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NCT Number: NCT04529330

The Research About 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.

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Key information

Conditions

Acute Compartment Syndrome Fractures, Bone Knee Fractures Knee Injuries Leg Injuries Tibial Fractures Tibial Plateau Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

the Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location status: Recruiting

Location contact

Chen Wei

CONTACT

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fasciotomy

Procedure

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 outcomes

  1. injury mechanism

    Time frame: up to 1 weeks

    The relative data was collected about injury mechanism such as high falling accident, traffic accident, fall from standing height,Crushing

  2. the time when the blister appeared

    Time frame: up to 4 weeks

    The relative data was collected about the time when the blister appeared after injury

  3. time to reconstructive surgery

    Time frame: time to when the surgery was conducted after 2 weeks

    The relative data was collected about time to reconstructive surgery

  4. union time

    Time frame: through study completion, an average of 1 year

    The relative data was collected about union time

  5. No non-anatomic gap or step (larger than 5 mm)

    Time frame: through study completion, an average of 1 year

    The relative data was collected about complications

  6. secondary loss of reduction

    Time frame: through study completion, an average of 1 year

    The relative data was collected about complications

  7. Deep venous thrombosis

    Time frame: through study completion, an average of 1 year

    The relative data was collected about complications

  8. superficial wound problems

    Time frame: through study completion, an average of 1 year

    The relative data was collected about complications

  9. blister skin immunochemistry and immunofluorescence analysis

    Time frame: 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.

Secondary outcomes

  1. CK levels

    Time frame: through hospitalization completion, an average of 1 month

    CK levels

  2. chloride levels

    Time frame: through hospitalization completion, an average of 1 month

    chloride levels

  3. UREA levels

    Time frame: through hospitalization completion, an average of 1 month

    UREA levels

Other outcomes

  1. LKS score

    Time frame: through study completion, an average of 1 year

    Lysholm knee score

  2. VAS scores

    Time frame: through study completion, an average of 1 year

    visual analogue scale

Study contacts

Contact information is provided by the study sponsor or research team.

Guo Jialiang, Doctor

CONTACT

[email protected]

18203222090

Ma Lijie, Doctor

CONTACT

Sponsors and collaborators

Lead sponsor

Hebei Medical University Third Hospital

Other

Registry information

Official study title

Acute Compartment Syndrome

Important dates

Study start
2019
Primary completion
2022
Study completion
2030
First posted
Aug 27, 2020
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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