The Research About Acute Compartment Syndrome

Recruiting

• Conditions: Acute Compartment Syndrome
• Interventions: Procedure: fasciotomy

• Registration Number: NCT04529330
• Lead Sponsor: Hebei Medical University Third Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-27
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-08-04
• Primary Completion: 2022-09-09
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
fractures with blister appeared	fasciotomy	tibial plateau fractures with blister observed
fractures without blister appeared	fasciotomy	tibial plateau fractures without blister observed

Primary Outcome Measures

Name	Time	Method
the time when the blister appeared	up to 4 weeks	The relative data was collected about the time when the blister appeared after injury
No non-anatomic gap or step (larger than 5 mm)	through study completion, an average of 1 year	The relative data was collected about complications
secondary loss of reduction	through study completion, an average of 1 year	The relative data was collected about complications
superficial wound problems	through study completion, an average of 1 year	The relative data was collected about complications
blister skin immunochemistry and immunofluorescence analysis	through study completion, an average of 1 year	CK1, 5, 10, claudin 1, 2 and occludin as determined by immunochemistry analysis, and skin barrier proteins; claudin 1, 2 and occludin was determined by immunofluorescence analysis and qPCR.
injury mechanism	up to 1 weeks	The relative data was collected about injury mechanism such as high falling accident, traffic accident, fall from standing height,Crushing
time to reconstructive surgery	time to when the surgery was conducted after 2 weeks	The relative data was collected about time to reconstructive surgery
union time	through study completion, an average of 1 year	The relative data was collected about union time
Deep venous thrombosis	through study completion, an average of 1 year	The relative data was collected about complications

Secondary Outcome Measures

Name	Time	Method
chloride levels	through hospitalization completion, an average of 1 month	chloride levels
UREA levels	through hospitalization completion, an average of 1 month	UREA levels
CK levels	through hospitalization completion, an average of 1 month	CK levels

Trial Locations

Locations (1)

the Third Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China