Scoliosis; AdolescenceNCT03843216
End Growth Results for Conservative Treatment for Idiopahitc Scoliosis
An observational study of Scoliosis; Adolescence and Scoliosis Idiopathic, run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
Trial summary
This study evaluates in a prospectively collected multicenter cohort the existence, characteristics and determinants of EBPCA, the obtained results and their determinant, the rate of over- and under-treatment and their determinants. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis; Adolescence, Scoliosis Idiopathic
- What is being tested?
- observation, Physiotherapic scoliosis specific exercise and brace
- Type of treatment
- Medical device
- How many people
- 1,938 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Jul 2018
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Scoliotic patients that were referred to a tertiary clinic specialized on spine deformity.
Who may be able to join
- diagnosis of Adolescent Idiopathic Scoliosis (AIS),
- curves between 11 and 45° at start,
- Risser test between 0 and 2.
- Since our Institute receive many participants for a second opinion, we considered only participants in charge, defined as those who came at least three times to our facilities
Who cannot join
- previous bracing;
- absence of x-rays in the 3 months before/after the start and the end of treatment/observation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: End-growth Results of Tailored Treatment in 1938 Adolescents With High Risk Idiopathic Scoliosis: a Cohort Study From a Prospective Clinical Database
This study evaluates in a prospectively collected multicenter cohort the existence, characteristics and determinants of EBPCA, the obtained results and their determinant, the rate of over- and under-treatment and their determinants.
Read the detailed description
Since an evidence-based personalised conservative approach (EBPCA) to Adolescent Idiopathic Scoliosis has never been checked, the investigators studied a prospectively collected multicenter cohort with the aim to verify in the different clinical situations 1) the existence, characteristics and determinants of EBPCA; 2) the obtained results and their determinant; 3) the rate of over- and under-treatment and their determinants. These results are expected to check the actual evidence in everyday clinic, to provide a benchmark for future studies, and to inform guidelines producers and consequently health policy in high income countries, but also and particularly in low-middle income countries where surgery is difficult due to the high costs, and missing competences and structures.
- Conditions
- Scoliosis; Adolescence, Scoliosis Idiopathic
- Being tested
- observation, Physiotherapic scoliosis specific exercise, brace
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
patients not treated
Physiotherapic scoliosis specific exerciseOther
Specific exercise according to the SEAS (Scientific Exercises Approach to Scoliosis) protocol
braceDevice
different kind of braces being elastic, rigid or very rigid. All devices are custom made. The hours of application per day varied from 18 to 24h.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients achieving specific results
Outcomes were calculated as number of patients achieving specific results at the end of growth, including: 1) remaining below the significant prognostic thresholds of 30° and 50°; 2) improved or progressed beyond the measurement error of 5°; 3) achieving the treatment aims proposed by the current Guidelines : primary (optimal) and secondary (minimal); 4) receiving under- or over-treatment, that have been defined during study planning in relationship to the ideal final result.
Measured: End of growth as defined as radiological evidence of Risser 5 or Risser 4 and two years of no growth in height.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study startJan 2016
- Primary completionJan 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Scoliosis; AdolescenceStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,938 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Scientifico Italiano Colonna Vertebrale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Negrini, MD, Prof, Principal investigator, stefano.negrini@isico.it
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843216
- Sponsor's protocol ID
- EGR-ISICO
- Status last verified
- Feb 2019
- First submitted
- 25 Sep 2018
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.
PubMed 29435499Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19.
PubMed 24047455Di Felice F, Zaina F, Donzelli S, Negrini S. The Natural History of Idiopathic Scoliosis During Growth: A Meta-Analysis. Am J Phys Med Rehabil. 2018 May;97(5):346-356. doi: 10.1097/PHM.0000000000000861.
PubMed 29493563Negrini S, Hresko TM, O'Brien JP, Price N; SOSORT Boards; SRS Non-Operative Committee. Recommendations for research studies on treatment of idiopathic scoliosis: Consensus 2014 between SOSORT and SRS non-operative management committee. Scoliosis. 2015 Mar 7;10:8. doi: 10.1186/s13013-014-0025-4. eCollection 2015.
