcomes

Primary

MeasureTime frame
The pathomechanics and initiation of OA will be conducted in this cross-sectional study. Also the association between obesity and OA will be examined, which will further unravel the pathomechanics of knee osteoarthritis. Our study parameters are: - Lower extremity biomechanics (e.g. knee adduction moment) and knee joint loading will be measured under controlled laboratory conditions using 3D motion analysis (VICON) and surface EMG [15, 16]. - Knee extensor and flexor strength will be assessed with Biodex dynamometer. - Biomarkers for cartilage metabolism (i.e. C2C, CTX-II) will be analyzed using enzyme-linked immunosorbent assay (ELISA) on urine samples obtained on the same day we perform the 3D-motion analysis (VICON) and MRI. [7, 14, 17]. - Structural adaptations of cartilage will be analyzed by using quantitative magnetic resonance imaging [18-20]. Cartilage thickness shall be graded in the anterior, central, and posterior regions of the medial and lateral knee compartments. - Activities of daily life (ADL) and knee flexion and extension in the sagittal plane of the knee will be monitored for a single day follow-up study in which subjects are asked to wear an intelligent knee brace for at least 8 hours per day [21] and a CAM activity monitor for 7 days [22]. The endpoints of the study are described above. Our main endpoint is the knee adduction moment. Our endpoints are: - 3D-motion analysis: Knee adduction moment. This will be our main endpoint! - Biomarkers: Urine samples; ELISA (C2C, CTX-II): inter-group differences - MRI: cartilage thickness graded by region, mentioned above. - Ambulatory knee brace: ADL and flexion/extension in the sagittal plane. - CAM: Activity monitor, Activity pattern for 7 consecutive days.

Secondary

MeasureTime frame
nvt

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)