An interventional study of 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 Lumbar Spondylolisthesis, Degenerative Disc Disease and Degenerative Spondylolisthesis, sponsored by William Beaumont Hospitals. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by William Beaumont Hospitals · Not applicable, Interventional, and Treatment
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.
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:
227 studies on the registry are indexed under Spondylolisthesis; 43 are open to participants now.
This study's enrollment of 46 is below the median of 60 across 143 interventional studies indexed under Spondylolisthesis.
Browse Spondylolisthesis studies →William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Combination Product: ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system
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.
Combination Product: Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system
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.
Also known as: ViviGen® Cellular Bone Matrix
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.
Also known as: Local Bone Autologous Bone Graft
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
Time frame: 12 months postoperative
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months postoperative
Count of Participants With Revision Surgery by Month 12
Count of participants with revision surgery by month 12
Time frame: 12 months postoperative
Count of Participants Developing Pseudoarthrosis by Month 12
Count of participants developing pseudoarthrosis by month 12
Time frame: 12 months postoperative
2 patients were consented but screen failure prior to randomization, leaving 44 patients at start of study
| Milestone | ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System | Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System |
|---|---|---|
| Started | 23 | 21 |
| Completed | 19 | 17 |
| Not completed | 4 | 4 |
| Withdrew: Physician decision | 4 | 4 |
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
| Participants | ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System | Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System |
|---|---|---|
| Incidence of Successful Lumbar Fusion Measured Radiographically | 13 | 11 |
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.
| Participants | ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System | Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System |
|---|---|---|
| Visual Analog Scale for Pain | 13 | 12 |
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.
| Participants | ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System | Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System |
|---|---|---|
| Change in Oswestry Disability Index for Pain and Function | 13 | 11 |
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.
| Participants | ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System | Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System |
|---|---|---|
| Change in Short Form Health Survey-36 for Quality of Life: Physical Component Summary | 12 | 9 |
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.
| Participants | ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System | Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System |
|---|---|---|
| Neurological Deficit Per Lumbar Spine Neurological Exam | 2 | 2 |
Count of participants with revision surgery by month 12
| Participants | ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System | Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System |
|---|---|---|
| Count of Participants With Revision Surgery by Month 12 | 0 | 0 |
Count of participants developing pseudoarthrosis by month 12
| Participants | ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System | Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System |
|---|---|---|
| Count of Participants Developing Pseudoarthrosis by Month 12 | 0 | 1 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System | 0/19 (0%) | 1/19 (5.3%) | 9/19 (47.4%) |
| Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System | 0/17 (0%) | 0/17 (0%) | 11/17 (64.7%) |
| Event | ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System | Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System |
|---|---|---|
| Cardiac vessel occlusionCardiac disorders | 1/19 | 0/17 |
| Event | ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System | Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System |
|---|---|---|
| Back painMusculoskeletal and connective tissue disorders | 3/19 | 4/17 |
| Knee painMusculoskeletal and connective tissue disorders | 0/19 | 2/17 |
| Lower extremity numbness/weaknessNervous system disorders | 1/19 | 2/17 |
| FallInjury, poisoning and procedural complications | 1/19 | 2/17 |
| Lower extremity radiculopathyNervous system disorders | 2/19 | 0/17 |
| Sacroiliac joint painMusculoskeletal and connective tissue disorders | 0/19 | 1/17 |
| Pseuroarthrosis L4-5Musculoskeletal and connective tissue disorders | 0/19 | 1/17 |
| Hip painMusculoskeletal and connective tissue disorders | 0/19 | 1/17 |
| Synovial CystMusculoskeletal and connective tissue disorders | 0/19 | 1/17 |
| Dural Tear, intraoperativeInjury, poisoning and procedural complications | 0/19 | 1/17 |
| Age, Continuous(years) | ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System | Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System | Total |
|---|---|---|---|
| Mean | 61.2 ± 10.5 | 59.8 ± 11.3 | 60.5 ± 6.6 |
| Sex: Female, Male(Participants) | ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System | Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System | Total |
|---|---|---|---|
| Female | 11 | 9 | 20 |
| Male | 8 | 8 | 16 |
| Ethnicity (NIH/OMB)(Participants) | ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System | Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 19 | 17 | 36 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System | Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 16 | 14 | 30 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | ViviGen® Cellular Bone Matrix With DePuy Synthes Spinal Pedicle Screw System | Local Bone Autograft With DePuy Synthes Spinal Pedicle Screw System | Total |
|---|---|---|---|
| United States | 19 | 17 | 36 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2019 to primary completion in Jun 2024, 63 months.
Results were first posted in Jun 2025, 1 year after primary completion.
Of 42 non-industry interventional studies with no phase under Spondylolisthesis, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 63. This study's 63 months is above that.
Counting every sponsor, half of 61 studies reached it within 46 months; a quarter within 16 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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