AI-Powered Research

1. Adoleschent idiopathic scoliosis patients (7-16 years);
2. Pre menarch, or up to 6 months post menarch;
3. Standing x-ray: 25 to 55 degrees Cobb angle, Lenke 1 to 6, Risser stage 0 or
1;
4. Subject has good general health;
5. Subject and both subject's guardians/ legal representatives are willing to
sign a written informed consent form;
6. Brace failure, no brace compliance or no brace treatment.

Exclusion Criteria

1. Previous spine surgery;
2. Other non-idiopathic forms of scoliosis;
3. Primary curve with a Cobb > 55 degrees;
4. Known allergy to titanium;
5. Active systemic disease, such as AIDS, HIV, or active infection
6. Systemic disease that would affect the subject's wellfare or overall outcome
of the study, or;
7. Mentally compromised.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Efficacy: Primary endpoint: Correction of primary curve Cobb angle at 2 years<br /><br>after skeletal maturity.<br /><br>Subgoals<br /><br>1. Correction of curvature directly after implantation of Nemost-AIS (Cobb<br /><br>angle preoperative vs Cobb angle directly postoperative<br /><br>2. Enabled growth (T1-S1 length, lengthening of Nemost-AIS)<br /><br>3. Correction of curvature at maturity (Cobb angle preoperative vs Cobb angle<br /><br>at maturity)<br /><br><br /><br>- Safety: Treatment related complications as (Serious) Adverse Event rate,<br /><br>reoperation rate, spine arthrodesis. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Effectiveness<br /><br>Radiological assessments:<br /><br>* Coronal balance (pimary and secondary curve Cobb angle) ;<br /><br>* Sagittal balance (thoracic kyphosis, lumbar lordosis, proximal and distal<br /><br>junctional angle);<br /><br>* Pelvic parameters (pelvic obliquity, sacral slope, pelvic incidence, pelvic<br /><br>tilt)<br /><br>* Vertebral rotation based on PA X-Ray<br /><br>Clinical assessments:<br /><br>* Patient appearance: shoulder imbalance, pelvic imbalance, gibbosity,<br /><br>vertebral rotation (based on scoliometer assesment)<br /><br>* Patient Reported Outcome (PRO) - SRS-22 (The Scoliosis Research Society*s-22<br /><br>questionnaire measures multiple domains as pain, self-image, function, and<br /><br>satisfaction with management).</p><br>