NCT04425369

Brief Summary

The iliac crest is one of the most commonly used bone graft sources, especially in pediatric pelvic osteotomy operations for developmental dysplasia of the hip (DDH) and Legg-Calve-Perthes disease. In this study, we aimed to identify the effects of inner side and two-sided approaches for iliac crest bone harvesting on post-surgery ilium growth in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

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
5 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

5 years

First QC Date

June 6, 2020

Last Update Submit

June 9, 2020

Conditions

Keywords

pelvic osteotomydevelopmental dysplasia of the hipiliac crest bone graft

Outcome Measures

Primary Outcomes (2)

  • Radiographic parameters were evaluated on anteroposterior pelvic radiographs

    The growth areas were measured by GE healthcare-Centricity RIS CE V3.0 software (General Electric Company). The areas was calculated as mm2.

    3th month after surgery

  • Time for the totally recovery of iliac defect

    the time was calculated from the surgery to the time totally recovery of iliac defect by days

    through study completion, an average of 6 months

Study Arms (2)

inner side approaches for iliac crest bone graft

NO INTERVENTION

An anterior approach was used to expose the inner table of the ilium.

two-sided approaches for iliac crest bone graft

EXPERIMENTAL

both sides of the ilium were totally exposed of the ilium.

Procedure: two-sided approaches for iliac crest bone graft

Interventions

Only one side of the ilium was exposed when surgery.

two-sided approaches for iliac crest bone graft

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • the patients who performed iliac crest bone graft and pelvic osteotomy at the same time

You may not qualify if:

  • they had a history of pelvic osteotomy or iliac crest bone graft surgery, bilateral hip disease or congenital bone dysplasia, or were lost to 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

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Hip DislocationJoint DislocationsJoint DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice professor

Study Record Dates

First Submitted

June 6, 2020

First Posted

June 11, 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