ClinicalTrials.gg
CompletedNCT04007016Updated Jul 5, 2019

A New Pelvic Osteotomy Method for Open Reduction

An observational study in Developmental Dysplasia of the Hip, sponsored by Yuxi Su. Completed. Open to participants aged 2 Years to 8 Years. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Yuxi Su · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2
Ages
2 Years to 8 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Developmental Dysplasia of the Hip
03

In context

Developmental Dysplasia of the Hip

60 studies on the registry are indexed under Developmental Dysplasia of the Hip; 18 are open to participants now.

This study's enrollment of 2 is below the median of 72 across 21 observational studies indexed under Developmental Dysplasia of the Hip.

Browse Developmental Dysplasia of the Hip studies →

Lead sponsor

Yuxi Su is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • a previous history of DDH surgery
  • teratologic dislocations
  • cerebral palsy
  • other spastic or neuromuscular disease
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Procedurea 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"

06

What researchers measure

Primary outcomes

  1. preoperative acetabular index

    preoperative acetabular index by measure the postoperative X-ray

    Time frame: 6th month after surgery

  2. Wiberg's mean center-edge angle

    center-edge angle by measure the postoperative X-ray

    Time frame: 6th month after surgery

Secondary outcomes

  1. blood loss

    blood loss during surgery

    Time frame: 1st day after surgery

  2. avascular necrosis (AVN)

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

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2016 to primary completion in May 2018, 26 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 28, 2019
First posted
Jul 5, 2019
StartActual
Mar 1, 2016
Primary completionActual
May 1, 2018
CompletionActual
Jun 1, 2019
Last update
Jul 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04007016
Lead sponsor
Yuxi Su
Responsible party
Yuxi Su (Vice Professor of Pediatric orthopedic, Children's Hospital of Chongqing Medical University) — Sponsor-investigator
First posted
Jul 5, 2019
Start date
Mar 1, 2016
Primary completion
May 1, 2018
Completion
Jun 1, 2019
Last update
Jul 5, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion