ScoliosisNCT02819245
Impact of Age on Surgical Outcome of Adolescent Idiopathic Scoliosis
A study testing posterior correction and fusion in people with Scoliosis, run by Nanjing University School of Medicine at 1 site in China.
Trial summary
This is a study prospectively enrolling adolescent idiopathic scoliosis (AIS) patients and try to find how the age will impact the surgical outcome of AIS. Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- posterior correction and fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jan 2003to Dec 2018
- 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 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent idiopathic scoliosis patients; undergoing posterior correction surgery; with minimum 5 years follow-up; with full-spine radiography.
Who cannot join
- with spinal tumor; with hip disease; without quality of life measurements.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Hongda Bao, 6463872363, baohongda123@gmail.com
About this study
This is a study prospectively enrolling adolescent idiopathic scoliosis (AIS) patients and try to find how the age will impact the surgical outcome of AIS.
- Conditions
- Scoliosis
- Being tested
- posterior correction and fusion
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior correction and fusionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Age before and after 18 years old | Other | Surgical treatment before and after skeletal maturity Receives: Procedure: posterior correction and fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of coronal Cobb angle
Cobb angles, including thoracic and lumbar Cobb angle, are measured from coronal radiographs with validated software (Surgimap).
Measured: From immediate post-operative until at least 10 years follow-up
Secondary outcomes (2)
Improvement of sagittal profile
Sagittal profile, described sagittal radiographic parameters such as thoracic kyphosis and lumbar lordosis, is measured with validated software (Surgimap).
Measured: From immediate post-operative until at least 10 years follow-up
Health-related quality of life (HRQOL)
HRQOL measurements include Short Form 36 (SF-36), Scoliosis Research Society (SRS) 22 questionnaire and Visual Analogue Scale (VAS).
Measured: From immediate post-operative until at least 10 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startJan 2003
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongda Bao, Nanjing University School of Medicine
- Investigators
- Yong Qiu, Study chair, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819245
- Sponsor's protocol ID
- 2003-01-15-scoliosis
- Status last verified
- Jun 2016
- First submitted
- 24 Jun 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Age on Surgical Outcome of Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT02819245
- Acronym / sponsor ID
- 2003-01-15-scoliosis
- Conditions
- Scoliosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2018 (estimated)
- First posted
- 30 Jun 2016 (estimated)
- 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.
This is a study prospectively enrolling adolescent idiopathic scoliosis (AIS) patients and try to find how the age will impact the surgical outcome of AIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Age before and after 18 years old | Other | Procedure: posterior correction and fusionSurgical treatment before and after skeletal maturity |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescent idiopathic scoliosis patients; undergoing posterior correction surgery; with minimum 5 years follow-up; with full-spine radiography.
Key exclusion criteria (1 listed)
- with spinal tumor; with hip disease; without quality of life measurements.
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 correction and fusion | Procedure or surgery | Age before and after 18 years old |
Primary outcome
Improvement of coronal Cobb angle
Time frame: From immediate post-operative until at least 10 years follow-up
Cobb angles, including thoracic and lumbar Cobb angle, are measured from coronal radiographs with validated software (Surgimap).
2 secondary outcomes
Improvement of sagittal profile
Time frame: From immediate post-operative until at least 10 years follow-up
Health-related quality of life (HRQOL)
Time frame: From immediate post-operative until at least 10 years follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
- 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.
Yong Qiu study chair
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing posterior correction and fusion in people with Scoliosis, run by Nanjing University School of Medicine 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: status not confirmed, as of the sponsor's last update on 30 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongda Bao (6463872363, baohongda123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of coronal Cobb angle (time frame: From immediate post-operative until at least 10 years follow-up). 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 30 Jun 2016.