CR-16-109

About this trial

Last updated 4 years ago

Study ID

CR-16-109

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

Accepting

19+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 6 years ago

The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery. Specifically, the study aims to collect the data for ACDF model utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).

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conditions will be excluded, or if enrolled and found to be ineligible and do not fit the inclusion criteria, will be withdrawn from the study.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.

BIO4 Clinical Case Study: Cervical Spine