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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03928912

Recruitment Status Completed

First Posted April 26, 2019

Last update posted April 26, 2019

Study Description

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)
  • Intervention/Treatment:
  • Phase: N/A
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.

Study Design
  • 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 2019
  • Actual Primary Completion Date: April 2019
  • Actual Study Completion Date: April 2019
Outcome Measures
  • 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.
Eligibility Criteria
  • 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.

Contacts and Locations
Contacts
Locations

China, Zhejiang
Institutional Review Board of The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Study Chair: Jian'an Wang, Ph.D Zhejiang University

More Information
  • 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
  • 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: Fractures, Bone
    Fractures, Ununited
    Tibial Fractures