Risk Factors for Post-Operative Nonunion of Tibial Shaft Fractures Based on a Path Analysis Model
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03928912 Completed April 26, 2019 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
Estimated Enrollment : 234 participants
Intervention Model : N/A
Masking: N/A
Primary Purpose: N/A
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
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
Investigator
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     
Other Study ID Numbers : I2019001035
First Posted : April 26, 2019
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