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.
ID
Bron
Verkorte titel
Aandoening
adolescent idiopathic scoliosis, spondylodesis, spinal fusion, idiopathische scoliose, spondylodese
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary study parameter is difference in coronal Cobb angles after two years of follow-up.
Achtergrond van het onderzoek
Surgical 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.
Doel van het onderzoek
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.
Onderzoeksopzet
pre-operatively, perioperatively, and postoperatively at 6 weeks, 3 months, 6 months, 1 year and 2 years.
Onderzoeksproduct en/of interventie
Surgical 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.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
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In overige registers
Register | ID |
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NTR-new | NL5552 |
NTR-old | NTR5674 |
CCMO | NL36436.078.11 |
OMON | NL-OMON43852 |