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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04425369
Other study ID # CQMU20200017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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