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:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT05448092
Eligibility Criteria:
Inclusion Criteria:
* undergoing an instrumented lumbar arthrodesis operation at 1, 2 or 3 levels.
* age between 18 and 75 years.
* agree of inclusion in the study with subscription of informed consent, available for 5 years follow-up, including phone interviews.
* availability of adequate preoperative radiological documentation: CT or MRI of the lumbar spine; standing lumbar spine x-ray performed in a neutral position in which the pelvic parameters (pelvic incidence, pelvic tilt) and all lumbar segments can be correctly assessed
* availability of adequate and comprehensive clinical information including the presence of preoperative ODI (Oswestry Disability Index) and SF-12.
* availability of adequate information regarding surgery
* availability of postoperative radiological documentation: lumbar spine X-ray with the same requirements as point 4 performed in the postoperative period and at 1 year follow-up.
* availability of adequate and comprehensive clinical information including ODI score (Oswestry Disability Index) and SF-12 questionnaire at follow-up. The minimum follow-up for each patient included must be 12 months, to be continued for a total of 5 years.
Exclusion Criteria:
* Patients who, although already enrolled, do not meet the inclusion criteria will be excluded.
* Patients who, regardless of age, have a life expectancy of less than 5 years due to associated diseases, must be excluded from the study.
* Patients who, for various reasons, have to withdraw their consent to be included in the study in writing will also be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05448092
Study Brief:
Protocol Section:
NCT05448092