Lumbar Spine DegenerationPhase 4NCT03527966
rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures
A Phase 4 study testing 5cc Vivigen and local autograft and Small kit rhBMP-2 with local autograft in people with Lumbar Spine Degeneration, run by Virtua Health, Inc. at 1 site in United States.
Trial summary
This study is aimed at comparing the overall efficacy (clinical and radiographic) of Vivigen, a novel cellular allograft product, and rhBMP-2 when utilized in lumbar fusion procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spine Degeneration
- What is being tested?
- 5cc Vivigen and local autograft and Small kit rhBMP-2 with local autograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2017to 27 Jul 2018
- Phase
- Phase 4
- 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
- Age 18 or older;
- Diagnosed with lumbar degenerative/isthmic spondylolisthesis, degenerative disc disease with axial low back pain and neurologic symptoms, failed conservative treatment and eligible for a single level lumbar instrumented fusion;
- Willing to provide informed consent, participate in study, and comply with study protocol.
Who cannot join
- Pregnant or contemplating pregnancy prior to surgery;
- Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);
- Surgery involving more than 2 vertebral levels;
- Worker's compensation or personal injury related to lumbar spine (treatment outcomes may be affected by patient's personal interests; could also run into potential issues with reimbursement).
- Lactating women
- Patients who have a known or suspected allergy to Gentamicin Sulfate, Meropenem, Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin
- Immune compromised patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Virtua Memorial Hospital
Mount Holly, New Jersey, 08060
About this study
Official title: rhBMP-2 Versus Vivigen, a Novel Cellular Allograft, in Lumbar Fusion Procedures: a Prospective Randomized Controlled Study
This study is aimed at comparing the overall efficacy (clinical and radiographic) of Vivigen, a novel cellular allograft product, and rhBMP-2 when utilized in lumbar fusion procedures.
Read the detailed description
The purpose of this study is to compare the overall efficacy (clinical outcome and radiographic fusion) of Vivigen (cellular allograft product) and rhBMP-2 in patients who undergo a single level lumbar instrumented fusion. Specifically, when compared to their control group counterparts treated to rhBMP-2, we hypothesize that the intervention group administered Vivigen would, following surgery, experience:
- Comparable mean postoperative leg/back pain score, where the pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible
- Comparable inpatient length of stay (LOS)
- Comparable postoperative Oswestry Disability Index (ODI) score (0-no disability, to 100-maximum disability possible), two weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively
- Comparable fusion rates, evaluated via CT scan I year postoperatively
- Conditions
- Lumbar Spine Degeneration
- Being tested
- 5cc Vivigen and local autograft, Small kit rhBMP-2 with local autograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5cc Vivigen and local autograftBiological
The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
Small kit rhBMP-2 with local autograftBiological
The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
| Study group | Role | What they receive |
|---|---|---|
| Intervention group - 5cc Vivigen and local autograft | Active comparator | Not described Receives: Biological: 5cc Vivigen and local autograft |
| Control group - small kit rhBMP-2 with local autograft | Active comparator | Not described Receives: Biological: Small kit rhBMP-2 with local autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Oswestry Disability Index (ODI) Score
The ODI is one of the most commonly utilized condition-specific measures of disability used in the management of spinal disorders (0-no disability, to 100-maximum disability possible)
Measured: Up to 1 year post surgery
Secondary outcomes (3)
Mean Postoperative Leg/Back Pain Score
Pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible
Measured: Average of 3 days in hospital
Mean Inpatient Length of Stay
Measured: Average of 3 days in hospital
Fusion Rates, Evaluated Via CT Scan I Year Postoperatively
Measured: 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start3 Jul 2017
- Primary completion27 Jul 2018
- Study completion27 Jul 2018
Why it stopped: PI left the institution
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.
- Other trials for Lumbar Spine DegenerationStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virtua Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527966
- Sponsor's protocol ID
- IRB G17008
- Status last verified
- Aug 2019
- First submitted
- 4 May 2018
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to disseminate study findings via conference representation and journal publication using de-identified analyzed data
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rhBMP-2 Versus Vivigen, a Novel Cellular Allograft, in Lumbar Fusion Procedures: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03527966
- Acronym / sponsor ID
- IRB G17008
- Conditions
- Lumbar Spine Degeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the institution
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Virtua Health, Inc.University, hospital or other
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Posted 7 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed at comparing the overall efficacy (clinical and radiographic) of Vivigen, a novel cellular allograft product, and rhBMP-2 when utilized in lumbar fusion procedures.
Detailed description
The purpose of this study is to compare the overall efficacy (clinical outcome and radiographic fusion) of Vivigen (cellular allograft product) and rhBMP-2 in patients who undergo a single level lumbar instrumented fusion. Specifically, when compared to their control group counterparts treated to rhBMP-2, we hypothesize that the intervention group administered Vivigen would, following surgery, experience:
- Comparable mean postoperative leg/back pain score, where the pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible
- Comparable inpatient length of stay (LOS)
- Comparable postoperative Oswestry Disability Index (ODI) score (0-no disability, to 100-maximum disability possible), two weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively
- Comparable fusion rates, evaluated via CT scan I year postoperatively
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group - 5cc Vivigen and local autograft | Active comparator | Biological: 5cc Vivigen and local autograft |
| Control group - small kit rhBMP-2 with local autograft | Active comparator | Biological: Small kit rhBMP-2 with local autograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older;
- Diagnosed with lumbar degenerative/isthmic spondylolisthesis, degenerative disc disease with axial low back pain and neurologic symptoms, failed conservative treatment and eligible for a single level lumbar instrumented fusion;
- Willing to provide informed consent, participate in study, and comply with study protocol.
Key exclusion criteria (7 listed)
- Pregnant or contemplating pregnancy prior to surgery;
- Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);
- Surgery involving more than 2 vertebral levels;
- Worker's compensation or personal injury related to lumbar spine (treatment outcomes may be affected by patient's personal interests; could also run into potential issues with reimbursement).
- Lactating women
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 |
|---|---|---|
| 5cc Vivigen and local autograftThe single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft | Biological | Intervention group - 5cc Vivigen and local autograft |
| Small kit rhBMP-2 with local autograftThe single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft | Biological | Control group - small kit rhBMP-2 with local autograft |
Primary outcome
Mean Oswestry Disability Index (ODI) Score
Time frame: Up to 1 year post surgery
The ODI is one of the most commonly utilized condition-specific measures of disability used in the management of spinal disorders (0-no disability, to 100-maximum disability possible)
3 secondary outcomes
Mean Postoperative Leg/Back Pain Score
Time frame: Average of 3 days in hospital
Mean Inpatient Length of Stay
Time frame: Average of 3 days in hospital
Fusion Rates, Evaluated Via CT Scan I Year Postoperatively
Time frame: 1 year post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Plan to disseminate study findings via conference representation and journal publication using de-identified analyzed data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5cc Vivigen and local autograft and Small kit rhBMP-2 with local autograft in people with Lumbar Spine Degeneration, run by Virtua Health, Inc. at 1 site in United States.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 28 Aug 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2019). 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?
Mean Oswestry Disability Index (ODI) Score (time frame: Up to 1 year post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2019.