Adolescent Idiopathic ScoliosisAISNCT01661959
Adolescent Idiopathic Scoliosis Outcomes Database Registry
An observational study of Adolescent Idiopathic Scoliosis, run by Setting Scoliosis Straight Foundation at 14 sites in 2 countries.
Trial summary
The purpose of this study is to analyze the long-term outcomes of surgical treatment of idiopathic scoliosis of all curve patterns treated by either anterior or posterior procedures. In addition, to analyze the long-term outcomes of non-operative idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- How many people
- 10,000 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Jan 2005to Dec 2025
- Phase
- Observational
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study.
Who may be able to join
- Patients aged ≥ 10 and ≤ 21 years at time of enrollment,
- male or female,
- diagnosis of idiopathic scoliosis for which surgery is recommended to prevent progression of the curvature or to correct trunk disfigurement.
- Curve cobb of any magnitude - operative range
- Spina bifida Oculta is permitted
- Spondylolisthesis and Spondylolysis are permitted, as long as non-operative
Show all 10Show fewer
- Non-operative idiopathic scoliosis patients:
- aged ≥ 10 and ≤ 21 years, male or female, curve cobb of ≥ 40º, for whom surgery has been offered and the patient has elected not to proceed with surgery.
- OR
- OPTIONAL BY SITE: aged ≥ 10 and ≤ 21 years, male or female, Curve cobb ≥ 30º and skeletally mature (with maturity defined as Age: girls > 14 yrs; Boys > 16 yrs and Risser of ≥ 4 Plus one of the following: Girls 2+ yrs post menarchal, boys shaving regularly, no height change in at least 6 months.
Who cannot join
- Prior spinal surgery
- MRI abnormalities (including > 4mm of Syrinx and/or Chiari malformation)
- Neuromuscular or other serious co-morbidities
- Thoracogenic or cardiogenic scoliosis
- Associated syndrome or developmental delay
- Unable or unwilling to firmly commit to returning for required follow-up visits
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States12 sites
John's Hopkins Medical Institute
Baltimore, Maryland, 21287
Boston Children's Hospital
Boston, Massachusetts, 02115
University Physicians
Camden, New Jersey, 08103
Cincinnati Children's Hospital, Cincinnati, OH
Cincinnati, Ohio, 45229
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Miami Children's Hospital
Miami, Florida, 33155
Scoliosis Associates
New York, New York, 10017
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Shriners Hospital for Children
Philadelphia, Pennsylvania, 19140
Rady Children's Hospital
San Diego, California, 92123
Washington Univ., St. Louis
St Louis, Missouri, 63110
Nemours Children's Clinic
Wilmington, Delaware, 19803
Canada2 sites
CHU Saint-Justine Hospital
Montreal
British Columbia Children's Hospital
Vancouver
About this study
Official title: Scoliosis Outcomes Database Registry
The purpose of this study is to analyze the long-term outcomes of surgical treatment of idiopathic scoliosis of all curve patterns treated by either anterior or posterior procedures. In addition, to analyze the long-term outcomes of non-operative idiopathic scoliosis.
Read the detailed description
- The first aim of this Database Registry is to maintain a prospective multicenter series of patients treated surgically for adolescent idiopathic scoliosis. Patients from multiple scoliosis centers around the U.S., as well as a center in Germany, will be enrolled with comprehensive analysis of the curve pattern being treated, as well as the type of surgery performed. The outcome of each surgical treatment will be analyzed. This will allow the frequency of various curve types to be determined, as well as the frequency of various surgical approaches utilized for each curve pattern.
- The second aim is to determine if operative outcomes vary based on the surgical approach utilized in scoliosis correction. In this analysis, it is anticipated that specific approaches can be identified to be most appropriate for given scoliotic curve patterns. In addition, the variations within individual curve patterns will be analyzed, as will specific variations in the surgical approach (e.g., distal level of instrumentation, hooks versus screws, hook patterns, etc).
- The third aim is to develop an algorithm to guide surgical decision making based on a scoliosis curve classification scheme that will allow the surgeon to provide the best overall outcome (radiographic, functional, cosmetic) for a given patient with idiopathic scoliosis.
- The fourth aim is to evaluate the long-term outcomes of surgical intervention in this patient population.
- The fifth aim is to maintain a prospective multi-center series of patients with idiopathic scoliosis who have not undergone surgical correction of their deformity. The long-term outcome of this patient population will be compared with the surgical patient population.
- The sixth aim is to develop a guide to help clinicians make a decision for optimal surgical treatment of AIS curves based on patient-specific 3D information.
- Factors that may influence intra and post-operative course will also be evaluated. Of particular interest are patient specific factors (curve size, pre op characteristics such as blood work and PFT testing) and their influence on intra-operative blood loss.
