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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44856
Enrollment
50
Registered
2013-09-05
Start date
2013-10-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anterior chronic compartment syndrome CECS (chronic exertional compartment syndrome)

Interventions

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 t

Sponsors

Maxima Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Previous lower leg surgery - Previous traumatic lower leg bone fracture - Patients do not speak/underrstand Dutch

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)