Lumbar SpondylolisthesisViviGenNCT03733626

Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease

A study testing ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system and Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system in people with Lumbar Spondylolisthesis and Degenerative Disc Disease, run by Corewell Health East at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Lumbar Spondylolisthesis, Degenerative Disc Disease, Degenerative Spondylolisthesis
What is being tested?: ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system and Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 1 siteUnited States
Study dates: 19 Mar 2019to 25 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

≥18 years of age
Able to provide consent
Is undergoing standard of care one or two-level instrumented posterolateral fusion at the level between L1-S1
Has diagnosis of spinal stenosis, degenerative disc disease and/or up to Grade 1 spondylolisthesis
Requires decompression at intended fusion level (multi-level decompression allowed L1-S1)
Has failed 6-weeks or more of conservative, non-operative treatment
Has back and/or radicular lumbar symptoms with ODI score of ≥ 30 preoperatively.

Who cannot join

Any prior lumbar fusion surgery
Requires fusion of more than two levels
Requires an interbody fusion based on relevant diagnoses and factors (such as foraminal stenosis, degree of spondylolisthesis, spinal deformity, disc space collapse, and subject's age) as determined by investigator
BMI > 40
Active systemic infection or infection at operative site
History of an osteoporotic fracture and/or vertebral body fracture

Show all 12Show fewer

Is currently being treated with chemotherapy, radiation, immunosuppression or chronic steroid therapy
History of osteoporosis, osteopenia, or osteomalacia that would contraindicate spinal surgery
Psychological or physical condition in the opinion of the investigator that would interfere with subject self-assessments
History of neurological condition in the opinion of the investigator that may affect lumbar function and pain assessments
Subjects with a history of cancer must be disease free for at least 3 years
Pregnant, or plans on becoming pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

William Beaumont Hospital
Royal Oak, Michigan, 48073

Other trials in United States

About this study

Official title: Clinical Outcomes Associated With the Use of ViviGen® in Conjunction With Posterolateral Fusion for the Treatment of Lumbar Degenerative Disc Disease

The objective of this study is to perform a prospective, randomized, controlled clinical trial to compare radiographic fusion rates and patient reported outcomes, including pain and function preoperatively and postoperatively, using Depuy ViviGen® Cellular Bone Matrix mixed with cortical/cancellous allograft in conjunction with an approved Depuy Synthes pedicle screw system compared to autograft mixed with cortical/cancellous allograft in conjunction with the same DePuy Synthes pedicle screw system used for a one or two - level posterolateral lumbar fusion.

Read the detailed description

This is a prospective randomized, non-blinded, controlled study. Patients with a diagnosis of degenerative disc disease and/or up to grade I spondylolisthesis and planning to undergo a one or two-level instrumented posterolateral lumbar fusion surgery between L1-S1 will be screened. If eligible and the subject meets all the inclusion criteria and none of the exclusion criteria, the subject will be approached about study participation by the surgeon. If the subject agrees to participate, the consent process will be initiated by the study coordinator. Once the patient has been consented; data including medical history, neurological exam, patient questionnaires (visual analogue pain score (VAS), Oswestry low-back disability questionnaire (ODI), short form health survey (SF-36)) will be collected. Randomization will occur once a surgery date has been scheduled so the appropriate instrumentation can be boarded accordingly. A randomization envelope will reveal randomization treatment group. The envelopes will be generated in a 1:1 fashion and be randomly allocated to an assigned study identification number.

Subjects will be randomized to either: 1) treatment arm where the investigator will use an FDA approved/cleared DePuy Synthes spinal pedicle screw system with ViviGen® Cellular Bone Matrix mixed with cortical/cancellous allograft or the 2) control arm where the investigator use the same DePuy Synthes spinal pedicle screw system with local autologous bone graft mixed with cortical/cancellous allograft. Both treatment groups represent standard of care lumbar fusion surgeries using two types of bone graft options to create the arthrodesis as comparators.

Once the lumbar fusion surgery has taken place as planned; data will be collected regarding the surgery performed, including operative time, amount of bone graft used, spinal system used, length of hospital stay, and adverse events/complications.

