The primary objective of this study is to determine the femorotibial and patellofemoral weight bearing in vivo kinematics of Journey II BCS TKA patients and to determine correlations that the kinematics may have with patient-reported outcome…
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Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The weight-bearing kinematics will be assessed using traditional 3D-to-2D
registration techniques. Raw data consists of the fluoroscopy video, and using
registration techniques, we are able to extract the 3D position of the
components and then analyze various parameters-of-interest, such as medial
condyle contact position.
Specific femorotibial parameters of interest will include maximum flexion,
anterior/posterior motion of the medial and lateral condyles, axial rotation
throughout each activity, and cam/post engagement angles (if applicable). In
other words, researchers will determine the relative motion of the femoral
component atop the tibial component as patients flex their knee. Patellofemoral
kinematics will include in vivo patellofemoral contact pattern in the sagittal
plane, in vivo patellar tilt in the sagittal plane with respect to tibia bone,
patellofemoral separation, and patella ligament rotation in the sagittal
plane. All parameters of interest will be measured directly from the
fluoroscopy images.
Secondary outcome
VAG signals will be correlated to cam-post engagement times. Specifically,
when the posterior cam/post engage (determined from the fluoroscopy overlays),
we will observe the filtered VAG signals to determine if there is a spike in
the signal data. Additionally, signals will be evaluated for noisy versus
quiet signals, based on signal amplitude, and this will be correlated to
weight-bearing kinematics as well as outcome scores.
Patient-reported Outcome Measures will be collected by the Forgotten Joint
Score, the Oxford Knee Score, KOOS-PS, NRS for pain and satisfaction. All
surveys have been previously validated.
Functional outcome parameters will be assessed by two mobility tasks, including
gait and sit-to-stand transfers. Specifically, patients will walk for 2 minutes
back and forth a 10m trajectory making 180* turns. This task will be repeated
while performing a secondary, cognitive task to evaluate the level of attention
they need for this task. Subsequently, the participants will be instructed to
rise from a chair at their comfortable speed. During these tasks, inertial
measurement units will be used to record the tasks and obtain spatiotemporal
outcome measures.
Background summary
Although total knee arthroplasty (TKA) is a successful orthopedic procedure of
today, many patients are unsatisfied with their implanted knee when having to
perform higher flexion activities such as a squat. Patients often feel anterior
knee pain, tightness, or a loss of range of motion in their implanted knees. To
improve the performance of total knee replacement systems, implant
manufacturing companies rely on in-vivo fluoroscopic testing and patient
reported outcome measures to determine to provide feedback. Unfortunately,
most of the research conducted today focuses primarily on well-performing
implants, using outcome scores as inclusion criteria to ensure satisfied
patients, and therefore does not provide insight into patients who may not be
as satisfied with their implanted knee. Additionally, scores self-reports by
patients measure a different construct of physical function - related to
perceived abilities - compared to the actual performance of a task, and
self-reported scores are highly subjective and are strongly dominated by pain.
To specifically improve the performance of a bi-cruciate substituting TKA
system, we want to conduct a fluoroscopic evaluation of this TKA system without
using *success* or *scores* as inclusion criteria. This will help us better
understand how this system will perform across a broad spectrum of patients and
will provide further insight into areas of improvement that total knee
replacement systems may have, to ultimately reduce the number of postoperative
complications or unsatisfied patients in the future.
Study objective
The primary objective of this study is to determine the femorotibial and
patellofemoral weight bearing in vivo kinematics of Journey II BCS TKA patients
and to determine correlations that the kinematics may have with
patient-reported outcome measures (patient-reported, clinical reported, and
functional outcome). Secondary objectives include correlations between
vibroarthrography (VAG) signals, in vivo kinematics, and outcome scores.
It is hypothesized that the participants with higher scores will have a better
weight bearing kinematics (larger range-of-motion, more condylar rollback,
better patellar tracking) than participants with lower scores. More
specifically, we are hypothesizing that an increase in PROMs will correlate
with more condylar rollback, more normal patellar height classifications (alta,
norma, baja), improved functional outcomes, less attention during gait, and
less VAG noise. These evaluations will provide insight into potential areas of
improvement for total knee replacement systems, to ultimately reduce the number
of postoperative complications in the future.
Study design
This is a cohort study. Patients will not undergo assigned treatments or
interventions but will undergo new assessments. Data will be collected for
participants on a single day, and there will be no follow-up.
Study burden and risks
This study will require the use of X-Rays to collect data. Thus, participants
will be exposed to radiation beyond their normal standard of care. However,
the doses of radiation exposure received by participants in this study will be
much lower than those known to produce detectable health effects. The
measurement used to monitor the amount of radiation a patient receives is the
millisieverts (mSv).
For this study, participants will be limited to a maximum of 2 minutes of
fluoroscopy time. A previous fluoroscopy TKA study conducted at another
hospital with a 2 minute limit showed that the average fluoroscopy time was 16
seconds with a maximum of 37 seconds. Additionally, average radiation exposure
amount was 0.018 mSv with a maximum dose of 0.050 mSv. At these dose levels,
no harmful effects of radiation have been demonstrated and any effect is too
small to measure. Therefore, the risk associated with this study is believed to
be minimal.
Since the fluoroscopy data will be collected in one session, there will only be
one day in which the participants will be exposed to this amount of radiation.
Fluoroscopic parameters will be recorded for each participant on their CRF,
including on-time, kV, mA, and any other dose report data from the fluoroscopy
unit. Data collection will stop if the 2-minute time limit is approached. To
keep radiation time as low as reasonably achievable (ALARA), the participant
will practice the activity before the fluoroscopy system is turned on, to
ensure they can comfortably and painlessly complete the motion.
Luttrell St 814
Knoxville, TN 37917
US
Luttrell St 814
Knoxville, TN 37917
US
Listed location countries
Age
Inclusion criteria
1. Subjects will have the appropriate TKA system: a Smith & Nephew Journey II
BCS TKA.
2. Patients in the age range of 18 years to 85 years (both inclusive)
3. Patients who do not have previous surgery on either knee that might
restrict their movement
4. Patient who are at least 6 months post-operative
5. Patients will be less than 11 years post-operative.
6. Patients who can perform the requested activity safely
7. Patients who are willing to participate in this study and are willing to
sign appropriate informed consent forms
Exclusion criteria
1. Female patients who are pregnant, trying to become pregnant, or lactating.
2. Patients who have enrolled in a fluoroscopic kinematic study within the
past year.
3. Patients with neurological or musculoskeletal disorders that might
adversely affect weight-bearing motion ability.
Design
Recruitment
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 | NL85398.091.23 |