Comparison between two surgical methods in the treatment of anterior chronic compartment syndrome: a patient blinded, randomized study.

Completed

Conditions: 10010761
anterior chronic compartment syndrome
CECS (chronic exertional compartment syndrome)

Registration Number: NL-OMON44856

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome of the study is post-operative pain in the entry site and the<br /><br>leg in general, which patients will note on a daily basis for 2 weeks after<br /><br>surgery using a 11-point Numerical rating scale. This will be done for both<br /><br>separate legs. Furthermore, patients will note pain medication. Both will be<br /><br>collected in a questionnaire. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Efficacy (3 months after surgery) and the occurrence of complications.<br /><br>Efficacy will be determined by assessing complaint reduction using<br /><br>questionaires ( pre-operative and 3 months post operative). Patients will<br /><br>denote their complaints (pain, cramps, muscle weakness, tight feeling,<br /><br>sensibility disorders) using a 5-point Verbal Rating Scale<br /><br>Complications will be assessed by the responsible physician 2 weeks after<br /><br>surgery. </p><br>