The Research About Acute Compartment Syndrome

Acute Compartment Syndrome Clinical Trial

Official title:

Acute Compartment Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04529330
• Other study ID #: HZY001ACS
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2030

Study information

• Verified date: July 2021
• Source: Hebei Medical University Third Hospital
• Contact: Guo Jialiang, Doctor
• Phone: 18203222090
• Email: drjlguo86[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2030
• Est. primary completion date: September 9, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Compartment Syndrome
• Compartment Syndromes
• Syndrome

Intervention

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

Locations

Country	Name	City	State
China	the Third Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	LKS score	Lysholm knee score	through study completion, an average of 1 year
Other	VAS scores	visual analogue scale	through study completion, an average of 1 year
Primary	injury mechanism	The relative data was collected about injury mechanism such as high falling accident, traffic accident, fall from standing height,Crushing	up to 1 weeks
Primary	the time when the blister appeared	The relative data was collected about the time when the blister appeared after injury	up to 4 weeks
Primary	time to reconstructive surgery	The relative data was collected about time to reconstructive surgery	time to when the surgery was conducted after 2 weeks
Primary	union time	The relative data was collected about union time	through study completion, an average of 1 year
Primary	No non-anatomic gap or step (larger than 5 mm)	The relative data was collected about complications	through study completion, an average of 1 year
Primary	secondary loss of reduction	The relative data was collected about complications	through study completion, an average of 1 year
Primary	Deep venous thrombosis	The relative data was collected about complications	through study completion, an average of 1 year
Primary	superficial wound problems	The relative data was collected about complications	through study completion, an average of 1 year
Primary	blister skin immunochemistry and immunofluorescence analysis	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.	through study completion, an average of 1 year
Secondary	CK levels	CK levels	through hospitalization completion, an average of 1 month
Secondary	chloride levels	chloride levels	through hospitalization completion, an average of 1 month
Secondary	UREA levels	UREA levels	through hospitalization completion, an average of 1 month