ChildNCT04425369
Iliac Crest Bone Graft Harvesting for Pediatric Pelvic Osteotomy
A study testing two-sided approaches for iliac crest bone graft in people with Child and Osteotomy, run by Yuxi Su at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- What is being tested?
- two-sided approaches for iliac crest bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- the patients who performed iliac crest bone graft and pelvic osteotomy at the same time
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
About this study
Official title: Comparison of the Inner Side and Two-sided Approaches for Iliac Crest Bone Graft Harvesting for Pediatric Pelvic Osteotomy
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.
- Being tested
- two-sided approaches for iliac crest bone graft
- Keywords
- pelvic osteotomy, developmental dysplasia of the hip, iliac crest bone graft
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two-sided approaches for iliac crest bone graftProcedure or surgery
Only one side of the ilium was exposed when surgery.
| Study group | Role | What they receive |
|---|---|---|
| inner side approaches for iliac crest bone graft | No intervention | An anterior approach was used to expose the inner table of the ilium. |
| two-sided approaches for iliac crest bone graft | Experimental | both sides of the ilium were totally exposed of the ilium. Receives: Procedure: two-sided approaches for iliac crest bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3th month after surgery
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
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jan 2015
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuxi Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuxi Su, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425369
- Sponsor's protocol ID
- CQMU20200017
- Status last verified
- Jun 2020
- First submitted
- 6 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Inner Side and Two-sided Approaches for Iliac Crest Bone Graft Harvesting for Pediatric Pelvic Osteotomy
- ClinicalTrials.gov ID
- NCT04425369
- Acronym / sponsor ID
- CQMU20200017
- Keywords
- pelvic osteotomy, developmental dysplasia of the hip, iliac crest bone graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Yuxi SuUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inner side approaches for iliac crest bone graft | No intervention | –An anterior approach was used to expose the inner table of the ilium. |
| two-sided approaches for iliac crest bone graft | Experimental | Procedure: two-sided approaches for iliac crest bone graftboth sides of the ilium were totally exposed of the ilium. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- the patients who performed iliac crest bone graft and pelvic osteotomy at the same time
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| two-sided approaches for iliac crest bone graftOnly one side of the ilium was exposed when surgery. | Procedure or surgery | two-sided approaches for iliac crest bone graft |
Primary outcome
Radiographic parameters were evaluated on anteroposterior pelvic radiographs
Time frame: 3th month after surgery
The growth areas were measured by GE healthcare-Centricity RIS CE V3.0 software (General Electric Company). The areas was calculated as mm2.
Time for the totally recovery of iliac defect
Time frame: through study completion, an average of 6 months
the time was calculated from the surgery to the time totally recovery of iliac defect by days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing two-sided approaches for iliac crest bone graft in people with Child and Osteotomy, run by Yuxi Su at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic parameters were evaluated on anteroposterior pelvic radiographs (time frame: 3th month after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.