NCT04424498

Brief Summary

This study aimed to evaluate the outcomes of using absorbable rods and Kirschner Wires technique for severe displaced radial neck fractures combined with olecranon fractures in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

June 5, 2020

Last Update Submit

June 9, 2020

Conditions

Child

Keywords

Kirschner wiresAbsorbable rodsRadial neck fractureOlecranon fracture

Outcome Measures

Primary Outcomes (1)

  • Mayo Elbow Performance Index score

    MEPI results were categorized as follows: \>90 points, excellent; 81-90 points, good; 61-80 points, fair; and \<60 points, poor.

    3th month after surgery

Interventions

Absorbable Rods and Kirschner WiresPROCEDURE

A Boyd incision was applied in all patients; olecranon fractures were reduced first and fixed with Kirschner wires. Then, the displaced radial neck fractures were reduced and fixed using absorbable rods.

Eligibility Criteria

Age3 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Medical records of patients who attended our hospital between Jan 2012 and Dec 2016 were retrospectively reviewed.

You may qualify if:

  • open reduction of severe radial neck fractures combined with an olecranon fractures in the same elbow
  • fixation performed using absorbable rods and K-wires

You may not qualify if:

  • single radial head fractures or single olecranon fractures
  • fixation performed with bands
  • old fractures,
  • Boyd incision was not used,
  • guardians did not agree with the surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

Location

MeSH Terms

Conditions

Radial Head and Neck FracturesOlecranon Fracture

Interventions

Bone Wires

Condition Hierarchy (Ancestors)

Elbow FracturesElbow InjuriesArm InjuriesWounds and InjuriesRadius FracturesForearm InjuriesFractures, BoneUlna Fractures

Intervention Hierarchy (Ancestors)

Internal FixatorsProstheses and ImplantsEquipment and SuppliesOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentSurgical Fixation Devices

Study Officials

  • Yuxi Su, M.D.

    Children's hospital of Chongqing Medical Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice professor

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 11, 2020

Study Start

June 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)