Differences in diagnosis between weight-bearing and non-weight-bearing conditions in low-field MRI (0.25T) for the diagnosis of patients with instability, patellofemoral problems and component loosening after primary total knee arthroplasty: a feasibility study.

Differences in diagnosis between weight-bearing and non-weight-bearing conditions in low-field MRI (0.25T) for the diagnosis of patients with instability, patellofemoral problems and component loosening after primary total knee arthroplasty: a feasibility study. - Diagnostic value weight-bearing low-field MRI after TKA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46504

Enrollment

Registered

2018-03-29

Start date

2018-06-25

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Problematic total kneeprosthesis/ complaints total knee arthroplasty

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Subject has a posterior stabilized knee prosthesis with a femur component made of Co-Cr-Mo, a tibia component made of Ti-6Al-4V, a polyethylene liner and optionally a polyethylene patella button - Patient has signed informed consent - Patient is older than 18 years

Exclusion criteria

Exclusion criteria: - Patient has an inability to stand for 15 minutes, without assistance - Patient is not eligible for MRI, based on MRI screening questionnaire - Pregnancy - The knee of the patient does not fit in the RF knee coil

Design outcomes

Primary

Measure	Time frame
The main study parameters for assessing patellofemoral maltracking are patellofemoral indices which are used for assessing patellar height and medial-lateral patellar displacement. For the statistical analysis, a within subject analysis is performed. The main study parameters for assessing component rotation are angle measurements which are used for assessing femoral and tibial component rotation. The assessment of soft tissue deformities will be performed by a segmentation of the structures of interest and comparing the volume and length of these structures with the knee in extension and multiple angles of flexion. For the statistical analysis, a within subject analysis is performed in which the structures will be visually inspected. The main study parameter to assess component loosening is the amount of fluid in the knee around the knee prosthesis. It is expected that compared to the control group patients with suspected component loosening have an increased amount of fluid around the kneeprosthesis.	—

Measure

Time frame

The main study parameters for assessing patellofemoral maltracking are patellofemoral indices which are used for assessing patellar height and medial-lateral patellar displacement. For the statistical analysis, a within subject analysis is performed. The main study parameters for assessing component rotation are angle measurements which are used for assessing femoral and tibial component rotation. The assessment of soft tissue deformities will be performed by a segmentation of the structures of interest and comparing the volume and length of these structures with the knee in extension and multiple angles of flexion. For the statistical analysis, a within subject analysis is performed in which the structures will be visually inspected. The main study parameter to assess component loosening is the amount of fluid in the knee around the knee prosthesis. It is expected that compared to the control group patients with suspected component loosening have an increased amount of fluid around the kneeprosthesis.

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Secondary

Measure	Time frame
Secondary endpoints are the inter-observer agreement and intra-observer agreement. These are calculated using the Cohen*s kappa coefficient. The results of two researchers will be included for these calculations.	—

Countries

Netherlands

Outcome results