AISNCT06251505
Cervical Alignment Changes After Correction of Thoracic Adolescent Idiopathic Scoliosis With Thoracic Hypokyphosis
An observational study of AIS and Cervical Alignment, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The sagittal alignment of Adolescent Idiopathic Scoliosis (AIS) curves has attracted growing interest in recent years, to the extent that it has become a pivotal point in the Lenke classification, with the introduction of a sagittal modifier. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- AIS, Cervical Alignment, Thoracic Kyphosis
- How many people
- 57 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2023to 31 Dec 2024
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: AIS patients with a major thoracic curve (Lenke 1, 2 , 3 patterns), with associated severe thoracic hypokyphosis (TK < 10°; Lenke - modifier) who underwent surgical correction at the participating centers was performed.
Who may be able to join
- AIS patients with a major thoracic curve (Lenke 1, 2 , 3 patterns), with associated severe thoracic hypokyphosis (TK < 10°; Lenke - modifier) who underwent surgical correction at the participating centers was performed.
Who cannot join
- Non-idiopathic scoliosis, infantile, juvenile, or adult idiopathic scoliosis diagnosis were considered exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cervical Sagittal Alignment Changes After Correction of Thoracic Adolescent Idiopathic Scoliosis With Severe Thoracic Hypokyphosis: Which Factors Are Predictive? A Multicenter Retrospective Study
The sagittal alignment of Adolescent Idiopathic Scoliosis (AIS) curves has attracted growing interest in recent years, to the extent that it has become a pivotal point in the Lenke classification, with the introduction of a sagittal modifier. In particular, thoracic curves, partly due to the theory of anterior overgrowth, are almost invariably characterized by thoracic hypokyphosis, which can be severe (T5-T12 thoracic kyphosis < 10°, that corresponds to a Lenke - sagittal modifier). However, the development of such a severely abnormal sagittal alignment has consequences that are not limited only to the thoracic region, but it rather results in a disruption of the entire sagittal spinal alignment. In fact, thoracic hypokyphosis tends to shift the C7SVA backward and to decrease the T1 slope. As a compensation, this ultimately leads to the development of a cervical kyphosis in order to translate the head forward and maintain global sagittal balance. While the interplay relationship between thoracic hypokyphosis and the development of cervical kyphosis has been well established in modern literature, the results regarding the amount of spontaneous correction of cervical kyphosis achieved after hypokyphotic AIS correction are conflicting. There are several papers in literature that study the complex relationship between AIS and cervical kyphosis, and they did not report any improvement in cervical lordosis after AIS correction, even when successful restoration of thoracic kyphosis (TK) was achieved. Conversely, other authors did report an improvement in cervical sagittal alignment after AIS correction. The aim of the present paper is firstly to assess the amount of spontaneous change in cervical sagittal alignment after correction of AIS with associated severe thoracic hypokyphosis (<10°). Secondly, the aim of the study is to seek for any radiographical parameter able to predict the postoperative cervical sagittal alignment in these patients, via a multivariate regression analysis.
- Conditions
- AIS, Cervical Alignment, Thoracic Kyphosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical alignment
to assess the amount of spontaneous change in cervical sagittal alignment after correction of AIS with associated severe thoracic hypokyphosis (<10°)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start30 Apr 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AISStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251505
- Sponsor's protocol ID
- Bol-Ter AIS
- Status last verified
- Mar 2025
- First submitted
- 15 Jan 2024
- Last updated
- 19 Mar 2025
- Results posted
- 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Sagittal Alignment Changes After Correction of Thoracic Adolescent Idiopathic Scoliosis With Severe Thoracic Hypokyphosis: Which Factors Are Predictive? A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT06251505
- Acronym / sponsor ID
- Bol-Ter AIS
- Conditions
- AIS, Cervical Alignment, Thoracic Kyphosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Feb 2024 (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 sagittal alignment of Adolescent Idiopathic Scoliosis (AIS) curves has attracted growing interest in recent years, to the extent that it has become a pivotal point in the Lenke classification, with the introduction of a sagittal modifier. In particular, thoracic curves, partly due to the theory of anterior overgrowth, are almost invariably characterized by thoracic hypokyphosis, which can be severe (T5-T12 thoracic kyphosis < 10°, that corresponds to a Lenke - sagittal modifier). However, the development of such a severely abnormal sagittal alignment has consequences that are not limited only to the thoracic region, but it rather results in a disruption of the entire sagittal spinal alignment. In fact, thoracic hypokyphosis tends to shift the C7SVA backward and to decrease the T1 slope. As a compensation, this ultimately leads to the development of a cervical kyphosis in order to translate the head forward and maintain global sagittal balance. While the interplay relationship between thoracic hypokyphosis and the development of cervical kyphosis has been well established in modern literature, the results regarding the amount of spontaneous correction of cervical kyphosis achieved after hypokyphotic AIS correction are conflicting. There are several papers in literature that study the complex relationship between AIS and cervical kyphosis, and they did not report any improvement in cervical lordosis after AIS correction, even when successful restoration of thoracic kyphosis (TK) was achieved. Conversely, other authors did report an improvement in cervical sagittal alignment after AIS correction. The aim of the present paper is firstly to assess the amount of spontaneous change in cervical sagittal alignment after correction of AIS with associated severe thoracic hypokyphosis (<10°). Secondly, the aim of the study is to seek for any radiographical parameter able to predict the postoperative cervical sagittal alignment in these patients, via a multivariate regression analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- AIS patients with a major thoracic curve (Lenke 1, 2 , 3 patterns), with associated severe thoracic hypokyphosis (TK < 10°; Lenke - modifier) who underwent surgical correction at the participating centers was performed.
Key inclusion criteria (1 listed)
- AIS patients with a major thoracic curve (Lenke 1, 2 , 3 patterns), with associated severe thoracic hypokyphosis (TK < 10°; Lenke - modifier) who underwent surgical correction at the participating centers was performed.
Key exclusion criteria (1 listed)
- Non-idiopathic scoliosis, infantile, juvenile, or adult idiopathic scoliosis diagnosis were considered exclusion criteria
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
Cervical alignment
Time frame: 4 years
to assess the amount of spontaneous change in cervical sagittal alignment after correction of AIS with associated severe thoracic hypokyphosis (<10°)
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 19 Mar 2025.
- 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?
An observational study of AIS and Cervical Alignment, run by Istituto Ortopedico Rizzoli 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 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 19 Mar 2025. 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?
Cervical alignment (time frame: 4 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 19 Mar 2025.