Study subjects will be followed up at 6-weeks, 3-months, 6-months, and 12-months postoperatively at the private practice or clinic. During these routine (standard of care) postoperative visits, subjects will complete questionnaires (VAS, ODI, SF-36, patient satisfaction) and have neurological exam (lumbar spine exam, see appendix 1) completed by the investigator. Adverse events related to device and/or procedure will be evaluated as each postoperative visit. Anteroposterior (AP) and lateral x-rays will be performed at all visits with flexion and extension x-rays added at baseline, 3-months, 6-months, and 12-months. A CT scan of the lumbar spine will be performed during the 12-month postoperative time frame at the Beaumont-Royal Oak Imaging Center. Radiographic analysis will be performed and evaluated for fusion status as evidenced by bony bridging, presence of radiolucency, and development of pseudoarthrosis at each follow-up visit.

This study design reflects the current standard of care for lumbar spinal stenosis, degenerative disc disease and lumbar degenerative spondylolisthesis. Lumbar fusion surgery using pedicle screw fixation with autograft and allograft bone grafting options is treatment of choice after conservative (non-surgical) therapies have been implemented and failed.

Addendum:

In order to protect the well-being of patients and in compliance with the current state mandated shelter in place order, follow-up visits will be completed via telephone visit by the study coordinator when possible. This includes patient reported outcomes and adverse event reporting. Some parts of the study visit may not be completed over the phone such as lumbar x-rays, neuro exam, and CT scan (at 12-months postop); these missing (or scheduled at a later date) protocol specific items will be noted as a protocol deviation with the reason being due to COVID-19.
If a televisit is not possible, the visit may be rescheduled at a later date. Therefore, out of window and missing visits will be recorded as protocol deviations with the reason being due to COVID-19.
Subject follow-up visits will be rescheduled in the office once the acute phase of the pandemic has subsided if the study visit is not substantially out of window.
Subject enrollment is on hold until the acute phase of the pandemic has subsided but screening will continue.

Conditions: Lumbar Spondylolisthesis, Degenerative Disc Disease, Degenerative Spondylolisthesis, Lumbar Radiculopathy, Lumbar Spinal Stenosis, Lumbar Disc Disease
Being tested: ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system, Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system
Medical subject headings: Spondylolisthesis, Intervertebral Disc Degeneration, Radiculopathy, Spinal Stenosis, Intervertebral disc disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw systemCombination product
Also called ViviGen® Cellular Bone Matrix
ViviGen® is manufactured by LifeNet Health. ViviGen® Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone. ViviGen is a Human Cells, Tissues, and Cellular and Tissue-based Product (HCT/P) as defined by the U.S. Food and Drug Administration in 21 CFR 1271.10 and will be used with the FDA approved DePuy Synthes Spinal pedicle screw system for fusion.
Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw systemCombination product
Also called Local Bone Autologous Bone Graft
Patient's own bone harvested during spinal surgery will be used with the FDA approved DePuy Synthes spinal pedicle screw system to create the fusion.

Study groups in NCT03733626
Study group	Role	What they receive
ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle Screw System	Active comparator	20 subjects undergoing one or two-level instrumented posterolateral lumbar fusion surgery using ViviGen Cellular Bone Matrix mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system Receives: Combination Product: ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system
Local Bone Autograft with DePuy Synthes Spinal Pedicle Screw System	Placebo comparator	20 subjects undergoing open, one or two-level posterolateral lumbar fusion surgery using local autograft mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system. Receives: Combination Product: Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Successful Lumbar Fusion Measured Radiographically
Count of participants with successful lumbar bone fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no presence of radiolucency and no development of pseudoarthrosis at the treated lumbar level
Measured: 12 months postoperative

Secondary outcomes (6)

