The objective of this study is to accurately determine the kinematics of healthy subjects to be able to compare them with patients suffering from patellofemoral instability, by scanning volunteers without knee complaints using 4D dynamic CT imaging…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the determination of the healthy, normal
patellofemoral and tibiofemoral kinematics based on dynamic CT. For this
purpose the patella center - trochlear groove distance is examined.
Secondary outcome
The second outcome measure in this study is the Kujale Knee Score (KKS), a
patient reported assessment of patellofemoral disorders that evaluates
subjective symptoms and functional limitations.
Background summary
This study complements an earlier approved study (NL60392.091.17 / CMO
2017-3200). Patellofemoral instability is a common knee disorder in children
and young adults. In patients with patellofemoral instability the patella
(=kneecap) can luxate from the femoral trochlea (=groove). The disorder is
associated with pain, inability to ambulate, gait alteration and is linked to
early onset osteoarthritis in the patellofemoral joint. Primary treatment is
primarily conservative. However, if dislocations are recurrent, orthopaedic
surgery is considered to stabilize the joint. Although the surgical outcome is
generally good, a significant part of patients keeps having patellar
dislocations as well as an unstable feeling.
As part of the work-up for surgery currently a conventional CT study scan is
performed. As the underlying clinical problem of patellofemoral instability is
dynamic in nature, the conventional CT lacks important information on the
dynamic behaviour of the femur, patella and tibia. In the beforementioned
study we investigated the use of 4D dynamic CT imaging to automatically
determine knee kinematics while simultaneously establishing the optimal dose
for this purpose. With this newly established lower dose and optimized
protocol, we want to determine the baseline kinematics of normal, healthy
knees. This allows us to compare the kinematics of patients with the healthy
baseline, enabling us to improve surgical planning for patients with
patellofemoral instability and in the end, improve the clinical outcome.
Study objective
The objective of this study is to accurately determine the kinematics of
healthy subjects to be able to compare them with patients suffering from
patellofemoral instability, by scanning volunteers without knee complaints
using 4D dynamic CT imaging. .
Study design
Prospective single centre observational study
Study burden and risks
The risk of participating in this research is low.
During the research the participant will be exposed to a (very) small amount of
ionising radiation (X-rays). The total radiation dose to which the participant
will be exposed during this research is 0.08 mSv. By way of comparison, the
background radiation in the Netherlands due to natural radiation sources is
2mSv per inhabitant per year. A transatlantic flight involves a dose of 0.1 mSv.
The risk of this additional radiation load is therefore low.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Subject is between 18 and 35 years of age. Subject must not have prior
injuries, surgery to the knee, or any knee complaints. Subject hast signed
informed consent and has no more questions about the protocol.
Exclusion criteria
Subject is younger than 18 years. Subject has prior injuries to the knee or a
congenital disorder. Subject is unable to do a full extension /flexion
movement. Subject is pregnant. Subject has severe valgus coronal alignment of
the leg.
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 | NL72784.091.20 |