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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT02381067
Eligibility Criteria:
Inclusion Criteria:
1. Be at least 21 years of age
2. Have clinical and radiological evidence of degenerative disc disease, spondylosis, spinal stenosis, or spondylolisthesis at either one, two or three levels of cervical spine.
3. In the opinion of the treating surgeon, must already be a qualified candidate for cervical fusion surgery.
4. Be likely to return for regular follow-ups until the end of the study period.
5. Be willing and able to provide Informed Consent for study participation.
Exclusion Criteria:
1. Neck pain due to acute trauma.
2. Clinical, laboratory and/or radiological evidence of neck pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.).
3. Any terminal or autoimmune disease including but not limited to HIV infection, or rheumatoid arthritis.
4. Any other concurrent medical disease or treatment that might significantly impair normal healing process as evaluated by the PI.
5. Recent history (within past 6 months) of any chemical or alcohol dependence requiring treatment.
6. Currently a prisoner.
7. Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.
8. Pregnancy at the time of enrollment.
9. In order to confirm eligibility, subjects previously diagnosed with osteoporosis, osteopenia or osteomalacia, female subjects over the age of 65, post-menopausal female subjects under the age of 65 with any of the risk factors for osteoporosis, and subjects at the investigator's discretion will have DEXA scans performed prior to study entry. If DEXA is required, exclusion will be defined as a DEXA bone density measurement T score ≤ -2.5
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02381067
Study Brief:
Protocol Section:
NCT02381067