Visual Analog Scale for Pain
Number of participants achieving equal to or greater than a 2-point decrease in patient reported outcomes as measured by Visual Analog Scale for pain (0-10 point scale, 0 = no pain and 10 = severe amount of pain) from baseline to 12-months, representing a decrease in pain.
Measured: 12 months postoperative
Change in Oswestry Disability Index for Pain and Function
Number of participants achieving equal to or greater than 15-point decrease in patient reported outcomes as measured by Oswestry Disability Index (0-100 point scale, 0 = least amount of disability, 100 = most severe disability) from baseline to 12-months.
Measured: 12 months postoperative
Change in Short Form Health Survey-36 for Quality of Life: Physical Component Summary
Number of participants achieving equal to or greater than 15-point increase in patient reported quality-of-live outcomes as measured by a composite Physical Component Summary score on the SF-36 (0-100 point scale, 0 = low favorable health state and 100 = most favorable health state) from baseline to 12-months. This Physical Component Summary score is calculated by averaging scores from the Pain, Physical Functioning, Physical Role Limitation, and General Health Perception subscales for each patient at 12 months and at baseline, and calculating a difference. A positive number indicates an increase in physical health, and a negative number indicates a decrease in physical health.
Measured: 12 months postoperative
Neurological Deficit Per Lumbar Spine Neurological Exam
Count of participants with new or worsening neurological (lumbar motor and sensory) deficit as evaluated by lumbar spine neurological exam from baseline through 12 months.
Measured: 12 months postoperative
Count of Participants With Revision Surgery by Month 12
Count of participants with revision surgery by month 12
Measured: 12 months postoperative
Count of Participants Developing Pseudoarthrosis by Month 12
Count of participants developing pseudoarthrosis by month 12
Measured: 12 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 201925 Jun 2024

First posted7 Nov 2018
Study start19 Mar 2019
Primary completion25 Jun 2024
Study completion25 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Lumbar SpondylolisthesisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Subjects will be randomized to either: 1) treatment arm where the investigator will use an FDA approved/cleared DePuy Synthes spinal pedicle screw system with ViviGen® Cellular Bone Matrix mixed with cortical/cancellous allograft or the 2) control arm where the investigator use the same DePuy Synthes spinal pedicle screw system with local autologous bone graft mixed with cortical/cancellous allograft. Randomization is 1:1
Masking: Single blind
Who is masked: Participant
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03733626
Sponsor's protocol ID: 2018-158
Acronym: ViviGen
Status last verified: Jun 2025
First submitted: 30 Oct 2018
Last updated: 26 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Boden SD. Overview of the biology of lumbar spine fusion and principles for selecting a bone graft substitute. Spine (Phila Pa 1976). 2002 Aug 15;27(16 Suppl 1):S26-31. doi: 10.1097/00007632-200208151-00007.
PubMed 12205416
Kim DH, Rhim R, Li L, Martha J, Swaim BH, Banco RJ, Jenis LG, Tromanhauser SG. Prospective study of iliac crest bone graft harvest site pain and morbidity. Spine J. 2009 Nov;9(11):886-92. doi: 10.1016/j.spinee.2009.05.006. Epub 2009 Jun 18.
PubMed 19540168
Betz RR. Limitations of autograft and allograft: new synthetic solutions. Orthopedics. 2002 May;25(5 Suppl):s561-70. doi: 10.3928/0147-7447-20020502-04.
PubMed 12038843
Gazdag AR, Lane JM, Glaser D, Forster RA. Alternatives to Autogenous Bone Graft: Efficacy and Indications. J Am Acad Orthop Surg. 1995 Jan;3(1):1-8. doi: 10.5435/00124635-199501000-00001.
PubMed 10790647
DeCoster TA, Gehlert RJ, Mikola EA, Pirela-Cruz MA. Management of posttraumatic segmental bone defects. J Am Acad Orthop Surg. 2004 Jan-Feb;12(1):28-38. doi: 10.5435/00124635-200401000-00005.
PubMed 14753795
DePuy Synthes. https://www.depuysynthes.com/hcp/spine/products/qs/vivigen-cellular-bone-matrix. Copyright DePuy Synthes 2014-2017. DePuy Synthes Biomaterials Division 1302 Wrights Lane East, West Chester, Pennsylvania 19380.
Vaccaro AR, Stubbs HA, Block JE. Demineralized bone matrix composite grafting for posterolateral spinal fusion. Orthopedics. 2007 Jul;30(7):567-70. doi: 10.3928/01477447-20070701-06.
PubMed 17672157
Kang J, An H, Hilibrand A, Yoon ST, Kavanagh E, Boden S. Grafton and local bone have comparable outcomes to iliac crest bone in instrumented single-level lumbar fusions. Spine (Phila Pa 1976). 2012 May 20;37(12):1083-91. doi: 10.1097/BRS.0b013e31823ed817.
PubMed 22076647

