NCT02773511

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

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Last Updated

May 16, 2016

Status Verified

May 1, 2016

Enrollment Period

3 years

First QC Date

May 13, 2016

Last Update Submit

May 13, 2016

Conditions

Treatment for Type I Humeral Condyle Fracture

Outcome Measures

Primary Outcomes (2)

  • Fracture displacement rate

    1 months

  • Fracture healing rate

    3 years

Study Arms (2)

Bone healing

OTHER

Bone healing in surgical or conservative treatment for children type 1 humeral condyle fracture

Procedure: Surgical treatment

Fracture displacement

OTHER

Fracture displacement in surgical or conservative treatment for children type 1 humeral condyle fracture

Procedure: Surgical treatment

Interventions

Surgical treatmentPROCEDURE

Closed reduction and Kirschner wire fixation

Bone healingFracture displacement

Eligibility Criteria

AgeUp to 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Other type humeral Condyle Fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wuhan Union Hospital

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 16, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2019

Last Updated

May 16, 2016

Record last verified: 2016-05