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Completed

NCT Number: NCT04007016

A New Pelvic Osteotomy Method for Open Reduction

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.

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Key information

Conditions

Developmental Dysplasia of the Hip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hip Dislocation Joint Diseases Joint Dislocations Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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"

Primary outcomes

  1. preoperative acetabular index

    Time frame: 6th month after surgery

    preoperative acetabular index by measure the postoperative X-ray

  2. Wiberg's mean center-edge angle

    Time frame: 6th month after surgery

    center-edge angle by measure the postoperative X-ray

Secondary outcomes

  1. blood loss

    Time frame: 1st day after surgery

    blood loss during surgery

  2. avascular necrosis (AVN)

    Time frame: through study completion, an average of 1 year

    avascular necrosis (AVN) of the femoral head according to the Kalamchi and McEwen classification

Sponsors and collaborators

Lead sponsor

Yuxi Su

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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