Iliac Crest Bone Graft Harvesting for Pediatric Pelvic Osteotomy

Child Clinical Trial

Official title:

Comparison of the Inner Side and Two-sided Approaches for Iliac Crest Bone Graft Harvesting for Pediatric Pelvic Osteotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04425369
• Other study ID #: CQMU20200017
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: January 1, 2020

Study information

• Verified date: June 2020
• Source: Children's Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

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

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.

Related Conditions & MeSH terms

• Child
• Osteotomy

Intervention

Procedure:
• two-sided approaches for iliac crest bone graft
Only one side of the ilium was exposed when surgery.

Locations

Country	Name	City	State
China	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Yuxi Su

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3th month after surgery
Primary	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	through study completion, an average of 6 months