ViBone in Cervical and Lumbar Spine Fusion

Elutia Inc.

Status

Completed

Conditions

Degenerative Disc Disease

Cervical Spondylosis

Spondylolisthesis

Herniated Nucleus Pulposus

Spondylosis

Treatments

Other: ViBone

Study type

Observational

Funder types

Industry

Identifiers

NCT03425682

CLP-0001

Details and patient eligibility

About

Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.

Full description

This study is a prospective, multi-center study to evaluate the clinical and radiographic outcomes of ViBone in patients undergoing ACDF or lumbar interbody fusion. Data will be gathered for subjects undergoing ACDF surgery and subjects undergoing lumbar fusion surgery using ViBone. Total enrollment is expected to be approximately 100 subjects. The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo 1-3 level ACDF or lumbar interbody fusion surgery using ViBone. Subjects will be followed for 12 months following surgery.

Enrollment

118 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female, 18-80 years of age
For cervical cases - ACDF surgery at 1, 2, or 3 contiguous levels between C2-C7
For lumbar cases - lumbar interbody fusion surgery at 1, 2, or 3 contiguous levels between L1-S1
Patient signed Consent Form with HIPAA Authorization
Appropriate candidate for surgery
Patient will adhere to the scheduled follow-up visits and requirements of the protocol including routine patient exams - pre-operative, operative, and at least two post- operative visits (6 and 12 months post-surgery). Pre-operative and post-operative visits include X-ray (required) and CT scan (if available).

Exclusion criteria

Long term use of medications that are known to inhibit fusion or bone metabolism or immune suppressants 6 months prior to surgery (i.e., steroids, chemotherapy, DMARDs, etc.)
Treatment with radiotherapy
Acute or chronic systemic or localized spinal infections
Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical (for ACDF patients) or lumbar (for TLIF, PLIF, ALIF, or LLIF patients) spine
Previous pseudoarthrosis at any level of the cervical (for ACDF patients) or lumbar (for
TLIF, PLIF, ALIF, or LLIF patients) spine
Nursing mothers or women who are pregnant or plan to become pregnant during the course of the study
Current or recent history of malignancy or infectious disease. Patients with current or recent history of basal cell carcinoma are eligible.
Inability to provide informed consent
Rapid joint disease, bone absorption, osteomalacia, and/or diagnosed osteoporosis (bone density score of ≤-2.5).
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.
Active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection.