The main objective is to identify objective, neuromuscular and/or mechanic parameters through movement analysis, which are closely correlated to the subjective outcome of TKA. Secondary objective is to generate parameter specific hypotheses for our…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The magnitude of the knee adduction moment (KAM) is generally considered as a
surrogate for medial compartment loading and a proxy for knee osteoarthritis.
There have been studies linking the magnitude of the KAM, sometimes in
combination with alterations in the knee flexion moment (KFM), to the outcome
of TKA. However it can not (yet) be correlated to a dissatisfied/bad outcome of
TKA, since patients haven't been selected based on their outcome. We
hypothesize that the magnitude of the KAM in patients who are dissatisfied with
the outcome of their TKP is greater than in patients who are satisfied with the
outcome of their TKP.
Secondary outcome
Loss of cartilage can lead to knee instability, as a consequence of
compensating for instability muscular co-contractions become present. Muscular
co-contractions around the knee increase the compressive force on the knee
joint. Together with the knee adduction moment (KAM) and knee flexion moment
(KFM) represents this the load on the knee joint. The knee range of motion is
of significant importance regarding the magnitude of the KAM and KFM, since it
determines the size of the lever-arm on the Ground Reaction Force. Therefore
these parameters will be analyzed as secondary parameters.
Background summary
Generally, a Total Knee Arthroplasty (TKA) is an effective treatment for
patients suffering from severe knee osteoarthritis (KOA). On average 80-90% of
the patients undergoing TKA are satisfied with the outcome. However, at least
10% suffers from persisting pain in the knee and/or a decrease in Range of
Motion (ROM). Studies regarding the outcome of TKA generally focus on outcome
measurements using PROMs (Patient reported outcome measures), which lack
sensitivity, limiting their application to individual-level. These
questionnaires are important in evaluating the overall outcome following knee
arthroplasty; however they offer no objective clinical data concerning the
patients* specific functional abilities as they primarily reflect reduction in
pain. Additionally most of these questionnaires are influenced by the
subjectivity of the research participant. This study aims to evaluate the
kinematics and kinetics of the knee after TKA and to define objective
measurement parameters to evaluate the outcome. We aim to identify mechanical
and neuromuscular parameters that significantly differ between patients who are
satisfied with their total knee prosthesis (TKP) and patients who are
dissatisfied, according to the PROMs. Gaining insight in how these parameters
behave after TKA will not only provide an objective outcome measurement, but
will also help evaluate how patients mechanically benefit from TKA. This study
will also help in generating hypotheses for further prospective studies
regarding outcome-predictive factors for TKA.
Study objective
The main objective is to identify objective, neuromuscular and/or mechanic
parameters through movement analysis, which are closely correlated to the
subjective outcome of TKA. Secondary objective is to generate parameter
specific hypotheses for our future prospective observational study regarding
patients with severe knee osteoarthritis who will undergo TKA.
Study design
This is a cross sectional observational study between two groups selected based
on the outcome of their TKA as measured with various PROMs and validated
satisfaction scales for TKA.
Study burden and risks
The risks and burden of the experiments may be related to walking on the GRAIL
(dual-belt instrumented treadmill) while receiving real-time feedback. All
participants will wear a safety harness while walking on the GRAIL. From
previous experiments, we know that a 2-minute familiarization period on the
treadmill is sufficient in most of the persons. Measurements will not start
before research subjects indicate that they are comfortable with walking on the
treadmill.
Experiences with subjects to walk in a VR-environment, is that most patients
consider it fun to walk in this kind of *real world computer game*.
Patients will have to visit the VUmc only once for this study. Additional
questionnaires can be filled in during their visit. The visit will take about
1,5 - 2 hours in total.
de Boelelaan 1117
Amsterdam 1081 HZ
NL
de Boelelaan 1117
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
One total knee prosthesis placed >1 year ago, age ranging from 40 to 70 years old, able to walk at least 20 minutes without stopping.
Exclusion criteria
Other prosthesis lower extremities; instable contra-lateral knee; instability, malposition, loosening, or current infection of the prosthesis; neuromuscular disorder(s); history of stroke; gout; other hip/knee or ankle disorders which affect the gait pattern; general diseases which affect the gait pattern; BMI > 35.
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 | NL51829.029.14 |