To analyse the accuracy of the positioning of the catheter that is used for pressure measurement deep flexor muscles of the lower leg using magnetic resonance imaging (MRI).
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To verify proper catheter placement in the muscle compartment using MRI.
Secondary outcome
Results of the MRI will be used to closely describe the individuals* anatomy.
Background summary
Some patients with chronic lower leg pain suffer from a chronic exertional
compartment syndrome (CECS) characterized by too high pressures in muscle
compartments. A substantial portion of patients harbour a CECS of the deep
flexor muscles of the lower leg. The diagnosis is attained using dynamic
intracompartmental pressure measurement (ICP). A patient receives a small
catheter in the affected compartment, and pressures are measured in rest and
after a standard exercise test (running on a treadmill). The current technique
is based on anatomic landmarks as suggested in literature. Results of surgery
for deep flexor muscles CECS are suboptimal. To date, factors associated with a
beneficial outcome after fasciotomy for deep posterior CECS have not been
identified. We hypothesize that fair results may be related to the suboptimal
accuracy of the current insertion technique. We propose to determine the
accuracy of in vivo catheter placement in patients with suspected CECS of the
deep flexor muscles of the lower leg.
Study objective
To analyse the accuracy of the positioning of the catheter that is used for
pressure measurement deep flexor muscles of the lower leg using magnetic
resonance imaging (MRI).
Study design
a descriptive pilot study
Study burden and risks
All patients with a clinical suspicion of deep posterior CECS undergo needle
insertion for catheter placement for ICP as is the gold standard procedure.
Over the preceding years, more than 500 procedures have been safely performed
in our MMC hospital. In this study, patients will additionally undergo a lower
leg MRI immediately after ICP. No extra risk is associated with participation
in this study other than associated with a standard MRI test.
De Run 4600
Veldhoven 5504DB
NL
De Run 4600
Veldhoven 5504DB
NL
Listed location countries
Age
Inclusion criteria
Healthy individuals aged >18 with suspected CECS of deep flexor muscles of the lower leg requiring an intracompartmental pressure measurement (ICP).
Exclusion criteria
<18 years
History of: operation in the leg (especially intramedullar pen or plate materials)
Fracture
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 | NL41251.015.12 |