NCT06396286

Brief Summary

Idiopathic scoliosis of developmental age (AIS) is the most vertebral deformity in the adolescent population, with a prevalence of 1-3%. The treatment of AIS depends on the morphology and extent of the curve and the growth potential residual, can range from simple clinical-radiological monitoring, to the use of braces to, in the most severe cases, correction surgical correction. The indication for surgical correction of AIS depends on the location, extent and flexibility of the scoliotic curve and not least on the patient's age or, better, the skeletal age. The primary goal of surgery is to correcting the deformity by preventing its progression, preserving as many motion segments as possible; secondarily, the surgery aims to restore the coronal and sagittal balance of the spine.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Progress86%
Jun 2024Sep 2026

First Submitted

Initial submission to the registry

April 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

June 12, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

1.3 years

First QC Date

April 29, 2024

Last Update Submit

December 23, 2025

Conditions

ScoliosisSpine DeformityAdolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (6)

  • Spine Correction

    The correction of the curvature of the back will be evaluated via x-ray

    at baseline

  • Spine Correction

    The correction of the curvature of the back will be evaluated via x-ray

    at 12 months

  • Quality of Life 1

    The "Scoliosis Research Society 22" is a multidimensional questionnaire covering the four non-management domains of pain, function, self-image, and mental health (5 items per domain), along with 2 items to assess the patient's satisfaction with management of their deformity

    at baseline

  • Quality of Life 1

    The "Scoliosis Research Society 22" is a multidimensional questionnaire covering the four non-management domains of pain, function, self-image, and mental health (5 items per domain), along with 2 items to assess the patient's satisfaction with management of their deformity

    at 12 months

  • Quality of Life 2

    The Oswestry Disability Index (ODI) a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from back pain.

    at baseline

  • Quality of Life 2

    The Oswestry Disability Index (ODI) a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from back pain.

    at 12 months

Study Arms (1)

experimental

EXPERIMENTAL

severe adolescent idiopathic scoliosis Lenke 1

Procedure: single rod

Interventions

single rodPROCEDURE

surgical correction of severe adolescent idiopathic scoliosis with screws and a single rod.

experimental

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of AIS;
  • Male and female sex;
  • Age between 12 and 21;
  • Thoracic scoliotic curve, type I according to Lenke's classification;
  • Preoperative radiographic range of the main scoliotic curve between 40° and 70° Cobb;
  • Reducibility of the curve on bending radiographs by 30%;
  • Signature of the informed consent of patients/parents to actively participate in the study and clinical follow-up.

You may not qualify if:

  • Scoliosis with an etiology different from AIS;
  • pre-operative COBB \> 70°;
  • Patients already treated surgically for scoliosis;
  • Location of the scoliotic curve: Lenke 2-6;
  • Patients who do not fall within the parameters described;
  • Patients unable to express consent or carry out follow-ups;
  • Language barrier;
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (2)

  • Lenke LG. Lenke classification system of adolescent idiopathic scoliosis: treatment recommendations. Instr Course Lect. 2005;54:537-42.

    PMID: 15948478RESULT

  • Renshaw TS. The role of Harrington instrumentation and posterior spine fusion in the management of adolescent idiopathic scoliosis. Orthop Clin North Am. 1988 Apr;19(2):257-67.

    PMID: 3282199RESULT

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 2, 2024

Study Start

June 12, 2024

Primary Completion

September 29, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations

IT(1)