Spinal curvature
Conditions
Interventions
The spinal deformity of the patients will be surgically corrected using the
ApiFix system and sequential correction exercises.
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
12 Years to 17 Years
Inclusion 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness: 1. Correction of primary curve Cobb angle at 6 months follow-up (percentage and absolute degrees). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: 1. Curve progression above or below the implant over time at all follow-ups; 2. Vertebral rotation based on Bunnell Scoliometer; 3. Vertebral rotation based on AP X-ray using the Nash and Moe method [7], and; 4. (Serious) adverse event. Effectiveness: 1. Patient reported outcome (SRS-22); 2. Correction of primary curve Cobb angle to | — |
Countries
Netherlands
Outcome results
None listed