Skip to content

Stability of the Journey II XR total knee system, measured with RSA

Stability of the Journey II XR total knee system, measured with RSA - Journey II XR

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50159
Enrollment
50
Registered
2020-03-26
Start date
2021-11-27
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

degenerative joint disease Knee osteoarthritis

Interventions

None listed

Sponsors

Sint Maartenskliniek
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients: Age between 40-80 years old Non-inflammatory knee osteoarthritis, confirmed by radiology Set to receive a primary total knee arthroplasty Stable health Intact anterior and posterior cruciate ligaments Healthy controls: 40-80 years old In stable health

Exclusion criteria

Exclusion criteria: Patients: Patient has BMI > 35 Patient has an active, local infection or systemic infection Operation to the study knee Healthy controls: Moderate to severe pain in one or both knees, hip or ankle (>4 on items 3-6 form Brief Pain Inventory) Previous replacement surgery to knee, hip or ankle or planned for future replacement surgery

Design outcomes

Primary

MeasureTime frame
The main study parameters are the 3D translation (in mm) and rotation (in degrees) of the components of the Journey II XR over time, in reference to the (markers in the) bone.

Secondary

MeasureTime frame
The secondary study parameters are the contact point of the femur on tibia in 90 degrees flexion and extension, gait speed and quantity measured at home using wearable sensors, knee joint kinematics and moments during walking tasks in the lab with and without perturbations and CROMs/PROMs and additional questionnaires.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026