Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-24 @ 2:03 PM
NCT ID:
NCT01465295
Eligibility Criteria:
Inclusion Criteria:
\- Patients must meet all the criteria to be enrolled in this study:
* Trial subject population will involve patients who are skeletally immature, who have a diagnosis of idiopathic scoliosis with a single main thoracic curve Cobb angle 25° to 40° and Lenke Type 1A or 1B.
1. Chronologic age:
* Males ≥ 10 years
* Females ≥ 10 years
2. Females pre-menarchal at screening examination
3. Bone age as confirmed by radiographs of left hand and wrist according to the "Atlas Matching" method of Greulich and Pyle:
* Females: ≥ 8 years and 10 months not to exceed 13 years
* Males: ≥ 10 years not to exceed 15 years
4. Skeletal immaturity (Risser grade 0 and the triradiate cartilage is open) as determined by standing, upright PA radiograph. If radiographic Risser grade results are indeterminate, the bone age from the Atlas Matching will prevail.
5. Main thoracic Cobb angle of 25° to 40° as determined from standing, upright PA radiographs where the end vertebra are between or including T3 and L1 without wearing a brace
6. Clinical diagnosis of idiopathic scoliosis with a single main thoracic curve as determined with measurement on standing posterior- anterior PA radiographs.
* Defined as a single thoracic curve where either: central sacral vertical line (CSVL) passes between the pedicles of the apical lumbar vertebra; or the CSVL touches the lumbar apical body(ies) (Lenke Type 1A or 1B, respectively)
7. Achievable anatomical fit as determined by calibrated standing PA film:
* Disc height not exceeding 10 mm at each spinal level to be instrumented relative to location of the probable implant and
* Minimum central vertebral height that will accept the selected HemiBridge™ Clip size at all levels planned for implants
8. BMI \< 30
9. Physical and mental ability to undergo surgery with single lung ventilation
10. Written informed assent from the patient
11. Written informed consent from parent and/or legal guardian and authorization to use protected health information (by Sponsor, third party core lab and/or clinical evaluation committee)
Exclusion Criteria:
* Patients who meet any of the exclusion criteria will not be enrolled.
1. Non-idiopathic scoliosis
2. Males and females chronological age \< 10 years
3. Triradiate cartilage is closed as determined on the standing PA radiograph at baseline screening
4. Any curve type that does not meet definition of Lenke 1A or 1B
5. Any main thoracic deformity that measures \< 25° or \> 40° Cobb angle
6. Any main thoracic deformity that includes vertebral levels including and cranial to T2
7. Any main thoracic deformity that includes vertebral levels including and caudal to L2
8. Prior thoracotomy, thoracostomy or any spine surgery
9. T3-T12 kyphosis \> 40° (T4 or T5-T12 if visualization impaired at T3)
10. Known history or existing malignancy, or any systemic or local infection
11. Spinal cord abnormalities that require treatment
12. Presence of neurological deficit (motor grades 0-4, sensory grades 0-1, reflexes grade 0 or 5 or asymmetry of deep tendon reflexes \> 2 from right to left)
13. Insulin-dependent diabetes
14. Severe asthma
15. Reduced pulmonary function, defined as \< 60% of predicted value (Forced expiratory volume in one second \[FEV1\] divided by forced vital capacity \[FVC\]) or Subject has moderately severe or worse ventilatory limitation defined as \< 60% of predicted value of the forced vital capacity \[FVC\] for age, race, sex and height (with height determined by arm span in patients with scoliosis and reference equations derived from the data of Wang et al 199329.)
16. Cardiopulmonary or other systemic disease
17. Bleeding disorder(s)
18. Ataxia
19. Documented HIV or hepatitis infection
20. Family history of neurofibromatosis or Marfan's syndrome
21. Medical contraindication to anesthesia
22. Suspected or known allergy to titanium
23. Not available for interval visits and long term follow-up exams
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT01465295
Study Brief:
Protocol Section:
NCT01465295