PubMed 25780381
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-growth Results of Tailored Treatment in 1938 Adolescents With High Risk Idiopathic Scoliosis: a Cohort Study From a Prospective Clinical Database
- ClinicalTrials.gov ID
- NCT03843216
- Acronym / sponsor ID
- EGR-ISICO
- Conditions
- Scoliosis; Adolescence, Scoliosis Idiopathic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,938 participants (actual)
- Lead sponsor
- Istituto Scientifico Italiano Colonna VertebraleUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 18 Feb 2019 (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.
This study evaluates in a prospectively collected multicenter cohort the existence, characteristics and determinants of EBPCA, the obtained results and their determinant, the rate of over- and under-treatment and their determinants.
Detailed description
Since an evidence-based personalised conservative approach (EBPCA) to Adolescent Idiopathic Scoliosis has never been checked, the investigators studied a prospectively collected multicenter cohort with the aim to verify in the different clinical situations 1) the existence, characteristics and determinants of EBPCA; 2) the obtained results and their determinant; 3) the rate of over- and under-treatment and their determinants. These results are expected to check the actual evidence in everyday clinic, to provide a benchmark for future studies, and to inform guidelines producers and consequently health policy in high income countries, but also and particularly in low-middle income countries where surgery is difficult due to the high costs, and missing competences and structures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Scoliotic patients that were referred to a tertiary clinic specialized on spine deformity.
Key inclusion criteria (4 listed)
- diagnosis of Adolescent Idiopathic Scoliosis (AIS),
- curves between 11 and 45° at start,
- Risser test between 0 and 2.
- Since our Institute receive many participants for a second opinion, we considered only participants in charge, defined as those who came at least three times to our facilities
Key exclusion criteria (2 listed)
- previous bracing;
- absence of x-rays in the 3 months before/after the start and the end of treatment/observation.
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 |
|---|---|---|
| observationpatients not treated | Other | – |
| Physiotherapic scoliosis specific exerciseSpecific exercise according to the SEAS (Scientific Exercises Approach to Scoliosis) protocol | Other | – |
| bracedifferent kind of braces being elastic, rigid or very rigid. All devices are custom made. The hours of application per day varied from 18 to 24h. | Device | – |
Primary outcome
Number of patients achieving specific results
Time frame: End of growth as defined as radiological evidence of Risser 5 or Risser 4 and two years of no growth in height.
Outcomes were calculated as number of patients achieving specific results at the end of growth, including: 1) remaining below the significant prognostic thresholds of 30° and 50°; 2) improved or progressed beyond the measurement error of 5°; 3) achieving the treatment aims proposed by the current Guidelines : primary (optimal) and secondary (minimal); 4) receiving under- or over-treatment, that have been defined during study planning in relationship to the ideal final result.
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 18 Feb 2019.
- Background: PubMed 29435499Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.
- Background: PubMed 24047455Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19.
- Background: PubMed 29493563Di Felice F, Zaina F, Donzelli S, Negrini S. The Natural History of Idiopathic Scoliosis During Growth: A Meta-Analysis. Am J Phys Med Rehabil. 2018 May;97(5):346-356. doi: 10.1097/PHM.0000000000000861.
- Background: PubMed 25780381Negrini S, Hresko TM, O'Brien JP, Price N; SOSORT Boards; SRS Non-Operative Committee. Recommendations for research studies on treatment of idiopathic scoliosis: Consensus 2014 between SOSORT and SRS non-operative management committee. Scoliosis. 2015 Mar 7;10:8. doi: 10.1186/s13013-014-0025-4. eCollection 2015.
- Individual participant dataSharing planned: Undecided
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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.
Stefano Negrini, MD, Prof principal investigator
stefano.negrini@isico.it
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis; Adolescence and Scoliosis Idiopathic, run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
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 4 inclusion and 2 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 18 Feb 2019. 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 Italy. 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?
Number of patients achieving specific results (time frame: End of growth as defined as radiological evidence of Risser 5 or Risser 4 and two years of no growth in height.). 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 NCT03843216, which also lists 4 linked publications.
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 18 Feb 2019.