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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT04615260
Eligibility Criteria:
Inclusion Criteria:
1. The individual has signed and dated a study specific informed consent form approved by the Institutional Review Board at UMMHC.
2. The individual is 18 to 85 years of age.
3. The individual is skeletally mature.
4. The individual has been diagnosed with 1 or 2 level degenerative disc disease or spondylolisthesis grade 1-3 with or without spinal stenosis, requiring posterolateral spinal fusion surgery with bone grafting.
5. The individual is physically and mentally willing and able to comply with the postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion Criteria:
1. The individual has had any previous attempts at fusion, at any lumbar levels.
2. The individual is morbidly obese (defined as 100 lbs over the recommended ideal weight as described in the Metropolitan Life Height and Weight Tables for Men and Women and or having a BMI \>39).
3. Patients with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
4. Patients with systemic collagen, bone or mineralization dysfunction (such as Paget's disease, osteogenesis imperfecta, Ehlers-Danlos Syndrome).
5. Patients who suffer from uncontrolled diabetes mellitus type I or insulin-dependent diabetes mellitus type II. (definition based on the glycosylated Haemoglobin level)
6. Patients who are suffering from autoimmune disease.
7. Patients who previously underwent chemotherapy, immunosuppressive disease or radiation to the local area.
8. Patients who received or are currently receiving corticosteroids (\> 2 years \> 5 mg prednisolone equivalent/d).
9. Patients with active local or systemic infection.
10. Patients with any known active malignancy.
11. Patients with other concurrent physical or mental conditions which are likely to affect their outcome.
12. Patient unable to consent for themselves
13. Pregnant women
14. Non-English speaking subjects. These subjects are excluded because they would not be able to complete the English-language surveys required during this study. Only English language versions of these surveys have been validated.
15. Prisoners
16. Patients less than 18 years old
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04615260
Study Brief:
Protocol Section:
NCT04615260