Validation and implementation of the Comforthod-Knee System for accurate diagnosis of mechanical loosening and movement of a metal implant in the human body.

Validation and implementation of the Comforthod-Knee System for accurate diagnosis of mechanical loosening and movement of a metal implant in the human body. - Diagnosis of mechanical loosening using the Comforthod Knee System.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52996

Enrollment

Registered

2015-04-07

Start date

2015-12-01

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Knie prothese aseptic loosening mechanical loosening

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Patients diagnosed with aseptic loosening of the knee prosthesis and that are scheduled for revision surgery. - Patients with a TKA who are asymptomatic and have no complaints oftheir knee prosthesis. - Patients capable of giving informed consent and are willing to do this extra examination

Exclusion criteria

Exclusion criteria: - Patients with another cause for revison surgery besides aseptic loosening. - Patients who are unable or unwilling to sign the informed consent for this study.

Design outcomes

Primary

Measure	Time frame
The primary outcome measure of this study is the amount of movement of the prosthesis relative to adjacent bone. The amount of movement is expressed in movement in the screw axis, rotation of the prosthesis and movement in the x, y and z plane. These outcomes will be compared with the findings of the standard care pathway and the findings during revision surgery. The amount of movement of the prosthesis relative to the adjacent bone as measured in asymptomatic patients will be compared to amount of movement found by Comforthod system in patients were the TKA was found to be loose intra-operatively.	—

Measure

Time frame

The primary outcome measure of this study is the amount of movement of the prosthesis relative to adjacent bone. The amount of movement is expressed in movement in the screw axis, rotation of the prosthesis and movement in the x, y and z plane. These outcomes will be compared with the findings of the standard care pathway and the findings during revision surgery. The amount of movement of the prosthesis relative to the adjacent bone as measured in asymptomatic patients will be compared to amount of movement found by Comforthod system in patients were the TKA was found to be loose intra-operatively.

—

Secondary

Measure	Time frame
Secondary outcome measure is the difference between the two groups in the amount of prosthesis movement with the adjacent bone. The amount of movement is expressed in movement in the screw axis, rotation of the prosthesis and movement in the x,y and z axis.	—

Countries

Netherlands

Outcome results