Cervical Spondylosis, Degenerative Disc Disease, Herniated Nucleus Pulposus, Spondylolisthesis, Spondylosis
Conditions
Keywords
Anterior Cervical Discectomy and Fusion (ACDF), Transforaminal Lumbar Interbody Fusion (TLIF), Posterior Lumbar Interbody Fusion (PLIF)
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.
Interventions
OTHERViBone
Viable Bone Allograft
Sponsors
Elutia Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion Rates Per Level Using the Bridwell Interbody Grading Scale | 12 months | Successful fusion rates for ViBone as defined by Grade I or II level of fusion on the Bridwell Interbody Grading Scale (below). The percentages below show at 12 months the amount of fusion per level for cervical and lumbar fusion procedures utilizing ViBone. Grade I: Fused with remodeling and trabeculae present. Grade II: Graft intact, not fully remodeled and incorporated, but no lucency present. Grade III: Graft intact, potential lucency present at top and bottom of graft. Grade IV: Fusion absent with collapse/resorption of graft. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Oswestry Disability Index (ODI) at 12 Months | Baseline and 12 months | Oswestry Disability Index (ODI) improvement relative to baseline for lumbar spine fusion (0-100) 0 is no disability and 100 is bed-bound. |
| Percent Change From Baseline in Neck Disability Index (NDI) at 12 Months | Baseline and 12 months | Neck Disability Index (NDI) improvement relative to baseline for cervical spine fusion Scale of 0 - 100, where 0 is no problems at all and 100 is severely affected. |
| Percent Change From Baseline in Visual Analog Scale (VAS) at 12 Months | Baseline and 12 months | Visual Analog Scale (VAS) for pain improvement relative to baseline (Pain scale from 0-10, with 0 being No Pain and 10 being Worst Pain) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cervical Fusion - ACDF Patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled.
ViBone: Viable Bone Allograft | 48 |
| Lumbar Interbody Fusion Patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled.
ViBone: Viable Bone Allograft | 47 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Subject did not meet I/E | 4 | 10 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Cervical Fusion - ACDF | Lumbar Interbody Fusion | Total |
|---|---|---|---|
| Age, Continuous | 54.6 years STANDARD_DEVIATION 9.1 | 57.8 years STANDARD_DEVIATION 9.5 | 56.2 years STANDARD_DEVIATION 9.4 |
| BMI, Categorical Morbidly Obese (>/=40.0) | 0 Participants | 2 Participants | 2 Participants |
| BMI, Categorical Normal (18.5 - <25.0) | 15 Participants | 6 Participants | 21 Participants |
| BMI, Categorical Obese (30.0 - <40.0) | 16 Participants | 14 Participants | 30 Participants |
| BMI, Categorical Overweight (25.0 - <30.0) | 17 Participants | 25 Participants | 42 Participants |
| BMI, Continuous | 27.9 kg/m² STANDARD_DEVIATION 5.7 | 29.8 kg/m² STANDARD_DEVIATION 5.2 | 28.8 kg/m² STANDARD_DEVIATION 5.5 |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic or Latino | 15 Participants | 10 Participants | 25 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 25 Participants | 35 Participants | 60 Participants |
| Sex: Female, Male Female | 23 Participants | 24 Participants | 47 Participants |
| Sex: Female, Male Male | 25 Participants | 23 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 47 |
| other Total, other adverse events | 0 / 48 | 0 / 47 |
| serious Total, serious adverse events | 0 / 48 | 0 / 47 |
Outcome results
Primary
Fusion Rates Per Level Using the Bridwell Interbody Grading Scale
Successful fusion rates for ViBone as defined by Grade I or II level of fusion on the Bridwell Interbody Grading Scale (below). The percentages below show at 12 months the amount of fusion per level for cervical and lumbar fusion procedures utilizing ViBone. Grade I: Fused with remodeling and trabeculae present. Grade II: Graft intact, not fully remodeled and incorporated, but no lucency present. Grade III: Graft intact, potential lucency present at top and bottom of graft. Grade IV: Fusion absent with collapse/resorption of graft.
Time frame: 12 months
Population: Subjects with 12 month fusion by level data available
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Cervical Fusion - ACDF | Fusion Rates Per Level Using the Bridwell Interbody Grading Scale | 64 Fusions |
| Lumbar Interbody Fusion | Fusion Rates Per Level Using the Bridwell Interbody Grading Scale | 50 Fusions |
Secondary
Percent Change From Baseline in Neck Disability Index (NDI) at 12 Months
Neck Disability Index (NDI) improvement relative to baseline for cervical spine fusion Scale of 0 - 100, where 0 is no problems at all and 100 is severely affected.
Time frame: Baseline and 12 months
Population: NDI is not applicable to the lumbar fusion arm. 33 subjects had NDI data at baseline and 12 months in the cervical fusion arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cervical Fusion - ACDF | Percent Change From Baseline in Neck Disability Index (NDI) at 12 Months | -41.9 Percent change in NDI from baseline | Standard Deviation 35.2 |
Secondary
Percent Change From Baseline in Oswestry Disability Index (ODI) at 12 Months
Oswestry Disability Index (ODI) improvement relative to baseline for lumbar spine fusion (0-100) 0 is no disability and 100 is bed-bound.
Time frame: Baseline and 12 months
Population: ODI is not applicable to the cervical fusion arm. 25 subjects had baseline and 12 months data for ODI in the lumbar fusion arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumbar Interbody Fusion | Percent Change From Baseline in Oswestry Disability Index (ODI) at 12 Months | -50.6 Percent change in ODI from baseline | Standard Deviation 55.9 |
Secondary
Percent Change From Baseline in Visual Analog Scale (VAS) at 12 Months
Visual Analog Scale (VAS) for pain improvement relative to baseline (Pain scale from 0-10, with 0 being No Pain and 10 being Worst Pain)
Time frame: Baseline and 12 months
Population: VAS-pain scores were available at baseline and 12 months for 33 subjects in the cervical fusion arm and 25 subjects in the lumbar fusion arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cervical Fusion - ACDF | Percent Change From Baseline in Visual Analog Scale (VAS) at 12 Months | -40.1 Percent Change from baseline | Standard Deviation 41.5 |
| Lumbar Interbody Fusion | Percent Change From Baseline in Visual Analog Scale (VAS) at 12 Months | -57.5 Percent Change from baseline | Standard Deviation 44.2 |