The objective of this study is to quantify the subjective feeling of knee (in)stability during a stair descent. This results in the following research question:*Is there a relation between the kinematics of the knee joint from people who suffer from…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
In addition, alignment, functional tests, objective laxity tests performed with
radiographs, 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.
Background summary
As the life expectancy of people rises due to advancements in healthcare, the
number of total knee arthroplasties (TKAs) performed increases. This has led to
a rise in the number of TKA revisions, which almost doubled between 2010 and
2022.
In 25% of revision cases, instability is at least one of the reasons to proceed
to surgery. Unfortunately, instability is poorly understood as the subjective
reports of the patient often do not correlate with objective diagnostic tests
used by a clinician. Finding a measure that better correlates with the
subjective complaints can help understand instability and how to treat it.
Study objective
The objective of this study is to quantify the subjective feeling of knee
(in)stability during a stair descent. This results in the following research
question:
*Is there a relation between the kinematics of the knee joint from people who
suffer from knee instability during a stair descent activity and their
self-perceived feelings of joint instability?*
We hypothesize that patients who report having an unstable TKA have more
translation of their femoral condyles with respect to the tibia component of
their TKA during stair descent than patients who report having a stable TKA.
Study design
This is an observational study comparing knee kinematics of TKA-patients with
instability complaints to TKA-patients without complaints using fluoroscopy.
During the site visit, patients will perform a stair descent activity, which
will be recorded using a fluoroscope. From these fluoroscopic images, the
precise movements of the femoral condyles can be investigated throughout the
range of motion during the stair descent activity. The movements of the femoral
condyles will be related to the self-perceived instability of the subjects.
Study burden and risks
The tests done for this study will take about two hours per participant. For
the cases-group, these tests will be planned, as much as possible, during their
scheduled visits to the clinic. The patients in the control-group will need to
visit the clinic once outside of their usual care to perform the tests. The
additional radiological assessments have a total amount of radiation that leads
to a very small extra risk, there are no additional risks to the tests. The
questionnaires and physical examination of the knee do not bring much extra
burden.
Hengstdal 3
Nijmegen 6574 NA
NL
Hengstdal 3
Nijmegen 6574 NA
NL
Listed location countries
Age
Inclusion criteria
- Subjects who have a primary Genesis PS TKA system
- Subjects 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 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
motion
- Subjects who are at least two years post-operative
- Subjects who can perform the requested activities safely
- Subjects who are willing to participate in this study and are willing to sign
appropriate informed consent
forms
Exclusion criteria
- Female patients who are pregnant, trying to become pregnant, or lactating
- Patients who have enrolled in a fluoroscopic kinematic study within the past
year
- Patients with neurological or musculoskeletal disorders that might adversely
affect weight-bearing motion ability
- Patients whose body size exceeds the limits that can be accommodated by the
equipment
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 | NL87109.091.24 |