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

March 18, 2025 updated by: Istituto Ortopedico Rizzoli

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

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.

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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°)
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bol-Ter AIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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