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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT01751633
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65 years
* Diagnosis of single or multiple stable thoracolumbar fracture(s)
* Level T10- L3
* Type AO A3 or A4
* Radiologically confirmed by Rx or CT
* Fracture induced kyphotic deformity lower or equal to 20-35 degrees
* Definitive treatment (surgical or conservative) within 10 days after injury
* American Spinal Injury Association (ASIA) Impairment Scale = E (normal )
* Ability to understand patient information / informed consent form
* Willingness and ability to participate in the clinical investigation including imaging and follow-up procedures (FUs)
* Signed informed consent
Exclusion Criteria:
* Open fracture
* Polytrauma
* Pathologic fracture
* Disruption of the posterior ligamentous complex between T10 and L3
* Clinically evident osteoporosis as assessed by the investigator
* Spinal luxation
* Associated severe lesions as assessed by the investigator
* Spinal lesion due to gun or projectile
* Pre-existing spinal column deformity
* Prior spinal surgeries
* BMI \> 40 kg/m2
* Any severe medically not managed systemic disease
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reli-able assessment
* Pregnancy or women planning to conceive within the study period
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01751633
Study Brief:
Protocol Section:
NCT01751633