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Risk Factors for Post-Operative Nonunion of Tibial Shaft Fractures Based on a Path Analysis Model

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ClinicalTrials.gov Identifier: NCT03928912
Recruitment Status : Completed
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
Tibial shaft fractures is common long tubular fracture that account for about 13.7% of all fractures. And the incidence of nonunion of tibial shaft fracture varied from 1% to 80%. This study aimed to confirm the risk factors of nonunion of tibial shaft fracture. Moreover, the investigators hope to establish the clinical pathway of various risk factors for fracture nonunion and affirm the importance of different risk factors.

Condition or disease
Nonunion of Fracture of Tibia (Diagnosis)

Detailed Description:
Tibial shaft fractures is common long tubular fracture that account for about 13.7% of all fractures. And the incidence of nonunion of tibial shaft fracture varied from 1% to 80%. The investigators retrospectively analyzed the demographics of these participants in our hospital that occur long tubular fracture. One group is participants that existed fracture nonunion. And the other group is the participants that did not exist fracture nonunion. The investigators recorded twelve variables and confirm the risk factors by uni-variate Logistic regression analysis. Moreover, the investigators hope to establish the clinical pathway of various risk factors for fracture nonunion and affirm the importance of different risk factors.

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Study Type : Observational
Actual Enrollment : 234 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Risk Factors for Post-Operative Nonunion of Tibial Shaft Fractures Based on a Path Analysis Model: A Case-Control Study
Actual Study Start Date : February 2, 2019
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort
without fracture nonunion
The patients who undergone surgery after tibial shaft fracture did not exist fracture nonunion
with fracture nonunion
The patients who undergone surgery after tibial shaft fracture existed fracture nonunion



Primary Outcome Measures :
  1. the Gustilo type of the open fracture [ Time Frame: the outcome of the Gustilo type can acquire within 1 week. ]
    the Gustilo type of the open fracture can be divided into three types. And the type I is the open fractures with wounds that is clean and smaller than 1cm. Type II is the the open fractures with wounds that is moderately unclean and bigger than 1cm, which also has a wide soft tissue injury. Type III is the all open fractures that accompany with severe soft tissue injury and pollution.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The population came from The Second Affiliated Hospital of Zhejiang University.
Criteria

Inclusion Criteria:

  • The tibial shaft fracture was caused by trauma.

Exclusion Criteria:

  • The tibial shaft fracture was caused by tumor, infection and other reasons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928912


Locations
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China, Zhejiang
Institutional Review Board of The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Chair: Jian'an Wang, Ph.D Zhejiang University

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03928912     History of Changes
Other Study ID Numbers: I2019001035
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
nonunion
tibial shaft fracture
path analysis model
Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Ununited
Tibial Fractures
Wounds and Injuries
Leg Injuries