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Recruiting NCT04529330

The Research About Acute Compartment Syndrome

Observational Acute Compartment Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fasciotomy.
Who it may be relevant to
Registry conditions: Acute Compartment Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Acute Compartment Syndrome

Overview

Acute compartment syndrome (ACS) is defined as a clinical entity originated from trauma or other conditions, and remains challenging to diagnose and treat effectively. Threre is the controversy in diagnosing, treating ACS. It was found that there was no criterion about the ACS, and result unnecessary osteotomy. The presence of clinical assessment (5P) always means the necrosis of muscles and was the most serious or irreversible stage of ACS. Besides pressure methods, the threshold of pressure identifying ACS was also controversial.

Interventions

  • Procedure fasciotomy
    if it was suspected with ACS, the fasciotomy was conducted. but if the blister observed, it means decreased conmpartment sydrome. therefore, the blister observed can avoid unnecessary fasciotomy to patients suspected with ACS

Primary outcome measures

  • injury mechanism [Time frame: up to 1 weeks]
  • the time when the blister appeared [Time frame: up to 4 weeks]
  • time to reconstructive surgery [Time frame: time to when the surgery was conducted after 2 weeks]
  • union time [Time frame: through study completion, an average of 1 year]
  • No non-anatomic gap or step (larger than 5 mm) [Time frame: through study completion, an average of 1 year]
  • secondary loss of reduction [Time frame: through study completion, an average of 1 year]
  • Deep venous thrombosis [Time frame: through study completion, an average of 1 year]
  • superficial wound problems [Time frame: through study completion, an average of 1 year]
  • blister skin immunochemistry and immunofluorescence analysis [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (3)
  • CK levels [Time frame: through hospitalization completion, an average of 1 month]
  • chloride levels [Time frame: through hospitalization completion, an average of 1 month]
  • UREA levels [Time frame: through hospitalization completion, an average of 1 month]

Eligibility criteria

Inclusion criteria

  • Fracture patients with Schatzker V and VI,
  • Who were older than eighteen years.

Exclusion criteria

  • The exclusion criteria were pathologic, extra-articular proximal tibial fracture,
  • Patients who was eighteen years or younger.
  • Patients treated with other implant,
  • underwent conservative management were also excluded.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

China · 1 center
  • the Third Hospital of Hebei Medical University — Shijiazhuang

Publications

  • Guo J, Yin Y, Jin L, Zhang R, Hou Z, Zhang Y. Acute compartment syndrome: Cause, diagnosis, and new viewpoint. Medicine (Baltimore). 2019 Jul;98(27):e16260. doi: 10.1097/MD.0000000000016260. PMID 31277147
  • Wang T, Yang S, Guo J, Long Y, Hou Z. Predictors of muscle necrosis in patients with acute compartment syndrome. Int Orthop. 2023 Apr;47(4):905-913. doi: 10.1007/s00264-023-05699-9. Epub 2023 Jan 30. PMID 36715712

Identifiers

NCT: NCT04529330 · HZY001ACS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