joint replacement total knee replacement
Conditions
Interventions
n.a.
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects who have a primary Genesis PS TKA systemSubjects in the cases-group should be up for a revision with the main reason being instability. This is defined as the indication for the revision as determined by the surgeon. To establish this diagnosis, infection (according to the ICM 2018 criteria), loosening, and patellar problems have been excluded. Although no clear and absolute definitions for malposition exist, it could be the cause of instability. However, the treating surgeon will decide which of the two complications is the main reason for revision. Patients with malposition and major deviation in alignment will not be included in the study. Subjects in the cases-group should be self-reported unstable, as defined as scoring either 1 or 2 points on questions 7, 10, and 12 of the Oxford knee score, which we deem important questions for people suffering from instability issues with their TKA.Subjects in the cases-group should not have had a previous minor revision with insert exchange meant to resolve the instability. Subjects falling in the control-group should have a good outcome of their TKA, as defined by having an Oxford Knee Score of above 30 and score at least 3 points on questions 7, 10, and 12, which we deem important questions for people suffering from instability issues with their TKA.Subjects who are in the age range of 40 to 85 years (both inclusive)Subjects who did not have had any previous surgery to their knee which could restrict their range of motionSubjects who are at least two years post-operativeSubjects who can perform the requested activities safelySubjects who are willing to participate in this study and are willing to sign appropriate informed consent forms
Exclusion criteria
Exclusion criteria: Female patients who are pregnant, trying to become pregnant, or lactatingPatients who have enrolled in a fluoroscopic kinematic study within the past yearPatients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion abilityPatients whose body size exceeds the limits that can be accommodated by the equipment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are the AP translation of the femoral condyles (in mm) and rotation of the femur component (in degrees) with respect to the tibia component during stair descent as measured on fluoroscopic images. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition, alignment, functional tests, objective laxity tests performed with radiographs, acceleration of the femur and tibia during stair descent obtained using intertial measurement units, and PROMS are investigated to see if they have a relation with the perceived instability of the patient and/or the movement patterns of the femur component with respect to the tibia component during the stair descent activity. | — |
Countries
Netherlands
Contacts
Public ContactT Droogsma
Sint Maartenskliniek
Outcome results
None listed