Trial Outcomes & Findings for ViBone in Cervical and Lumbar Spine Fusion (NCT NCT03425682)

Last Updated: 2025-03-04

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

118 participants

Primary outcome timeframe

12 months

Results posted on

2025-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	Cervical Fusion - ACDF Patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled. ViBone: Viable Bone Allograft	Lumbar Interbody Fusion Patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled. ViBone: Viable Bone Allograft
Overall Study STARTED	54	64
Overall Study COMPLETED	48	47
Overall Study NOT COMPLETED	6	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Cervical Fusion - ACDF Patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled. ViBone: Viable Bone Allograft	Lumbar Interbody Fusion Patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled. ViBone: Viable Bone Allograft
Overall Study Lost to Follow-up	2	4
Overall Study Withdrawal by Subject	0	3
Overall Study Subject did not meet I/E	4	10

Baseline Characteristics

ViBone in Cervical and Lumbar Spine Fusion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cervical Fusion - ACDF n=48 Participants Patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled. ViBone: Viable Bone Allograft	Lumbar Interbody Fusion n=47 Participants Patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled. ViBone: Viable Bone Allograft	Total n=95 Participants Total of all reporting groups
Age, Continuous	54.6 years STANDARD_DEVIATION 9.1 • n=5 Participants	57.8 years STANDARD_DEVIATION 9.5 • n=7 Participants	56.2 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	25 Participants n=5 Participants	35 Participants n=7 Participants	60 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic or Latino	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
BMI, Continuous	27.9 kg/m² STANDARD_DEVIATION 5.7 • n=5 Participants	29.8 kg/m² STANDARD_DEVIATION 5.2 • n=7 Participants	28.8 kg/m² STANDARD_DEVIATION 5.5 • n=5 Participants
BMI, Categorical Normal (18.5 - <25.0)	15 Participants n=5 Participants	6 Participants n=7 Participants	21 Participants n=5 Participants
BMI, Categorical Overweight (25.0 - <30.0)	17 Participants n=5 Participants	25 Participants n=7 Participants	42 Participants n=5 Participants
BMI, Categorical Obese (30.0 - <40.0)	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
BMI, Categorical Morbidly Obese (>/=40.0)	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Subjects with 12 month fusion by level data available

Outcome measures

Outcome measures
Measure	Cervical Fusion - ACDF n=65 Fusions Patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled. ViBone: Viable Bone Allograft	Lumbar Interbody Fusion n=50 Fusions Patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled. ViBone: Viable Bone Allograft
Fusion Rates Per Level Using the Bridwell Interbody Grading Scale	64 Fusions	50 Fusions

SECONDARY outcome

Timeframe: 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.

Oswestry Disability Index (ODI) improvement relative to baseline for lumbar spine fusion (0-100) 0 is no disability and 100 is bed-bound.

Outcome measures

Outcome measures
Measure	Cervical Fusion - ACDF Patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled. ViBone: Viable Bone Allograft	Lumbar Interbody Fusion n=25 Participants Patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled. ViBone: Viable Bone Allograft
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cervical Fusion - ACDF n=33 Participants Patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled. ViBone: Viable Bone Allograft	Lumbar Interbody Fusion Patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled. ViBone: Viable Bone Allograft
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 outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Cervical Fusion - ACDF n=33 Participants Patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled. ViBone: Viable Bone Allograft	Lumbar Interbody Fusion n=25 Participants Patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled. ViBone: Viable Bone Allograft
Percent Change From Baseline in Visual Analog Scale (VAS) at 12 Months	-40.1 Percent Change from baseline Standard Deviation 41.5	-57.5 Percent Change from baseline Standard Deviation 44.2

Adverse Events

Cervical Fusion - ACDF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lumbar Interbody Fusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Associate Director, Clinical Operations

Aziyo Biologics, Inc.

Phone: 678-492-4712

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place