NCT04423835

Brief Summary

Humeral osteotomy is the most effective method for evident cubitus varus correction in children. Several osteotomy methods and fixation materials have been developed in the past. By applying the principles of deformity correction described by Paley, the investigators describe a novel corrective technique for cubitus varus involving lateral osteotomy using Kirschner wires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 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

January 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

5 years

First QC Date

June 6, 2020

Last Update Submit

June 8, 2020

Conditions

Keywords

cubitus varussupracondylar humerus fractureosteotomy

Outcome Measures

Primary Outcomes (1)

  • Elbow appearance

    elbows were evaluated using radiography and appearence

    3th month after surgery

Study Arms (1)

lateral closing osteotomy for cubitus varus deformity

The osteotomy line of all patients was designed according to Paley's principles. The lateral incision was applied in all patients and the osteotomy lines were marked on the humerus with the assistance of C-arm radiographs.

Procedure: Paley's Principle osteotomy

Interventions

. The osteotomy line of all patients was designed according to Paley's principles. The lateral incision was applied in all patients and the osteotomy lines were marked on the humerus with the assistance of C-arm radiographs. An isosceles triangle template was used for osteotomy, and the medial cortex was left intact. K-wires were used to fix the osteotomy laterally.

Also known as: Applying Paley's Principles to Lateral Closing Wedge Osteotomy
lateral closing osteotomy for cubitus varus deformity

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All the patients were performed surgery between July 2015 and October 2017

You may qualify if:

  • surgery performed over 6 months after the occurrence of SHFs
  • difference in flexion angles of the affected and unaffected limbs of \>15 degrees
  • recovery of elbow function pre-ostomy

You may not qualify if:

  • any other surgical approach used
  • consent not obtained from the patient's guardians
  • incomplete follow-up

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

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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 6, 2020

First Posted

June 9, 2020

Study Start

January 1, 2015

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations