Status:
COMPLETED
ViBone in Cervical and Lumbar Spine Fusion
Lead Sponsor:
Elutia Inc.
Conditions:
Spondylosis
Cervical Spondylosis
Eligibility:
All Genders
18-80 years
Brief Summary
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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 14 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03425682
Start Date
May 14 2018
End Date
June 30 2021
Last Update
March 4 2025
Active Locations (4)
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1
Spine Institute of San Diego
San Diego, California, United States, 92120
2
Connecticut Neck & Back Specialists, LLC
Danbury, Connecticut, United States, 06810
3
Anne Arundel Medical Group
Annapolis, Maryland, United States, 21401
4
Orthopedic Specialists of Austin
Austin, Texas, United States, 78751