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

Nonunion of Fracture of Tibia (Diagnosis) Clinical Trial

Official title:

Risk Factors for Post-Operative Nonunion of Tibial Shaft Fractures Based on a Path Analysis Model: A Case-Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03928912
• Other study ID #: I2019001035
• Status: Completed
• Start date: February 2, 2019
• Est. completion date: April 10, 2019

Study information

• Verified date: April 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: April 10, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The tibial shaft fracture was caused by trauma.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Ununited
• Nonunion of Fracture of Tibia (Diagnosis)
• Tibial Fractures

Locations

Country	Name	City	State
China	Institutional Review Board of The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Gustilo type of the open fracture	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.	the outcome of the Gustilo type can acquire within 1 week.