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Scoliosis, Multi-center Database Registry, Spinal Deformity, Adolescent Idiopathic Scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-Operative | Not described | |
| Operative | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in radiographic outcome for surgical treatment of idiopathic scoliosis.
Patients are followed up to 25 years post-op.
Measured: 25 years
Secondary outcomes (1)
Change in clinical outcomes for surgical treatment of idiopathic scoliosis.
Patients are followed up to 25 years post-op
Measured: 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startJan 2005
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Setting Scoliosis Straight Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Spine, NuVasive
- Responsible party
- Sponsor
- Investigators
- Peter O Newton, MD, Principal investigator, Rady Children's Hospital San Deigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661959
- Sponsor's protocol ID
- 2007HSGAIS
- Acronym
- AIS
- Status last verified
- Nov 2023
- First submitted
- 10 Jul 2012
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scoliosis Outcomes Database Registry
- ClinicalTrials.gov ID
- NCT01661959
- Acronym / sponsor ID
- AIS / 2007HSGAIS
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Scoliosis, Multi-center Database Registry, Spinal Deformity, Adolescent Idiopathic Scoliosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Setting Scoliosis Straight FoundationUniversity, hospital or other
- Collaborators
- DePuy Spine, NuVasive
- Study start
- Jan 2005
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Aug 2012 (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.
The purpose of this study is to analyze the long-term outcomes of surgical treatment of idiopathic scoliosis of all curve patterns treated by either anterior or posterior procedures. In addition, to analyze the long-term outcomes of non-operative idiopathic scoliosis.
Detailed description
- The first aim of this Database Registry is to maintain a prospective multicenter series of patients treated surgically for adolescent idiopathic scoliosis. Patients from multiple scoliosis centers around the U.S., as well as a center in Germany, will be enrolled with comprehensive analysis of the curve pattern being treated, as well as the type of surgery performed. The outcome of each surgical treatment will be analyzed. This will allow the frequency of various curve types to be determined, as well as the frequency of various surgical approaches utilized for each curve pattern.
- The second aim is to determine if operative outcomes vary based on the surgical approach utilized in scoliosis correction. In this analysis, it is anticipated that specific approaches can be identified to be most appropriate for given scoliotic curve patterns. In addition, the variations within individual curve patterns will be analyzed, as will specific variations in the surgical approach (e.g., distal level of instrumentation, hooks versus screws, hook patterns, etc).
- The third aim is to develop an algorithm to guide surgical decision making based on a scoliosis curve classification scheme that will allow the surgeon to provide the best overall outcome (radiographic, functional, cosmetic) for a given patient with idiopathic scoliosis.
- The fourth aim is to evaluate the long-term outcomes of surgical intervention in this patient population.
- The fifth aim is to maintain a prospective multi-center series of patients with idiopathic scoliosis who have not undergone surgical correction of their deformity. The long-term outcome of this patient population will be compared with the surgical patient population.
- The sixth aim is to develop a guide to help clinicians make a decision for optimal surgical treatment of AIS curves based on patient-specific 3D information.
- Factors that may influence intra and post-operative course will also be evaluated. Of particular interest are patient specific factors (curve size, pre op characteristics such as blood work and PFT testing) and their influence on intra-operative blood loss.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Operative | – | – |
| Operative | – | – |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study.
Key inclusion criteria (10 listed)
- Patients aged ≥ 10 and ≤ 21 years at time of enrollment,
- male or female,
- diagnosis of idiopathic scoliosis for which surgery is recommended to prevent progression of the curvature or to correct trunk disfigurement.
- Curve cobb of any magnitude - operative range
- Spina bifida Oculta is permitted
Key exclusion criteria (6 listed)
- Prior spinal surgery
- MRI abnormalities (including > 4mm of Syrinx and/or Chiari malformation)
- Neuromuscular or other serious co-morbidities
- Thoracogenic or cardiogenic scoliosis
- Associated syndrome or developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in radiographic outcome for surgical treatment of idiopathic scoliosis.
Time frame: 25 years
Patients are followed up to 25 years post-op.
1 secondary outcome
Change in clinical outcomes for surgical treatment of idiopathic scoliosis.
Time frame: 25 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Harms Study GroupLink provided by the sponsor.
Related trials for Adolescent Idiopathic Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
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.
Peter O Newton, MD principal investigator
Rady Children's Hospital San Deigo
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis, run by Setting Scoliosis Straight Foundation at 14 sites in 2 countries.
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 10 inclusion and 6 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 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. 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?
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?
Change in radiographic outcome for surgical treatment of idiopathic scoliosis. (time frame: 25 years). 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 21 Nov 2023.