To compare two surgical techniques in the treatment of patients with a anterior CECS.Surgical method 1: use of conventional *Due* fasciotome Surgical method 2: use of the new *Fasciomax©* in stead of the *Due*-fasciotome.
ID
Source
Brief title
Condition
- Connective tissue disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome of the study is post-operative pain in the entry site and the
leg in general, which patients will note on a daily basis for 2 weeks after
surgery using a 11-point Numerical rating scale. This will be done for both
separate legs. Furthermore, patients will note pain medication. Both will be
collected in a questionnaire.
Secondary outcome
Efficacy (3 months after surgery) and the occurrence of complications.
Efficacy will be determined by assessing complaint reduction using
questionaires ( pre-operative and 3 months post operative). Patients will
denote their complaints (pain, cramps, muscle weakness, tight feeling,
sensibility disorders) using a 5-point Verbal Rating Scale
Complications will be assessed by the responsible physician 2 weeks after
surgery.
Background summary
In some patients chronic lower leg pain is caused by a chronic exertional
compartment syndrome (CECS) which is characterized by high pressure in muscle
compartments. In most patients with CECS, pain is caused by high pressure in
the anterior compartment which contains the anterior tibial muscle. When
diagnosed via pressure measurement, surgical treatment is initiated. Due to the
lack of evidence for conservative treatment the current gold standard for
treating CECS is to surgically split the tight fascia surrounding the muscle.
Thereby the increased pressure in the compartment is abolished and the pain is
relieved. Splitting the fascia is performed using a fasciotome. In the Maxima
Medical Center a Due fasciotome is used. Acoording to own patientdata and
literature concerning prospective studies the succesrate after a fasciotomy
using the 'Due' fasciotome is on average 83%. An avoidable cause is suboptimal
execution of the fasciotomy. A half-closed fasciotomy, according to 'Due' has
potential riks and complications: 1. the unprotected mouth could rupture
bloodvessels causing bleeding and hematoma's; 2. by executing the fasciotomy
'blinded', nerves that are located next to the fascia can be damaged, resulting
in sensory disorders; 3. uncomplete splitting when the fasciotome losed contact
with the fascia; some patients have multiple fascia's that overlap. When using
the 'Due' fasciotome only one fascia is split.
Recently, a new surgical tool has been designed in the Maxima Medical center to
use during the procedure: the Fasciomax©. This fasciotome consists of a long
mouth that is able to enclose the entire fascia prior to cleaving it. Thereby
there is reduced chance of damaging vessels or nerves and incomplete
cleaving.
Study objective
To compare two surgical techniques in the treatment of patients with a anterior
CECS.
Surgical method 1: use of conventional *Due* fasciotome
Surgical method 2: use of the new *Fasciomax©* in stead of the *Due*-
fasciotome.
Study design
Single centre, single surgeon, patient-blinded randomized clinical trail.
Intervention
Included patients with double-sided CECS will undergo surgery with the Due
fasciotome in one lower leg, while in the other lower leg the Fasciomax© will
be used. The allocation of the intervention to either the right leg of left leg
is randomized. Save the use of a different fasciotome the procedure and care
for both legs is exactly equal.
Study burden and risks
It is expected that participation to this study will not induced additional
risks for the participants. However, participants are burdened with a extensive
questionaire (2 times), and denoting daily pain scores the first 2 weeks
following surgery.
Potential benefits are a reduction of post-operative pain and a reduced risk
for complications.
de Run 4600
Veldhoven 5504 DB
NL
de Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
- Male and female patients who are older than 18 years
- Chronic anterior compartment syndrome proven by clinical history, physical examination and pressure measurement
- Only the anterior lower leg compartment is affected, no combined compartment syndrome including lateral of posterior compartment involvement.
- Patients have comparable complaints in both lower legs
- Patients have given informed consent.
Exclusion criteria
- Previous lower leg surgery
- Previous traumatic lower leg bone fracture
- Patients do not speak/underrstand Dutch
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL44917.015.13 |
| OMON | NL-OMON23754 |