Congenital HemivertebraNCT04527406
Early Surgical Intervention of Congenital Hemivertebra in Young Children
A study testing posterior hemivertebra resection and conservative treatment+ delayed posterior hemivertebra resection in people with Congenital Hemivertebra, run by Children's Hospital of Fudan University.
Trial summary
Early treatment of congenital hemivertebrae is very important. The investigators design this study to figure out how early hemivertebrae resection be apply to children. Children aged 3-5 years old diagnosed as congenital hemivertebrae will be randomly divided into early operation group and control group. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Congenital Hemivertebra
- What is being tested?
- posterior hemivertebra resection and conservative treatment+ delayed posterior hemivertebra resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 30 Dec 2028
- 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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Single-segment thoracic or lumbar hemivertebrae scoliosis diagnosed by X-ray and CT.
Who cannot join
- Diagnosed with syndrome of scoliosis, osteochondrodysplasia, multi-segment hemivertebrae deformity, cervical hemivertebrae deformity
About this study
Official title: Early Hemivertebra Resection of Congenital Hemivertebra in Very Young Children: A Randomized Clinical Study
Early treatment of congenital hemivertebrae is very important. The investigators design this study to figure out how early hemivertebrae resection be apply to children. Children aged 3-5 years old diagnosed as congenital hemivertebrae will be randomly divided into early operation group and control group. The early operation group will undergo posterior hemivertebra resection. The control group received brace plaster fixation to reduce the progression of scoliosis, and then will undergo operation after 5 years old. Primary Outcome Measure is the length of spine surgery.
Read the detailed description
Early diagnosis and early effective treatment of congenital hemivertebrae can correct the deformities.Therefore, traditionally, children with a clear diagnosis should be fixed with a brace to delay the aggravation of scoliosis and then undergo surgery after 5 years of age. The design of this study is to conduct a single-center randomized controlled study. Children aged 3-5 years old diagnosed as congenital hemivertebrae will be randomly divided into the early operation group and the control group. The early operation group will undergo posterior hemivertebra resection. The control group received brace plaster fixation to reduce the progression of scoliosis, and posterior scoliosis correction will be performed after the age was over 5 years old. The primary outcome measures are the length of spine surgery for the two groups of children. The secondary outcome measures are change of scoliosis cobb angle, by comparing preoperative and postoperative cobb angle changes. It is expected that the early treatment group will shorten the length of surgery due to the smaller degree of scoliosis. Our research is expected to broaden the age-adaptation of classic spinal surgery in the field of pediatric spine.
- Conditions
- Congenital Hemivertebra
- Being tested
- posterior hemivertebra resection, conservative treatment+ delayed posterior hemivertebra resection
- Keywords
- Congenital hemivertebra, Young Children, posterior hemivertebra resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior hemivertebra resectionProcedure or surgery
The subjects in early surgical group are arranged to be admitted to for surgical treatment very soon. The operation choice is posterior hemivertebrae resection + posterior pedicle screw placement + scoliosis correction. During operation pedicle screws are placed in the adjacent vertebrae of the head and tail of the Hemivertebra. Wedge resection of the hemivertebrae is performed afterward. Finally, two rods are placed between the pedicle screws. Intraoperative fluoroscopy confirms that the internal fixation position is good.
conservative treatment+ delayed posterior hemivertebra resectionProcedure or surgery
In traditional surgical group, subjects received conservative treatment firstly with custom-made braces to delay the progression of scoliosis. It is planned to use the classic posterior hemivertebrae resection + posterior pedicle screw placement + scoliosis correction to complete the correction around the age of 5. The operation choice is identical with early surgical group. During operation pedicle screws are placed in the adjacent vertebrae of the head and tail of the Hemivertebra. Wedge resection of the hemivertebrae is performed afterward. Finally, two rods are placed between the pedicle screws. Intraoperative fluoroscopy confirms that the internal fixation position is good.
| Study group | Role | What they receive |
|---|---|---|
| Early surgical group | Experimental | The subjects in this group received early surgical treatment, and they are arranged to be admitted to the hospital for surgical treatment after admission. The operation choice is posterior hemivertebrae resection + posterior pedicle screw placement + scoliosis correction. Receives: Procedure: posterior hemivertebra resection |
| Traditional surgical treatment | Active comparator | This group of subjects received conservative treatment with custom-made braces to delay the progression of scoliosis. It is planned to use the classic posterior hemivertebrae resection + posterior pedicle screw placement + scoliosis correction to complete the correction around the age of 5. Receives: Procedure: conservative treatment+ delayed posterior hemivertebra resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of surgery
The length of posterior hemivertebra resection operation time, acquired in the operation record from hospital
Measured: The operation time： from the beginning of the surgical skinning to the end of the surgical suture
Secondary outcomes (1)
change of scoliosis cobb angle
X-ray measurement of scoliosis cobb angle, by compare the preoperative and postoperative cobb angle changes to obtain the degree of scoliosis correction
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start1 Mar 2025 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital HemivertebraStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research subjects are randomly assigned to the early surgery group (experimental group) or traditional surgery group (control group) at a ratio of 1:1
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dahui Wang, MD-PhD, Principal investigator, Children's hospital of fudan uviversity, shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527406
- Sponsor's protocol ID
- HEMI 1.1
- Status last verified
- Mar 2026
- First submitted
- 24 Aug 2020
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: depend on correspond
Publications
Ginsburg G, Mulconrey DS, Browdy J. Transpedicular hemiepiphysiodesis and posterior instrumentation as a treatment for congenital scoliosis. J Pediatr Orthop. 2007 Jun;27(4):387-91. doi: 10.1097/01.bpb.0000271312.95621.b0.
