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CompletedNCT06251505Updated Mar 19, 2025

Cervical Alignment Changes After Correction of Thoracic Adolescent Idiopathic Scoliosis With Thoracic Hypokyphosis

An observational study in AIS, Cervical Alignment and Thoracic Kyphosis, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 11 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by Istituto Ortopedico Rizzoli · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
57
Ages
11 Years to 18 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • AIS
  • Cervical Alignment
  • Thoracic Kyphosis

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03

In context

Scoliosis

594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.

This study's enrollment of 57 is below the median of 89 across 233 observational studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Non-idiopathic scoliosis, infantile, juvenile, or adult idiopathic scoliosis diagnosis were considered exclusion criteria
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
57 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Cervical alignment

    to assess the amount of spontaneous change in cervical sagittal alignment after correction of AIS with associated severe thoracic hypokyphosis (\<10°)

    Time frame: 4 years

07

Study locations

1 site
  • Istituto Ortopedico Rizzoli
    Bologna, 40136, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06251505
Lead sponsor
Istituto Ortopedico Rizzoli
Responsible party
Sponsor
First posted
Feb 9, 2024
Start date
Apr 30, 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2024
Last update
Mar 19, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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