The aim of this study is to image and model patient specific ACL-deficient knees applying several developed methods, to determine the feasibility of PKTD and MRI based FE models in assessing knee laxity in ACL-deficient knees before and after…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameters (antero-posterior and rotational laxity) will be
statistically analyzed using a t-test or a paired t-test. The difference in
rotation due to the attachment sides will be analyzed using Spearmen
correlation. Additionally, regression analysis is used to determine the
reliability of the clinical tests compared to the PKTD. Because, this is a
feasibility study all p-values generated in hypothesis testing will be
interpreted within the context of an explorative study.
Secondary outcome
n.v.t
Background summary
Many musculoskeletal diseases, such as ACL ruptures, are related to
biomechanical factors. The tools used by clinicians and researches to assess
the biomechanical condition of patients, such as Lachman test and MRI, are
often crude and subjective, leading to non-optimal patient analyses and care. A
recently developed tool; Porto Knee Testing Device, was found reliable in
quantitative assessment of knee laxity, using simple distance parameters. MRI
based FE analysis in clinical environment has become more promising over the
last years. Using these 3D computer models in addition to the MRI PKTD scans,
it could give more information about the deficient ACL, and/or about the
reconstruction. However, no studies ever have combined the PKTD with MRI based
FE models.
Study objective
The aim of this study is to image and model patient specific ACL-deficient
knees applying several developed methods, to determine the feasibility of PKTD
and MRI based FE models in assessing knee laxity in ACL-deficient knees before
and after reconstruction, and to determine the influence of the ACL attachment
sides on mechanical performance of the knee joint. The additional aim is to
determine the reliability of assessing knee laxity using the PKTC compared to
the Lachman test (before and after reconstruction) and the pivot-shift test
(before reconstruction).
Study design
A total of 8 subjects with an ACL rupture in one knee, who are planned for
hamstrings tendon reconstruction are included in the study. The subject should
be older than 18 years and give informed consent. Antero-posterior and
rotational laxity of the knee is determined using Lachman test, pivot-shift
test, PKTD MRI scans and a 3D finite element model. Additionally, the ACL
attachment sides are obtained before and after reconstruction. Before the
reconstruction surgery both, healthy and injured, knees will be scanned and
tested with the Lachman and pivot-shift test. Three months after the
reconstruction, only the reconstructed knee will be scanned and tested using
the Lachman test. The MR images will be used as input for the finite element
model, after segmentation and meshing.
Study burden and risks
Subjects who participate in the study do not have any direct benefit of
participation. The risk associated to the MRI scan, PKTD, or the other clinical
tests are completely non-invasive and as such the health risk involved for
participating subjects can be deemed negligible. The outcome of this study will
inform researchers and clinicians of a new technology to improve future ACL
reconstructions.
Meibergdreef 9 10
Amsterdam 1105AZ
NL
Meibergdreef 9 10
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
The subject should be 18 years old or older.
The subject should have an ACL rupture in one knee.
The subject should have a non-ACL deficient knee.
The subject should be able to read and understand the subject information.
The subject should be planned for a hamstrings tendon revision.
Exclusion criteria
The subject has a joint replacement implant.
The subject has lower limb arterial insufficiency.
The subject has venous diseases.
The subject has haemophilia.
The subject has known or suspected osteoporosis.
The subject has a bone disease with bone fragility.
The subject cannot articulate pain or discomfort.
The subject does not meet standard criteria for MRI scanning.
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 | NL52734.018.15 |