An observational study in Spondylosis, Cervical Spondylosis and Spondylolisthesis, sponsored by Elutia Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Elutia Inc. · Observational
Among 102 studies in Spondylolisthesis with a site in United States — 14 open to participants now, 19 under way, none of them phase 3. Spondylolisthesis · United States.
Among the 102 studies in Spondylolisthesis with a site in United States, this one is the 19th largest by enrollment of the 38 observational ones that give a count, is one of 6 that started in 2018, is one of 38 observational ones, and was the 57th registered.
227 studies on the registry are indexed under Spondylolisthesis; 43 are open to participants now.
Browse Spondylolisthesis studies →14 of the 102 studies in Spondylolisthesis with a site in United States are open now. Recruiting first, the newest first:
Stanford University · Sites in United States
Spinal Simplicity LLC · Sites in United States
Alphatec Spine, Inc. · Sites in United States
Bioventus LLC · Sites in United States
Francis Farhadi · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 27 Spondylolisthesis studies recruiting now, 11 (41%) set no upper age limit and 8 (30%) stop at 75 or younger; 7 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
102 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 6 · Phase 3 5 · Phase 4 8
First in 2000; this study’s year is marked. 6 started in 2018.
This study's enrollment of 118 is close to the median of 108 across 79 observational studies indexed under Spondylolisthesis.
Median enrollment 50 across the 64 interventional studies, 114 across the 38 observational. Of the 66 that completed or were terminated, 20 (30%) have results posted.
This tab as a report to print or save as PDF → With an account.
57 of 102 have an industry lead sponsor. The 10 most frequent:
Elutia Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.
Elutia Inc. has 2 studies filed under Spondylolisthesis — fewer than ten, so there is no comparison to draw.
6 of the studies in Spondylolisthesis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05691062Twin Cities Spine CenterTitanium vs. PEEK Fusion Devices in 1 Level TLIF | 2027-01-11 |
| NCT05029726John O'TooleRegional Anesthesia in Minimally Invasive Lumbar Spine Surgery | 2027-02-01 |
| NCT06093477Stanford UniversityStudying Melatonin and Recovery in Teens | 2027-06-01 |
| NCT04204135Rush University Medical CenterThe Course of Hip Flexion Weakness Following LLIF or ALIF | 2027-09-04 |
| NCT07766824National University of Natural MedicineEvaluation of an Online Peri-operative Health Education Platform for Patients Undergoing Spine Surgery: Ready Set Recover | 2027-09-30 |
Among the 102 studies in Spondylolisthesis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
227 studies on the registry are indexed under Spondylolisthesis; 43 are open to participants now.
This study's enrollment of 118 is close to the median of 108 across 79 observational studies indexed under Spondylolisthesis.
Browse Spondylolisthesis studies →Elutia Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.
Compared within Spondylolisthesis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Spondylosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled.
Other: ViBone
Patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled.
Other: ViBone
Viable Bone Allograft
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
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
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
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
| Milestone | Cervical Fusion - ACDF | Lumbar Interbody Fusion |
|---|---|---|
| Started | 54 | 64 |
| Completed | 48 | 47 |
| Not completed | 6 | 17 |
| Withdrew: Lost to follow-up | 2 | 4 |
| Withdrew: Withdrawal by subject | 0 | 3 |
| Withdrew: Subject did not meet i/e | 4 | 10 |
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.
| Fusions | Cervical Fusion - ACDF | Lumbar Interbody Fusion |
|---|---|---|
| Fusion Rates Per Level Using the Bridwell Interbody Grading Scale | 64 | 50 |
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 in ODI from baseline | Cervical Fusion - ACDF | Lumbar Interbody Fusion |
|---|---|---|
| Percent Change From Baseline in Oswestry Disability Index (ODI) at 12 Months | — | -50.6 ± 55.9 |
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 in NDI from baseline | Cervical Fusion - ACDF | Lumbar Interbody Fusion |
|---|---|---|
| Percent Change From Baseline in Neck Disability Index (NDI) at 12 Months | -41.9 ± 35.2 | — |
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)
| Percent Change from baseline | Cervical Fusion - ACDF | Lumbar Interbody Fusion |
|---|---|---|
| Percent Change From Baseline in Visual Analog Scale (VAS) at 12 Months | -40.1 ± 41.5 | -57.5 ± 44.2 |
Collected over Adverse event information was collected for up to 1 year.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cervical Fusion - ACDF | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) |
| Lumbar Interbody Fusion | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
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).
| Age, Continuous(years) | Cervical Fusion - ACDF | Lumbar Interbody Fusion | Total |
|---|---|---|---|
| Mean | 54.6 ± 9.1 | 57.8 ± 9.5 | 56.2 ± 9.4 |
| Sex: Female, Male(Participants) | Cervical Fusion - ACDF | Lumbar Interbody Fusion | Total |
|---|---|---|---|
| Female | 23 | 24 | 47 |
| Male | 25 | 23 | 48 |
| Race/Ethnicity, Customized(Participants) | Cervical Fusion - ACDF | Lumbar Interbody Fusion | Total |
|---|---|---|---|
| Race/Ethnicity — White | 25 | 35 | 60 |
| Race/Ethnicity — Hispanic or Latino | 15 | 10 | 25 |
| Race/Ethnicity — Black or African American | 4 | 2 | 6 |
| Race/Ethnicity — Other | 4 | 0 | 4 |
| BMI, Continuous(kg/m²) | Cervical Fusion - ACDF | Lumbar Interbody Fusion | Total |
|---|---|---|---|
| Mean | 27.9 ± 5.7 | 29.8 ± 5.2 | 28.8 ± 5.5 |
| BMI, Categorical(Participants) | Cervical Fusion - ACDF | Lumbar Interbody Fusion | Total |
|---|---|---|---|
| Normal (18.5 - <25.0) | 15 | 6 | 21 |
| Overweight (25.0 - <30.0) | 17 | 25 | 42 |
| Obese (30.0 - <40.0) | 16 | 14 | 30 |
| Morbidly Obese (>/=40.0) | 0 | 2 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2018 to primary completion in Jan 2021, 32 months.
Results were first posted in Mar 2025, 4 years 1 month after primary completion.
Of 37 observational studies under Spondylolisthesis, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 93. This study's 32 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Elutia Inc.