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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT03077204
Eligibility Criteria:
Inclusion Criteria
1. Age\>18 years
2. Scheduled 1 or 2-level ACDF spine surgery
3. The capacity to provide informed consent.
4. Subject has one or more of the following diagnoses:
1. Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Trauma (including fractures)
3. Tumors
4. Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
5. Pseudoarthrosis
6. Failed previous fusion
7. Decompression of the spinal cord following total or partial cervical vertebrectomy
8. Spondylolisthesis
9. Spinal stenosis
Exclusion Criteria Patients with any of the following conditions will be excluded, or if enrolled and found to be ineligible and do not fit the inclusion criteria, will be withdrawn from the study.
1. Patients with current or recent history of malignancy or infectious disease.
2. The inability to provide informed consent.
3. Subject has marked local inflammation
4. Subject has any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care.
5. Subject has a bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the devices.
6. Subject has bone abnormalities preventing safe screw fixation.
7. Subject has any open wounds.
8. Subject has rapid joint disease, bone absorption, osteopenia, osteomalacia, and/or osteoporosis. Osteoporosis or osteopenia are relative contraindications, since this condition may limit the degree of obtainable correction and/or the amount of mechanical fixation.
9. Subject has a documented or suspected metal sensitivity.
10. Subject is pregnant.
11. Subject has anatomical structures or physiological performance that would interfere with implant utilization.
12. Subject has inadequate tissue coverage over the operative site.
13. Subject has other medical or surgical conditions which would preclude the potential benefit of surgery, such as congenital abnormalities, immunosuppressive disease, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count.
14. Note: The Aviator Anterior Cervical Plating System is not approved or intended for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The surgeon must consider the levels of implantation, patient weight, patient activity level, and other patient conditions which may impact on the performance of the system.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03077204
Study Brief:
Protocol Section:
NCT03077204