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lumbar Spondylolisthesis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Outcomes Associated With the Use of ViviGen® in Conjunction With Posterolateral Fusion for the Treatment of Lumbar Degenerative Disc Disease
ClinicalTrials.gov ID: NCT03733626
Acronym / sponsor ID: ViviGen / 2018-158
Conditions: Lumbar Spondylolisthesis, Degenerative Disc Disease, Degenerative Spondylolisthesis, Lumbar Radiculopathy, Lumbar Spinal Stenosis, Lumbar Disc Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Corewell Health EastUniversity, hospital or other
Collaborators: DePuy Synthes
Study start: 19 Mar 2019 (actual)
Primary completion: 25 Jun 2024 (actual)
Study completion: 25 Jun 2024 (actual)
First posted: 7 Nov 2018 (actual)
Results: Posted 26 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Addendum:

In order to protect the well-being of patients and in compliance with the current state mandated shelter in place order, follow-up visits will be completed via telephone visit by the study coordinator when possible. This includes patient reported outcomes and adverse event reporting. Some parts of the study visit may not be completed over the phone such as lumbar x-rays, neuro exam, and CT scan (at 12-months postop); these missing (or scheduled at a later date) protocol specific items will be noted as a protocol deviation with the reason being due to COVID-19.
If a televisit is not possible, the visit may be rescheduled at a later date. Therefore, out of window and missing visits will be recorded as protocol deviations with the reason being due to COVID-19.
Subject follow-up visits will be rescheduled in the office once the acute phase of the pandemic has subsided if the study visit is not substantially out of window.
Subject enrollment is on hold until the acute phase of the pandemic has subsided but screening will continue.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Subjects will be randomized to either: 1) treatment arm where the investigator will use an FDA approved/cleared DePuy Synthes spinal pedicle screw system with ViviGen® Cellular Bone Matrix mixed with cortical/cancellous allograft or the 2) control arm where the investigator use the same DePuy Synthes spinal pedicle screw system with local autologous bone graft mixed with cortical/cancellous allograft. Randomization is 1:1

Arm	Type	Receives
ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle Screw System	Active comparator	Combination Product: ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system20 subjects undergoing one or two-level instrumented posterolateral lumbar fusion surgery using ViviGen Cellular Bone Matrix mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system
Local Bone Autograft with DePuy Synthes Spinal Pedicle Screw System	Placebo comparator	Combination Product: Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system20 subjects undergoing open, one or two-level posterolateral lumbar fusion surgery using local autograft mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

≥18 years of age
Able to provide consent
Is undergoing standard of care one or two-level instrumented posterolateral fusion at the level between L1-S1
Has diagnosis of spinal stenosis, degenerative disc disease and/or up to Grade 1 spondylolisthesis
Requires decompression at intended fusion level (multi-level decompression allowed L1-S1)

Key exclusion criteria (12 listed)

Any prior lumbar fusion surgery
Requires fusion of more than two levels
Requires an interbody fusion based on relevant diagnoses and factors (such as foraminal stenosis, degree of spondylolisthesis, spinal deformity, disc space collapse, and subject's age) as determined by investigator
BMI > 40
Active systemic infection or infection at operative site

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw systemAlso: ViviGen® Cellular Bone MatrixViviGen® is manufactured by LifeNet Health. ViviGen® Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone. ViviGen is a Human Cells, Tissues, and Cellular and Tissue-based Product (HCT/P) as defined by the U.S. Food and Drug Administration in 21 CFR 1271.10 and will be used with the FDA approved DePuy Synthes Spinal pedicle screw system for fusion.	Combination product	ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle Screw System
Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw systemAlso: Local Bone Autologous Bone GraftPatient's own bone harvested during spinal surgery will be used with the FDA approved DePuy Synthes spinal pedicle screw system to create the fusion.	Combination product	Local Bone Autograft with DePuy Synthes Spinal Pedicle Screw System

