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van CCT (UK)

van CCT (UK)

Adolescent idiopathic scoliosis: fixation of the back by screw or hook fixation?

- candidate number23638
- NTR NumberNTR5674
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jan-2016
- Secondary IDsNL36436.078.11 
- Public TitleAdolescent idiopathic scoliosis: fixation of the back by screw or hook fixation?
- Scientific TitleDorsal spondylodesis in adolescent idiopathic scoliosis: proximal fixation with screws versus claw construct
- hypothesisProximal fixation of the spondylodesis with a pedicle screw construct gives better coronal Cobb angle correction with less loss of correction compared to a hook claw construct.
- Healt Condition(s) or Problem(s) studiedAdolescent idiopathic scoliosis, Spondylodesis
- Inclusion criteria- 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
- structural thoracic curves (Lenke curve type 1-4)
- informed consent
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2016
- planned closingdate1-jan-2021
- Target number of participants60
- InterventionsSurgical posterior instrumentation and fusion, in accordance with the standard. There will be a randomization between proximal fixation of the instrumentation with a hook claw construct or with a pedicle screw construct. Both surgical treatments are valid options in the standard care of patients with adolescent idiopathic scoliosis.
- Primary outcomeThe primary study parameter is difference in coronal Cobb angles after two years of follow-up.
- Secondary outcome- vertebral rotation angles
- number of complications and/or revisions
- pulmonary function measures
- vital capacity (VC)
- absolute and percent predictive forced vital capacity (FVC)
- absolute and percent predictive forced expiratory volume in 1 second
- FEV-1/VC ratio
- lung volume
- preoperative and postoperative clinical photographs
- questionnaire results (SRS-30, CHQ-CF87, CHQ-PF50)
- CT evaluation of accuracy of pedicle screw placement within the pedicle
- serum measurements of cobalt and chromium at seven certain moments
- Timepointspre-operatively, perioperatively, and postoperatively at 6 weeks, 3 months, 6 months, 1 year and 2 years.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Erasmus Medical Center, Department of Orthopaedics
- Funding
(Source(s) of Monetary or Material Support)
Zimmer Biomed
- Publications
- Brief summarySurgical treatment of progressive or severe adolescent idiopathic scoliosis (AIS) often consists of posterior spinal fusion. There is still no consensus on the preferred instrumentation technique. Recently, the concept of using all pedicle screw instrumentation has been popularized. Thoracic pedicle screws are generally believed to give a better correction of coronal Cobb angle and vertebral rotation, and to have a higher pull-out strength. However, these studies have poor to fair methodological quality, and at least the clinical relevance of these findings is not clear. In our hospital we haven been using a proximal hook claw construct for years with good results. We hypothesize that proximal fixation of the spondylodesis with a pedicle screw construct gives better coronal Cobb angle correction with less loss of correction compared to a hook claw construct.
Besides, most spinal implants consist of cobalt chromium alloys and titanium. In hip replacement surgery, there are many recent studies reporting elevated serum cobalt and chromium levels in metal-on-metal arthroplasties, which can be potentially dangerous. In spinal surgery, only cross-sectional studies have been carried out with regard to this phenomenon. However, elevated serum metal ion levels can be of importance, because exposure to nonphysiologic levels of chromium can result in genotoxicity, mutagenicity, impaired reproductive function, and infertility.
- Main changes (audit trail)
- RECORD22-jan-2016 - 20-mrt-2016

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