The Research About Acute Compartment Syndrome

Acute Compartment Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Compartment Syndrome
• Intervention / Treatment: Procedure: fasciotomy

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Ma Lijie, Doctor

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The Third Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The severe tibial plateau (Ⅴand Ⅵ according to Schatzker's classification) in our hospital who will be treated with open internal fixation in our hospital

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
fractures with blister appeared; tibial plateau fractures with blister observed	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
fractures without blister appeared; tibial plateau fractures without blister observed	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
the time when the blister appeared	The relative data was collected about the time when the blister appeared after injury	up to 4 weeks
time to reconstructive surgery	The relative data was collected about time to reconstructive surgery	time to when the surgery was conducted after 2 weeks
union time	The relative data was collected about union time	through study completion, an average of 1 year
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
secondary loss of reduction	The relative data was collected about complications	through study completion, an average of 1 year
Deep venous thrombosis	The relative data was collected about complications	through study completion, an average of 1 year
superficial wound problems	The relative data was collected about complications	through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
CK levels	CK levels	through hospitalization completion, an average of 1 month
chloride levels	chloride levels	through hospitalization completion, an average of 1 month
UREA levels	UREA levels	through hospitalization completion, an average of 1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
LKS score	Lysholm knee score	through study completion, an average of 1 year
VAS scores	visual analogue scale	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Hebei Medical University Third Hospital
• Investigators: Principal Investigator: Hou Zhiyong, Doctor, Hebei Medical University Third Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): September 9, 2022
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: ACS; Tibial plateau fractures; Tibial shaft fractures
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Musculoskeletal Diseases; Muscular Diseases; Syndrome; Compartment Syndromes
• Other Study ID Numbers: HZY001ACS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: acute compartment syndrome
• IPD Sharing Time Frame: 2 years after the experiment was conducted
• IPD Sharing Access Criteria: all authors focusing on ACS research
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No