A New Pelvic Osteotomy Method for Open Reduction

Developmental Dysplasia of the Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04007016
• Other study ID #: Yuxi-Guoxin 201906
• Status: Completed
• Start date: March 1, 2016
• Est. completion date: June 1, 2019

Study information

• Verified date: July 2019
• Source: Children's Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 1, 2019
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Developmental Dysplasia of the Hip
• Hip Dislocation, Congenital

Intervention

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"

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yuxi Su

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preoperative acetabular index	preoperative acetabular index by measure the postoperative X-ray	6th month after surgery
Primary	Wiberg's mean center-edge angle	center-edge angle by measure the postoperative X-ray	6th month after surgery
Secondary	blood loss	blood loss during surgery	1st day after surgery
Secondary	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