ClinicalTrials.gg
CompletedNCT04425369Updated Jun 11, 2020

Iliac Crest Bone Graft Harvesting for Pediatric Pelvic Osteotomy

An interventional study of two-sided approaches for iliac crest bone graft in Child and Osteotomy, sponsored by Yuxi Su. Completed at 1 site in China. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-06-11.

Sponsored by Yuxi Su · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 5 months after the study started (first participant enrolled Jan 2015, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Non-randomized
Ages
2 Years to 16 Years
Sex
All
01

Study summary

The iliac crest is one of the most commonly used bone graft sources, especially in pediatric pelvic osteotomy operations for developmental dysplasia of the hip (DDH) and Legg-Calve-Perthes disease. In this study, we aimed to identify the effects of inner side and two-sided approaches for iliac crest bone harvesting on post-surgery ilium growth in children.

Read the detailed description

Autogenous bone grafting is still the gold standard and most effective method for treatment of non-union and bone defects due to congenital disease and infection. Despite the development of bone engineering, none of the allogeneic bone products can match the osteoinductive, osteoconductive, and immunogenic properties of autogenous bone. The iliac crest is one of the most harvested sites other than the fibula, ribs, and ulna. An iliac crest bone graft (ICBG) can supply a larger amount of cortical and cancellous bone than grafts from other donor sites. Pelvic osteotomy is widely used for treating developmental dysplasia of the hip (DDH) and Legg-Calve-Perthes disease. Tricortical structural bone such as that in the ilium is needed to stabilize the pelvis after osteotomy, and the anterior and posterior iliac crest are the two most used graft donor sites. When surgery is planned in the prone position, such as that for posterior spinal fusion, surgeons generally prefer to adopt the posterior approach for ICBG procedures. In supine position surgeries such as pelvic osteotomy for DDH or Legg-Calve-Perthes disease, surgeons prefer the anterior approach for ICBG procedures. There are many studies on iliac bone growth and complications after ICBG procedures. Most of the studies demonstrated good outcomes and few complications. However, according to our literature review, none of the previous studies used the iliac bone for transplantation in pelvic osteotomy. In this study, we compared the results between an inner table harvest site and an inner-outer table harvest site for ICBG used to maintain stability in pelvic osteotomy.

02

Conditions studied

  • Child
  • Osteotomy

Keywords

  • pelvic osteotomy
  • developmental dysplasia of the hip
  • iliac crest bone graft
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 47 is below the median of 59 across 38 interventional 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 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • the patients who performed iliac crest bone graft and pelvic osteotomy at the same time

Exclusion criteria

Exclusion Criteria:

  • they had a history of pelvic osteotomy or iliac crest bone graft surgery, bilateral hip disease or congenital bone dysplasia, or were lost to follow-up.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
47 participants (actual)

Study arms

  • No intervention
    inner side approaches for iliac crest bone graft

    An anterior approach was used to expose the inner table of the ilium.

  • Experimental
    two-sided approaches for iliac crest bone graft

    both sides of the ilium were totally exposed of the ilium.

    Procedure: two-sided approaches for iliac crest bone graft

Interventions

  • Proceduretwo-sided approaches for iliac crest bone graft

    Only one side of the ilium was exposed when surgery.

06

What researchers measure

Primary outcomes

  1. Radiographic parameters were evaluated on anteroposterior pelvic radiographs

    The growth areas were measured by GE healthcare-Centricity RIS CE V3.0 software (General Electric Company). The areas was calculated as mm2.

    Time frame: 3th month after surgery

  2. Time for the totally recovery of iliac defect

    the time was calculated from the surgery to the time totally recovery of iliac defect by days

    Time frame: through study completion, an average of 6 months

07

Study locations

1 site
  • Children's Hospital of Chongqing Medical University
    Chongqing, Chongqing 400014, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04425369
Lead sponsor
Yuxi Su
Responsible party
Yuxi Su (Vice professor, Children's Hospital of Chongqing Medical University) — Sponsor-investigator
First posted
Jun 11, 2020
Start date
Jan 1, 2015
Primary completion
Jan 1, 2020
Completion
Jan 1, 2020
Last update
Jun 11, 2020

Oversight

Data monitoring committee
No
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 Jun 2020. 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