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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical Fusion - ACDF | Patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled. |
| |
| Lumbar Interbody Fusion | Patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ViBone | Other | Viable Bone Allograft |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 months |
| Percent Change From Baseline in Neck Disability Index (NDI) at 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spine Institute of San Diego | San Diego | California | 92120 | United States | ||
| Connecticut Neck & Back Specialists, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36964582 | Derived | Kim PD, Raiszadeh R, Bomback DA, Kramer DL, Moghimi M. 12-Month clinical and radiographic outcomes of ViBone viable bone matrix in patients undergoing cervical and lumbar spinal fusion surgery. J Orthop Surg Res. 2023 Mar 25;18(1):239. doi: 10.1186/s13018-023-03686-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervical Fusion - ACDF | Patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled. ViBone: Viable Bone Allograft |
| FG001 | Lumbar Interbody Fusion | Patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled. ViBone: Viable Bone Allograft |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
95 patients (48 cervical; 47 lumbar) were included in the data analyses because they met the inclusion criteria and had at least one follow-up (6- and/or 12-month).
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervical Fusion - ACDF | Patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled. ViBone: Viable Bone Allograft |
| BG001 | Lumbar Interbody Fusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Subjects with 12 month fusion by level data available | Posted | Count of Units | Fusions | 12 months | Fusions | Fusions |
|
Adverse event information was collected for up to 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cervical Fusion - ACDF | Patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled. ViBone: Viable Bone Allograft |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Operations | Aziyo Biologics, Inc. | 678-492-4712 | srichardson@aziyo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2019 | Feb 4, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055009 | Spondylosis |
| D013168 | Spondylolisthesis |
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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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. |
| Baseline and 12 months |
| 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) | Baseline and 12 months |
| Danbury |
| Connecticut |
| 06810 |
| United States |
| Anne Arundel Medical Group | Annapolis | Maryland | 21401 | United States |
| Orthopedic Specialists of Austin | Austin | Texas | 78751 | United States |
| Subject did not meet I/E |
|
Patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled.
ViBone: Viable Bone Allograft
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| BMI, Continuous | Mean | Standard Deviation | kg/m² |
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| BMI, Categorical | Count of Participants | Participants |
|
| OG001 | Lumbar Interbody Fusion | Patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled. ViBone: Viable Bone Allograft |
|
|
| 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. | ODI is not applicable to the cervical fusion arm. 25 subjects had baseline and 12 months data for ODI in the lumbar fusion arm. | Posted | Mean | Standard Deviation | Percent change in ODI from baseline | Baseline and 12 months |
|
|
|
| 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. | NDI is not applicable to the lumbar fusion arm. 33 subjects had NDI data at baseline and 12 months in the cervical fusion arm. | Posted | Mean | Standard Deviation | Percent change in NDI from baseline | Baseline and 12 months |
|
|
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| 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) | 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. | Posted | Mean | Standard Deviation | Percent Change from baseline | Baseline and 12 months |
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| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Lumbar Interbody Fusion | Patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled. ViBone: Viable Bone Allograft | 0 | 47 | 0 | 47 | 0 | 47 |
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