Clinical trial NCT03425682: ViBone in Cervical and Lumbar Spine Fusion
Official title: A Prospective, Post-Market, Multi-Center Study Evaluating ViBone® in Cervical and Lumbar Spine Fusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondylosis
Cervical Spondylosis
Spondylolisthesis
Herniated Nucleus Pulposus
Degenerative Disc Disease
Keywords: Anterior Cervical Discectomy and Fusion (ACDF)
Transforaminal Lumbar Interbody Fusion (TLIF)
Posterior Lumbar Interbody Fusion (PLIF)
Lead sponsor: Elutia Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-07
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients, 18-80 years of age undergoing 1-3 level anterior cervical discectomy fusion (ACDF), or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fusion Rates Per Level Using the Bridwell Interbody Grading Scale
timeFrame: 12 months
Secondary outcomes:
measure: Percent Change From Baseline in Oswestry Disability Index (ODI) at 12 Months
timeFrame: Baseline and 12 months
measure: Percent Change From Baseline in Neck Disability Index (NDI) at 12 Months
timeFrame: Baseline and 12 months
measure: Percent Change From Baseline in Visual Analog Scale (VAS) at 12 Months
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Spine Institute of San Diego
state: California
city: Danbury
country: United States
facility: Connecticut Neck & Back Specialists, LLC
state: Connecticut
city: Annapolis
country: United States
facility: Anne Arundel Medical Group
state: Maryland
city: Austin
country: United States
facility: Orthopedic Specialists of Austin
state: Texas
Study officials:
References: