To perform a pilot study to optimise reproducible dynamic 4D CT scanning of the knee in evaluating patellar tracking and to reduce the radiation dose needed. The outcome of this pilot study will be used to perform a study on healthy subjects to…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the lowest possible dose to have an accurate
measurement of knee movement in a dynamic CT scan, to be able to perform
studies on healthy subjects.
Secondary outcome
The secondary endpoints are the knee movements as mentioned in the main study
parameter; relation between the flexion angle of the knee, the TTTG distance,
tibial rotation, patellar tilt and mediolateral displacement of the patella.
Background summary
A patellar dislocation is one of the most common acute knee disorders in
children and adolescents. One of the main reasons for the instability is an
excessive tibial tubercle-trochlear groove (TTTG) distance. In order to solve
this problem, a tibial tubercle transposition can be performed. However, the
normal values for TTTG and the amount of correction that should be performed
remain uncertain. The reported normal values in asymptomatic individuals vary
substantially and are measured in complete extension of the knee. However, the
TTTG is depending on the flexion angle of the knee. This is probably due to a
relation between the TTTG and tibial rotation. To investigate this, we want to
make the new technique of dynamic 4D CT scanning of the knee applicable with
the lowest dose possible. This will provide a way to better understanding of
patellofemoral tracking and improve the surgical planning.
Study objective
To perform a pilot study to optimise reproducible dynamic 4D CT scanning of the
knee in evaluating patellar tracking and to reduce the radiation dose needed.
The outcome of this pilot study will be used to perform a study on healthy
subjects to determine normal values of dynamic patellar tracking.
Study design
Prospective single centre observational study
Study burden and risks
All patients will have one 4D dynamic CT scan of both knees. This CT is
associated with an ionising radiation dose of 0.3 millisievert (mSv), compared
to normal preoperative CT scan of the knee of 0.02 mSv. This will burden a
trivial risk compared to the natural background radiation in the Netherlands
(2mSv).
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
* Age 18 years and older.
* Recurrent patellofemoral instability, in which the conservative management has failed.
* A preoperative CT scan is required.
Exclusion criteria
* Patients below age of 18 years.
* Patients with prior surgery of the knee.
* Subjects not able to active flex and extend the knee.
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 | NL60392.091.17 |