NCT07559539

Brief Summary

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity, and a subset of patients undergo surgical correction during adolescence, most commonly posterior spinal fusion (PSF). Although surgical treatment improves deformity and quality of life in the short and mid-term, its long-term impact on functional status in adulthood remains insufficiently understood. This cross-sectional study aims to evaluate long-term outcomes in adults aged 25-40 years who underwent surgical treatment for AIS, compared with non-operated individuals with scoliosis and healthy controls. The study will assess limitations in daily functioning, musculoskeletal and respiratory function, pain, and compensatory mechanisms using standardized clinical measurements and questionnaires. The findings are expected to provide insight into long-term functional consequences of AIS and support the development of targeted physiotherapy and preventive strategies for adults treated for scoliosis during adolescence.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
27mo left

Started May 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

May 16, 2026

Expected
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2028

Last Updated

April 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.3 years

First QC Date

March 27, 2026

Last Update Submit

April 24, 2026

Conditions

Keywords

Adolescent Idiopathic Scoliosisadult scoliosisspinal fusionLong-Term Adverse Effects

Outcome Measures

Primary Outcomes (1)

  • ICF-Based Functional Limitations Questionnaire Total Score

    Author-developed questionnaire based on the International Classification of Functioning, Disability and Health (ICF), assessing body functions, activities, participation, and environmental factors. Higher total scores indicate greater disability.

    Baseline assessment, single study visit

Secondary Outcomes (7)

  • SRS-22 Total Score

    Baseline assessment, single study visit

  • Pain Intensity by Visual Analog Scale (VAS)

    Baseline assessment, single study visit

  • Forced Vital Capacity (FVC % Predicted)

    Baseline assessment, single study visit

  • Forced Expiratory Volume in 1 Second (FEV1 % Predicted)

    Baseline assessment, single study visit

  • Angle of Trunk Rotation

    Baseline assessment, single study visit

  • +2 more secondary outcomes

Other Outcomes (6)

  • Chest Expansion

    Baseline assessment, single study visit

  • Cervical Rotation Range of Motion

    Baseline assessment, single study visit

  • Peripheral Joint Range of Motion

    Baseline assessment, single study visit

  • +3 more other outcomes

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Polish patients

You may qualify if:

  • Female, age 25-40
  • AIS diagnosed before age 18 (Cobb angle \>35°)
  • Operated group: PSF, 10-25 years post-surgery
  • Informed consent

You may not qualify if:

  • Surgery other than PSF
  • Surgery performed in adulthood

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ScoliosisLong Term Adverse Effects

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 30, 2026

Study Start (Estimated)

May 16, 2026

Primary Completion (Estimated)

August 16, 2028

Study Completion (Estimated)

August 16, 2028

Last Updated

April 30, 2026

Record last verified: 2026-03