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RecruitingNCT04529330Updated Aug 4, 2021

The Research About Acute Compartment Syndrome

An observational study in Acute Compartment Syndrome, sponsored by Hebei Medical University Third Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-04.

Sponsored by Hebei Medical University Third Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2022, 4 years 2 months ago, but the record still lists the study as recruiting.
  • Started Jan 2019; still recruiting 7 years 10 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Compartment Syndrome

Keywords

  • ACS
  • Tibial plateau fractures
  • Tibial shaft fractures
03

In context

Tibial Plateau Fractures

32 studies on the registry are indexed under Tibial Plateau Fractures; 12 are open to participants now.

Browse Tibial Plateau Fractures studies →

Lead sponsor

Hebei Medical University Third Hospital is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Fracture patients with Schatzker V and VI,
  • Who were older than eighteen years.

Exclusion criteria

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • fractures with blister appeared

    tibial plateau fractures with blister observed

    Procedure: fasciotomy

  • fractures without blister appeared

    tibial plateau fractures without blister observed

    Procedure: fasciotomy

Interventions

  • Procedurefasciotomy

    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

06

What researchers measure

Primary outcomes

  1. injury mechanism

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

    Time frame: up to 1 weeks

  2. the time when the blister appeared

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

    Time frame: up to 4 weeks

  3. time to reconstructive surgery

    The relative data was collected about time to reconstructive surgery

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

  4. union time

    The relative data was collected about union time

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

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

    The relative data was collected about complications

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

  6. secondary loss of reduction

    The relative data was collected about complications

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

  7. Deep venous thrombosis

    The relative data was collected about complications

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

  8. superficial wound problems

    The relative data was collected about complications

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

  9. 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.

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

Secondary outcomes

  1. CK levels

    CK levels

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

  2. chloride levels

    chloride levels

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

  3. UREA levels

    UREA levels

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

Other outcomes

  1. LKS score

    Lysholm knee score

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

  2. VAS scores

    visual analogue scale

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 31277147 ↗

Individual participant data

Plan to share: Yes — acute compartment syndrome

Supporting information: Study protocol

Time frame: 2 years after the experiment was conducted

Access criteria: all authors focusing on ACS research

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2019 (actual). Primary completion is estimated for Sep 2022, 44 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2020
First posted
Aug 27, 2020
StartActual
Jan 1, 2019
Primary completionEst.
Sep 9, 2022
CompletionEst.
Dec 31, 2030
Last update
Aug 4, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04529330
Lead sponsor
Hebei Medical University Third Hospital
Responsible party
Sponsor
First posted
Aug 27, 2020
Start date
Jan 1, 2019
Primary completion
Sep 9, 2022 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Aug 4, 2021

Study contacts

Guo Jialiang, Doctor
Contact
drjlguo86@gmail.com
18203222090
Ma Lijie, Doctor
Contact
Hou Zhiyong, Doctor
principal investigator · Hebei Medical University Third Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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