Back to resultsMulti-center Study on Surgical or Non-surgical Treatment for Children Type 1 Humeral Condyle Fracture
Primary Purpose
Treatment for Type I Humeral Condyle Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Surgical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Treatment for Type I Humeral Condyle Fracture
Eligibility Criteria
Inclusion Criteria:
Children Type 1 humeral Condyle Fracture，Fracture displacement less than 2mm
Exclusion Criteria:
Other type humeral Condyle Fracture
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Bone healing
Fracture displacement
Arm Description
Bone healing in surgical or conservative treatment for children type 1 humeral condyle fracture
Fracture displacement in surgical or conservative treatment for children type 1 humeral condyle fracture
Outcomes
Primary Outcome Measures
Fracture displacement rate
Fracture healing rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02773511
Brief Title
Multi-center Study on Surgical or Non-surgical Treatment for Children Type 1 Humeral Condyle Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment for Type I Humeral Condyle Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bone healing
Arm Type
Other
Arm Description
Bone healing in surgical or conservative treatment for children type 1 humeral condyle fracture
Arm Title
Fracture displacement
Arm Type
Other
Arm Description
Fracture displacement in surgical or conservative treatment for children type 1 humeral condyle fracture
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment
Intervention Description
Closed reduction and Kirschner wire fixation
Primary Outcome Measure Information:
Title
Fracture displacement rate
Time Frame
1 months
Title
Fracture healing rate
Time Frame
3 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children Type 1 humeral Condyle Fracture，Fracture displacement less than 2mm
Exclusion Criteria:
Other type humeral Condyle Fracture
12. IPD Sharing Statement
Learn more about this trial
Multi-center Study on Surgical or Non-surgical Treatment for Children Type 1 Humeral Condyle Fracture
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