A New Pelvic Osteotomy Method for Open Reduction

A New Pelvic Osteotomy Method for Open Reduction in the Treatment of Developmental Dysplasia of the Hip in Children

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.

Study Overview

• Status: Completed
• Conditions: Developmental Dysplasia of the Hip
• Intervention / Treatment: Procedure: a new osteotomy from the inner "L shaped" iliac osteotomy

• Study Type: Observational
• Enrollment (Actual): 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood loss	blood loss during surgery	1st day after surgery
avascular necrosis (AVN)	avascular necrosis (AVN) of the femoral head according to the Kalamchi and McEwen classification	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Yuxi Su

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Joint Dislocations; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: Yuxi-Guoxin 201906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No