Primary outcome

Incidence of Successful Lumbar Fusion Measured Radiographically
Time frame: 12 months postoperative
Count of participants with successful lumbar bone fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no presence of radiolucency and no development of pseudoarthrosis at the treated lumbar level

6 secondary outcomes

Visual Analog Scale for Pain
Time frame: 12 months postoperative
Change in Oswestry Disability Index for Pain and Function
Time frame: 12 months postoperative
Change in Short Form Health Survey-36 for Quality of Life: Physical Component Summary
Time frame: 12 months postoperative
Neurological Deficit Per Lumbar Spine Neurological Exam
Time frame: 12 months postoperative
Count of Participants With Revision Surgery by Month 12
Time frame: 12 months postoperative
Count of Participants Developing Pseudoarthrosis by Month 12
Time frame: 12 months postoperative

Results and safety

Results posted to the registry on 26 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System	23	19
Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System	21	17

Primary outcome: Incidence of Successful Lumbar Fusion Measured Radiographically

Time frame: 12 months postoperative. Count of participants. Unit: Participants

Measure	ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System n = 19	Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System n = 17
Value	13	11

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System	1 of 19 (5.3%)	9 of 19 (47.4%)	0 of 19
Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System	0 of 17 (0%)	11 of 17 (64.7%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12205416Boden SD. Overview of the biology of lumbar spine fusion and principles for selecting a bone graft substitute. Spine (Phila Pa 1976). 2002 Aug 15;27(16 Suppl 1):S26-31. doi: 10.1097/00007632-200208151-00007.
Background: PubMed 19540168Kim DH, Rhim R, Li L, Martha J, Swaim BH, Banco RJ, Jenis LG, Tromanhauser SG. Prospective study of iliac crest bone graft harvest site pain and morbidity. Spine J. 2009 Nov;9(11):886-92. doi: 10.1016/j.spinee.2009.05.006. Epub 2009 Jun 18.
Background: PubMed 12038843Betz RR. Limitations of autograft and allograft: new synthetic solutions. Orthopedics. 2002 May;25(5 Suppl):s561-70. doi: 10.3928/0147-7447-20020502-04.
Background: PubMed 10790647Gazdag AR, Lane JM, Glaser D, Forster RA. Alternatives to Autogenous Bone Graft: Efficacy and Indications. J Am Acad Orthop Surg. 1995 Jan;3(1):1-8. doi: 10.5435/00124635-199501000-00001.
Background: PubMed 14753795DeCoster TA, Gehlert RJ, Mikola EA, Pirela-Cruz MA. Management of posttraumatic segmental bone defects. J Am Acad Orthop Surg. 2004 Jan-Feb;12(1):28-38. doi: 10.5435/00124635-200401000-00005.
BackgroundDePuy Synthes. https://www.depuysynthes.com/hcp/spine/products/qs/vivigen-cellular-bone-matrix. Copyright DePuy Synthes 2014-2017. DePuy Synthes Biomaterials Division 1302 Wrights Lane East, West Chester, Pennsylvania 19380.
Background: PubMed 17672157Vaccaro AR, Stubbs HA, Block JE. Demineralized bone matrix composite grafting for posterolateral spinal fusion. Orthopedics. 2007 Jul;30(7):567-70. doi: 10.3928/01477447-20070701-06.
Background: PubMed 22076647Kang J, An H, Hilibrand A, Yoon ST, Kavanagh E, Boden S. Grafton and local bone have comparable outcomes to iliac crest bone in instrumented single-level lumbar fusions. Spine (Phila Pa 1976). 2012 May 20;37(12):1083-91. doi: 10.1097/BRS.0b013e31823ed817.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jad G Khalil, MD principal investigator

Corewell Health East

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Successful Lumbar Fusion Measured Radiographically (time frame: 12 months postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03733626, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.