PubMed 17513957
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Hemivertebra Resection of Congenital Hemivertebra in Very Young Children: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT04527406
- Acronym / sponsor ID
- HEMI 1.1
- Conditions
- Congenital Hemivertebra
- Keywords
- Congenital hemivertebra, Young Children, posterior hemivertebra resection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 26 Aug 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.
Early treatment of congenital hemivertebrae is very important. The investigators design this study to figure out how early hemivertebrae resection be apply to children. Children aged 3-5 years old diagnosed as congenital hemivertebrae will be randomly divided into early operation group and control group. The early operation group will undergo posterior hemivertebra resection. The control group received brace plaster fixation to reduce the progression of scoliosis, and then will undergo operation after 5 years old. Primary Outcome Measure is the length of spine surgery.
Detailed description
Early diagnosis and early effective treatment of congenital hemivertebrae can correct the deformities.Therefore, traditionally, children with a clear diagnosis should be fixed with a brace to delay the aggravation of scoliosis and then undergo surgery after 5 years of age. The design of this study is to conduct a single-center randomized controlled study. Children aged 3-5 years old diagnosed as congenital hemivertebrae will be randomly divided into the early operation group and the control group. The early operation group will undergo posterior hemivertebra resection. The control group received brace plaster fixation to reduce the progression of scoliosis, and posterior scoliosis correction will be performed after the age was over 5 years old. The primary outcome measures are the length of spine surgery for the two groups of children. The secondary outcome measures are change of scoliosis cobb angle, by comparing preoperative and postoperative cobb angle changes. It is expected that the early treatment group will shorten the length of surgery due to the smaller degree of scoliosis. Our research is expected to broaden the age-adaptation of classic spinal surgery in the field of pediatric spine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The research subjects are randomly assigned to the early surgery group (experimental group) or traditional surgery group (control group) at a ratio of 1:1
| Arm | Type | Receives |
|---|---|---|
| Early surgical group | Experimental | Procedure: posterior hemivertebra resectionThe subjects in this group received early surgical treatment, and they are arranged to be admitted to the hospital for surgical treatment after admission. The operation choice is posterior hemivertebrae resection + posterior pedicle screw placement + scoliosis correction. |
| Traditional surgical treatment | Active comparator | Procedure: conservative treatment+ delayed posterior hemivertebra resectionThis group of subjects received conservative treatment with custom-made braces to delay the progression of scoliosis. It is planned to use the classic posterior hemivertebrae resection + posterior pedicle screw placement + scoliosis correction to complete the correction around the age of 5. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Single-segment thoracic or lumbar hemivertebrae scoliosis diagnosed by X-ray and CT.
Key exclusion criteria (1 listed)
- Diagnosed with syndrome of scoliosis, osteochondrodysplasia, multi-segment hemivertebrae deformity, cervical hemivertebrae deformity
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 |
|---|---|---|
| posterior hemivertebra resectionThe subjects in early surgical group are arranged to be admitted to for surgical treatment very soon. The operation choice is posterior hemivertebrae resection + posterior pedicle screw placement + scoliosis correction. During operation pedicle screws are placed in the adjacent vertebrae of the head and tail of the Hemivertebra. Wedge resection of the hemivertebrae is performed afterward. Finally, two rods are placed between the pedicle screws. Intraoperative fluoroscopy confirms that the internal fixation position is good. | Procedure or surgery | Early surgical group |
| conservative treatment+ delayed posterior hemivertebra resectionIn traditional surgical group, subjects received conservative treatment firstly with custom-made braces to delay the progression of scoliosis. It is planned to use the classic posterior hemivertebrae resection + posterior pedicle screw placement + scoliosis correction to complete the correction around the age of 5. The operation choice is identical with early surgical group. During operation pedicle screws are placed in the adjacent vertebrae of the head and tail of the Hemivertebra. Wedge resection of the hemivertebrae is performed afterward. Finally, two rods are placed between the pedicle screws. Intraoperative fluoroscopy confirms that the internal fixation position is good. | Procedure or surgery | Traditional surgical treatment |
Primary outcome
Duration of surgery
Time frame: The operation time： from the beginning of the surgical skinning to the end of the surgical suture
The length of posterior hemivertebra resection operation time, acquired in the operation record from hospital
1 secondary outcome
change of scoliosis cobb angle
Time frame: intraoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 17513957Ginsburg G, Mulconrey DS, Browdy J. Transpedicular hemiepiphysiodesis and posterior instrumentation as a treatment for congenital scoliosis. J Pediatr Orthop. 2007 Jun;27(4):387-91. doi: 10.1097/01.bpb.0000271312.95621.b0.
- Individual participant dataSharing planned: No. depend on correspond
Related trials for Congenital Hemivertebra
RecruitingObservational study
Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children
Hemivertebra
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.
Dahui Wang, MD-PhD principal investigator
Children's hospital of fudan uviversity, shanghai, China
Questions about this trial
What is this clinical trial studying?
A study testing posterior hemivertebra resection and conservative treatment+ delayed posterior hemivertebra resection in people with Congenital Hemivertebra, run by Children's Hospital of Fudan University.
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: withdrawn, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Duration of surgery (time frame: The operation time： from the beginning of the surgical skinning to the end of the surgical suture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04527406, which also lists 1 linked publication.
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 27 Mar 2026.