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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT01402167
Eligibility Criteria:
Inclusion Criteria:
* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 3 months of follow-up
* Fracture type according to Magerl Classification (1994) must be one of the following: A1, A2.1, A3.1, A3.2
* Cyphose of \>10°
* Spinal pain
* Vertebral fracture \< 3 weeks old located between D5 and L5
* If fragments in the canal, they must protrude less than 40%
* Absence of other lesions, including cancer
Exclusion Criteria:
* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Patient cannot read French
* Patient is pregnant or breast feeding
* Patient has a fracture on an adjacent vertebra
* Patient has a contra-indication for a treatment used in this study
* ASA class IV or V
* Patient has a neurological deficit
* Previous spinal surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01402167
Study Brief:
Protocol Section:
NCT01402167