NL-OMON49966
Recruiting
Not Applicable
on fusion surgery in adolescent idiopathic scoliosis patients using the Nemost system - Non fusion surgery in AIS patients / NEMOST-AIS study
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 18
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 2 to 17 (—)
Inclusion Criteria
- •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
- •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.
Investigators
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