scoliosis
Conditions
Interventions
Surgical posterior instrumentation and fusion, in accordance with the standard.
There will be randomized between proximal fixation of the instrumentation with
a hook claw construct or with a pedicle
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: As according to Bridwell: - adolescent idiopathic scoliosis - coronal Cobb angle of >50° - coronal Cobb angle of >40° in the skeletally immature patient - progressive scoliosis despite bracing (at least 5 degrees annually) - age at surgery between 8 and 20 years - Lenke curve type 1-6 - informed consent
Exclusion criteria
Exclusion criteria: - neuromuscular scoliosis - congenital scoliosis - planned for posterior fusion in combination with anterior release, i.e. severe hyperkyphosis - prior spinal surgery - intraspinal pathology - not able to speak or read Dutch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in coronal Cobb angles after two year of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Is there a difference in • coronal Cobb angle correction direct postoperatively; • correction loss during (at least) two years of follow-up; • vertebral rotation correction; • complication and/or revision rate; • effects on pulmonary function; • postoperative lung volume; • cosmetic outcomes; • subjective questionnaire results (including patient*s satisfaction); between proximal pedicle screw fixation and proximal hook claw fixation? - Is there a correlation between the extent of scoliosis correction and the degree of patient satisfaction? - How is the accuracy of thoracic pedicle screw placement? | — |
Countries
Netherlands
Outcome results
None listed