NCT04529330

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
57mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Jan 2019Dec 2030

Study Start

First participant enrolled

January 1, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2022

Completed
8.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

August 4, 2021

Status Verified

July 1, 2021

Enrollment Period

3.7 years

First QC Date

August 19, 2020

Last Update Submit

July 28, 2021

Conditions

Keywords

ACSTibial plateau fracturesTibial shaft fractures

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (3)

  • CK levels

    through hospitalization completion, an average of 1 month

  • chloride levels

    through hospitalization completion, an average of 1 month

  • UREA levels

    through hospitalization completion, an average of 1 month

Other Outcomes (2)

  • LKS score

    through study completion, an average of 1 year

  • VAS scores

    through study completion, an average of 1 year

Study Arms (2)

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

fasciotomyPROCEDURE

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 with blister appearedfractures without blister appeared

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • Patients who was eighteen years or younger.
  • Patients treated with other implant,
  • underwent conservative management were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 31277147BACKGROUND
  • Wang T, Yang S, Guo J, Long Y, Hou Z. Predictors of muscle necrosis in patients with acute compartment syndrome. Int Orthop. 2023 Apr;47(4):905-913. doi: 10.1007/s00264-023-05699-9. Epub 2023 Jan 30.

MeSH Terms

Conditions

Tibial Plateau Fractures

Interventions

Fasciotomy

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and InjuriesTibial FracturesKnee InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Hou Zhiyong, Doctor

    Hebei Medical University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guo Jialiang, Doctor

CONTACT

Ma Lijie, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2020

First Posted

August 27, 2020

Study Start

January 1, 2019

Primary Completion

September 9, 2022

Study Completion (Estimated)

December 31, 2030

Last Updated

August 4, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

acute compartment syndrome

Shared Documents
STUDY PROTOCOL
Time Frame
2 years after the experiment was conducted
Access Criteria
all authors focusing on ACS research

Locations