Evaluation of the safety and effectiveness of the MID- C system in adolescent idiopathic scoliosis.
Recruiting
- Conditions
- Surgical treatment of adolescent idiopathic scoliosis (AIS).
- Registration Number
- NL-OMON21786
- Lead Sponsor
- VU University Medical Center, Amsterdam, The Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 33
Inclusion Criteria
1. Adolescent AIS patients (12 years - 17 years old);
2. Standing X-ray: 40 to 55 degrees Cobb angle, Lenke type 1 or 5, Risser stage 1-4;
Exclusion Criteria
1.Other non-idiopathic form of scoliosis;
2.Primary curve Cobb angle >55 degrees;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Correction of primary curve Cobb angle at 6 months follow-up (percentage and absolute degrees).
- Secondary Outcome Measures
Name Time Method 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 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.<br>