The main objective is to investigate the fixation of the Journey II XR BCR TKA in terms of micromotion of the femoral and tibial components over time measured by RSA. Secondary, this study aims to assess the effect of this BCR TKA on daily life…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Bicruciate Retaining (BCR) Total Knee Arthroplasty (TKA) is thought to maintain
a closer resemblance to the normal knee function and feel compared to cruciate
retaining or cruciate substituting techniques. With this technique both
cruciate ligaments are preserved which is thought to lead to enlarged
proprioception and stability in the knee. However, because of the difficult
surgical technique due to retaining both cruciate ligaments, initial stability
of this type of prosthesis in terms of fixation is unclear Therefore this study
aims to investigate the fixation of the Journey II XR BCR TKA over time
measured by radiostereometric analysis (RSA). Secondly, gait quality assessed
in daily life and challenging lab-based skills tasks is compared to healthy
controls. It is expected that the prosthesis might show some early micromotion
until 6 months post-operatively followed by stabilization, showing a fixation
pattern comparable to other TKAs. Gait quality is expected to improve from pre-
to post surgery for all patients, resembling the gait of healthy controls.
Study objective
The main objective is to investigate the fixation of the Journey II XR BCR TKA
in terms of micromotion of the femoral and tibial components over time measured
by RSA. Secondary, this study aims to assess the effect of this BCR TKA on
daily life functioning and to investigate whether the patients have natural
knee kinematics and physiological motion compared to a healthy cohort.
Study design
This is a prospective study comparing the fixation of the implant during
hospitalization, 6 weeks, 3 months, 6 months, 1 year and 2 years
post-operatively. For the secondary objectives a healthy cohort is recruited to
compare the gait quality pre-operatively, 1 year and 2 years post-operatively.
Study burden and risks
The burden of participation consists of 9 additional (stereometric)
radiological assessments, but the total amount of radiation that participants
will receive provides only a low chance of extra risk. Participants will take
part in 3 gait assessments at the Sint Maartenskliniek (Pre-operatively, 1 year
and 2 years post-operatively, 2-3 hours each) and around these time points are
also asked to wear inertial sensors at home for 5 days. Risks of the gait
assessment in the clinic are minimal as the subjects will be wearing a harness
to prevent falls. Additionally, questionnaires and CROMs/PROMs will be assessed
during their visits to the clinic. The risks related to the surgery are minimal
and are not higher than the conventional knee prosthesis placed in our
hospital.
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71885.091.19 |