NCT04007016

Brief Summary

Developmental dysplasia of the hip (DDH) was one of the most common hip disorders disease in children. Pemberton osteotomy (PO) was one of the most widely used by the pediatric orthopedic surgeons. In our clinical work, the investigators found some defect the operation procedure. When the surgeons were not familiar to the PO, it may injured the triradiate cartilage or easily be absorbable of the distal iliac. Here, the investigators found a new pelvic osteotomy just from the inner "L shaped" iliac osteotomy (ILSO) to treat DDH. This approach was in a visible part of the sciatic notch and not presumed to be in the ischium, completely out of sight. Comparing to the PO method, the investigators' operation method was easy to master and had less complications.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

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

March 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

2.2 years

First QC Date

June 28, 2019

Last Update Submit

July 1, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • preoperative acetabular index

    preoperative acetabular index by measure the postoperative X-ray

    6th month after surgery

  • Wiberg's mean center-edge angle

    center-edge angle by measure the postoperative X-ray

    6th month after surgery

Secondary Outcomes (2)

  • blood loss

    1st day after surgery

  • avascular necrosis (AVN)

    through study completion, an average of 1 year

Study Arms (2)

Pemberton osteotomy (PO)

PO group received Pemberton osteotomy

inner "L shaped" iliac osteotomy (ILSO)

ILSO group received inner "L shaped" iliac osteotomy

Procedure: a new osteotomy from the inner "L shaped" iliac osteotomy

Interventions

There were two ostectomies were used in the osteotomy. The first was was a cured and 5mm width and the second one was straight 1.5cm width. All the directions was started from the inner to outer just a bove the triradiate cartilage and its shape like"L"

inner "L shaped" iliac osteotomy (ILSO)

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All patients were evaluated and treated in the same hospital and the same surgeon did all the operation. The study was carried out between Mar 2016 and May 2018.

You may qualify if:

  • over two years old
  • open reduction and acetabular osteotomy
  • diagnosed as developmental dysplasia of the hip

You may not qualify if:

  • a previous history of DDH surgery
  • teratologic dislocations
  • cerebral palsy
  • other spastic or neuromuscular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice Professor of Pediatric orthopedic

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 5, 2019

Study Start

March 1, 2016

Primary Completion

May 1, 2018

Study Completion

June 1, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07