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 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT04629794
Eligibility Criteria:
Inclusion Criteria:
-≥18 years of age
* Indicated for deformity correction surgery
* Require spinal fusion at four or more levels
* Are willing to return for follow-up visits
* Willing to sign the Informed Consent Forms
Exclusion Criteria:
* Uncontrolled diabetes
* Morbid obesity
* history of alcohol or drug abuse
* Corticosteroid use
* Fever or leukocytosis
* Systemic infection
* Active malignancy
* Elevation of white blood cell count
* Osteoporosis
* Disease of bone metabolism
* Unsuitable or insufficient bone support
* Skeletal immaturity
* Prior fusion
* Use of steroids, immune suppressants, osteoporosis medications
* Use of internal bone stimulators
* Institutionalized or a prisoner
* Undergoing (Undergone) a worker's compensation case
* Pregnancy (includes women who are currently pregnant, lactating or wishing to become pregnant during the study duration)
* Participation in another research study involving another implant, product or drug that may affect the outcomes of this clinical study within the last 30 days, or planned during this clinical study
* Any other condition that the Investigator determines is unacceptable for enrollment into this clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04629794
Study Brief:
Protocol Section:
NCT04629794