Clinical trial NCT04529330: The Research About Acute Compartment Syndrome
Official title: Acute Compartment Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Compartment Syndrome
Keywords: ACS
Tibial plateau fractures
Tibial shaft fractures
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.


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.

Primary outcomes:
measure: injury mechanism
timeFrame: up to 1 weeks
measure: the time when the blister appeared
timeFrame: up to 4 weeks
measure: time to reconstructive surgery
timeFrame: time to when the surgery was conducted after 2 weeks
measure: union time
timeFrame: through study completion, an average of 1 year
measure: No non-anatomic gap or step (larger than 5 mm)
timeFrame: through study completion, an average of 1 year
measure: secondary loss of reduction
timeFrame: through study completion, an average of 1 year
measure: Deep venous thrombosis
timeFrame: through study completion, an average of 1 year
measure: superficial wound problems
timeFrame: through study completion, an average of 1 year
measure: blister skin immunochemistry and immunofluorescence analysis
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: CK levels
timeFrame: through hospitalization completion, an average of 1 month
measure: chloride levels
timeFrame: through hospitalization completion, an average of 1 month
measure: UREA levels
timeFrame: through hospitalization completion, an average of 1 month
Other outcomes:
measure: LKS score
timeFrame: through study completion, an average of 1 year
measure: VAS scores
timeFrame: through study completion, an average of 1 year
Locations:
city: Shijiazhuang
country: China
facility: the Third Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: Hebei Medical University Third Hospital
name: Hou Zhiyong, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.