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

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ClinicalTrials.gov Identifier: NCT02773511
Recruitment Status : Unknown
Verified May 2016 by Li Jin, Wuhan Union Hospital, China.
Recruitment status was:  Not yet recruiting
First Posted : May 16, 2016
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Li Jin, Wuhan Union Hospital, China

Study Description
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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

Condition or disease Intervention/treatment Phase
Treatment for Type I Humeral Condyle Fracture Procedure: Surgical treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2016
Estimated Primary Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
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Arm Intervention/treatment
Bone healing
Bone healing in surgical or conservative treatment for children type 1 humeral condyle fracture
 Procedure: Surgical treatment
Closed reduction and Kirschner wire fixation
Fracture displacement
Fracture displacement in surgical or conservative treatment for children type 1 humeral condyle fracture
 Procedure: Surgical treatment
Closed reduction and Kirschner wire fixation


Outcome Measures
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Primary Outcome Measures :
  1. Fracture displacement rate [ Time Frame: 1 months ]
  2. Fracture healing rate [ Time Frame: 3 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Other type humeral Condyle Fracture

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Li Jin, Wuhan Union Hospital, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT02773511    
Other Study ID Numbers: WuhanUH
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries