spinal deformity curved spine
Conditions
Interventions
MagnetOs Putty is a synthetic resorbable micro-structured bone void filler for the repair of bony defects. The product has a CE-mark as bone void filler. The carrier used in the putty formulation is a
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
12 Years to 64 Years
Inclusion criteria
Inclusion criteria: To be treated with instrumented posterolateral spinal fusion surgery because of adolescent idiopathic scoliosis; Major Cobb curve >45 degreesLowest instrumented vertebra between T12 and L4. If the axial slope of the superior facet joint T12 is judged to be more than 45 degrees intraoperatively (more horizontal like the thoracic vertebrae), the patient will be excluded peri-operatively and replaced Between 12 and 30 years of age at inclusion;Willing and able to understand and sign the patient informed consent (IC), and for 12–16-year-olds also parents’ IC;
Exclusion criteria
Exclusion criteria: Obvious non-idiopathic scoliosis: musculoskeletal or neurologic conditions causing the spinal curvature (e.g., neuromuscular, congenital, or syndromic scoliosis);Any previous surgical attempt(s) for spinal fusion (revision surgery) of the intended segment(s);Active spinal and/or systemic infection;Systemic disease or condition, which would affect the subject’s ability to participate in the study requirements or the ability to evaluate the efficacy of the graft (e.g., active malignancy, neuropathy);At risk to be non-compliant e.g.: likely to immigrate, (recently treated for) substance abuse, detainee;Participation in clinical trials evaluating treatments that may influence bone metabolism during the study or <3 months before surgery;Female patients who are pregnant or intend to be pregnant within 1 year of enrollment in the study (because of the CT scan);Obese patients (body mass index (BMI) >35);Being expected to require additional surgery to the same spinal region within the next 6 months;Current or recent (<1year) corticosteroid use equivalent to prednisone =5mg/day, prescribed for more than 6 weeks;Impossible to perform CT (e.g., claustrophobia);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The functioning and safety of the artificial bone are compared with the functioning and safety of native bone. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the spinal fusion rate at the lowest vertebra at 3 or 6 months for both MagnetOs™ Putty and own bone 2. To compare spinal fusion rate in the chestspine of MagnetOs™ Putty and no bone at 3 or 6 months 3. Monitoring the changes in trunk rotation over time 4. Evaluate health related quality of life, functioning, illness perception and patients’ perspectives with patient questionnaires 5. To compare patient experience between different post-operative rehabilitation policies with patient questionnaires 6. To assess and improve the reliability of Hounsfield units measurements on boneMRI by comparing to bone density on the 3- or 6-month CT scan 7. Evaluate fusion maturation at one year if applicable | — |
Countries
Netherlands
Contacts
Public ContactM.C. Kruijt
Universitair Medisch Centrum Utrecht
Outcome results
None listed