Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT00931333
Eligibility Criteria:
Inclusion Criteria:
* Patients aged between 18 and 65 years old, BMI \< 30
* Stable and important fracture of the vertebral body between T9 and L5
* Diagnostic maximum 3 weeks after the trauma causing the fracture
* Type A1 to A3 (MAGERL scale) assessed by CT scan
* Lumbar local traumatic angle \> 10°, and thoracic \> 15°
* Given informed consent
* Patient with French health system
Exclusion Criteria:
* For women: no efficient contraception (intra uterine device, or contraceptive pill)
* Pregnant or feeding women
* Fractures due to metastasis or multiple myeloma
* Symptomatic compression of the spinal cord
* Multi site vertebroplasty
* Scoliosis with a Cobb angle \> 20°
* Surgery zone local infection
* All surgical contraindications
* Immune system abnormalities, immune deficiency or suppression, HIV or BHV or CHV (positive serology)
* Severe hyperparathyroidism: calcium \> 2,45 mmol/l and \[PTH\] ≥ 50pg / ml
* Uncontrolled diabetes (untreated or non stabilized by treatment)
* Long corticoid treatment (more than 6 months and stopped since less than 3 months)
* Chemotherapy
* All contra indication to MCPC: osteomyelitis, bone degenerative disease or necrosis of surgery site.
* Known allergy to indigotine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00931333
Study Brief:
Protocol Section:
NCT00931333