Compare two surgical techniques for treatment of posterior CECS.
ID
Source
Brief title
Condition
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in intracompartmental pressure measured by the dynamic pressure
measurement pre- and post-operatively.
Secondary outcome
The secondary study parameter is the change in pain in daily/sports activities
expressed by a VAS score.
Background summary
Surgery for a Chronic Exercise Induced Compartment Syndrome (CECS) of the
posterior muscles of the leg has poor post-operative results. Different
surgical techniques have been proposed but none has shown to be superior.
Study objective
Compare two surgical techniques for treatment of posterior CECS.
Study design
Randomised Controlled Trial
Intervention
Group 1: release of the fascia cruris
Group 2: release of the fascia cruris, as well as a release of the m. flexor
digitorum, while leaving the insertion in place. Inspection of the m. tibialis
posterior for an eventual extra compartment, and eventual release.
Study burden and risks
The main risk is that the group treated with the limited fasciotomy may be
under treated.
An additional risk is that the patients will have to undergo an extra
intra-compartmental pressure measurement post-operatively. Nevertheless, these
measurements are usually not associated with substantial health risks.
Other burdens will be an extra visit to the hospital for an MRI-scan
pre-operatively and questionnaires to be filled out.
de Run 4600
5500 MB Eindhoven
NL
de Run 4600
5500 MB Eindhoven
NL
Listed location countries
Age
Inclusion criteria
- individuals (m/f) suffering from CECS
- a positive dynamic compartment pressure measurement
- 18-40 years, since it s a sports-related injury and this is the predominant age group where CECS occurs
- sports-related
- just the deep posterior compartment involved. This can be determined by the pressure measurement
- failure of conservative management (physical therapy/inlays)
Exclusion criteria
Previous surgery on 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 | NL18179.015.07 |