Multi-center Study on Surgical or Non-surgical Treatment for Children Type 1 Humeral Condyle Fracture

Treatment for Type I Humeral Condyle Fracture Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02773511
• Other study ID #: WuhanUH
• Status: Not yet recruiting
• Phase: N/A
• First received: May 13, 2016
• Last updated: May 13, 2016
• Start date: July 2016

Study information

• Verified date: May 2016
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chinese: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study evaluates the effectiveness of surgical or non-surgical treatment for children type 1 humeral condyle fracture.Half of the participants receive surgical treatment and the other half receive non-surgical treatment

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 14 Years

Eligibility

Inclusion Criteria:

Children Type 1 humeral Condyle Fracture,Fracture displacement less than 2mm

Exclusion Criteria:

Other type humeral Condyle Fracture

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Treatment for Type I Humeral Condyle Fracture

Intervention

Procedure:
• Surgical treatment
Closed reduction and Kirschner wire fixation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fracture displacement rate		1 months	Yes
Primary	Fracture healing rate		3 years	Yes