Evaluation of the safety and effectiveness of the MID-C/ApiFix system in adolescent idiopathic scoliosis.

Completed

Conditions: 10028377
10005944
Spinal curvature

Registration Number: NL-OMON43676

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 33

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Effectiveness:<br /><br>1. Correction of primary curve Cobb angle at 6 months follow-up (percentage and<br /><br>absolute degrees).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety:<br /><br>1. Curve progression above or below the implant over time at all follow-ups;<br /><br>2. Vertebral rotation based on Bunnell Scoliometer;<br /><br>3. Vertebral rotation based on AP X-ray using the Nash and Moe method [7], and;<br /><br>4. (Serious) adverse event.<br /><br><br /><br>Effectiveness:<br /><br>1. Patient reported outcome (SRS-22);<br /><br>2. Correction of primary curve Cobb angle to <35 degrees Cobb angle at 6 months<br /><br>follow-up;<br /><br>3. Correction of primary curve Cobb angle over time at all follow-ups, and;<br /><br>4. Correction of secondary curve Cobb angle over time at all follow-ups.</p><br>