NL-OMON43676
Completed
N/A
Evaluation of the safety and effectiveness of the MID-C/ApiFix system in adolescent idiopathic scoliosis. - The ApiFix system for the treatment of adolescent idiopathic scoliosis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Spinal curvature
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 33
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adolescent idiopathic scoliosis patients (10 years \- 17 years old);
- •2\. Standing X\-ray: 40 to 55 degrees Cobb angle, Lenke type 1 or 5, Risser stage 1\-4;
- •3\. Lateral bending X\-ray: primary curve should be reduced to \<35 degrees Cobb angle after lateral bending;
- •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\. Vertebral rotation \<15 degrees (based on Bunnell Scoliometer), and;
- •7\. Compliance for exercise therapy (based on verbal confirmation of patient)
Exclusion Criteria
- •1\. Other non\-idiopathic form of scoliosis;
- •2\. Primary curve Cobb angle \>50 degrees;
- •3\. Adolescent idiopathic scoliosis which is not defined as Lenke type 1 or 5;
- •4\. Previous spine surgery;
- •5\. Known allergy to titanium;
- •6\. Active systemic disease, such as AIDS, HIV, or active infection;
- •7\. Systemic disease that would affect the subject\*s welfare or overall outcome of the study, or;
- •8\. Mentally compromised.
Outcomes
Primary Outcomes
Not specified
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