NCT03112447

Brief Summary

To compare surgical outcomes from medial epicondyle fracture fixation with absorbable cartilage nails to those from traditional Kirschner wire fixation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

5 years

First QC Date

March 6, 2017

Last Update Submit

April 12, 2017

Conditions

Fracture Arm

Keywords

medial epicondyle humerusabsorbable cartilage nail

Outcome Measures

Primary Outcomes (4)

  • Pain Intensity

    Pain Intensity assessed with the Bede Scoring System

    on 12th month

  • Elbow Motion

    Elbow Motion assessed in degrees

    on 12th month

  • Stability

    Stability assessed using the following scoring system: Stable, Moderate Instability, Grossly Unstable.

    on 12th month

  • Elbow Function evaluation

    A specific physician check the patients and ask them to perform the following activity.(comb hair,eat;perform hygiene;don shirt;don shoe)

    on 12th month

Study Arms (2)

absorbable cartilage nail Group

EXPERIMENTAL

10 males and 7 females, ages 7-15 years (average, 11.8), and 3 patients with elbow dislocation, the fractures were fixed by absorbable cartilage nail

Procedure: absorbable cartilage nail

traditional Kirschner wire Group

ACTIVE COMPARATOR

10 males and 5 females, ages 8-14 years (average, 12.6), and 4 patients with elbow dislocation, the fractures were fixed by traditional Kirschner wires

Procedure: traditional Kirschner wires

Interventions

absorbable cartilage nailPROCEDURE

The experiment group patients were fixed with absorbable cartilage nails

absorbable cartilage nail Group
traditional Kirschner wiresPROCEDURE

The control group were fixed with traditional Kirschner wires

traditional Kirschner wire Group

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • fractures with more than 2 mm of displacement were treated with cast immobilization

You may not qualify if:

  • fractures with less than 2 mm of displacement were treated with cast immobilization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of Department orthopeadic department

Study Record Dates

First Submitted

March 6, 2017

First Posted

April 13, 2017

Study Start

August 1, 2007

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

April 13, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share