Lumbar Spine Degeneration
Conditions
Brief 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.
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: 1. 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 2. Comparable inpatient length of stay (LOS) 3. 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 4. Comparable fusion rates, evaluated via CT scan I year postoperatively
Interventions
BIOLOGICAL5cc Vivigen and local autograft
The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
BIOLOGICALSmall kit rhBMP-2 with local autograft
The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
Sponsors
Virtua Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Masking description
The surgical team, including the surgeons, will be blinded to the treatment options until decompression/instrumentation have been completed. The patients and all staff, including hospital nursing staff, case management, and physical therapists, will be blinded as to which bone graft treatment the patient received.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 or older; 2. 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; 3. Willing to provide informed consent, participate in study, and comply with study protocol.
Exclusion criteria
1. Pregnant or contemplating pregnancy prior to surgery; 2. Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis); 3. Surgery involving more than 2 vertebral levels; 4. 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). 5. Lactating women 6. Patients who have a known or suspected allergy to Gentamicin Sulfate, Meropenem, Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin 7. Immune compromised patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Oswestry Disability Index (ODI) Score | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Inpatient Length of Stay | Average of 3 days in hospital | — |
| Fusion Rates, Evaluated Via CT Scan I Year Postoperatively | 1 year post surgery | — |
| Mean Postoperative Leg/Back Pain Score | Average of 3 days in hospital | Pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group - 5cc Vivigen and Local Autograft 5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft | 3 |
| Control Group - Small Kit rhBMP-2 With Local Autograft Small kit rhBMP-2 with local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft | 0 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
Baseline characteristics
| Characteristic | Total | Control Group - Small Kit rhBMP-2 With Local Autograft | Intervention Group - 5cc Vivigen and Local Autograft |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Continuous | 52.6 years | — | 53 years |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | — | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | — | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 0 |
| other Total, other adverse events | 0 / 3 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 |
Outcome results
Primary
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)
Time frame: Up to 1 year post surgery
Population: Patients did not attend every follow up visit and then were ultimately lost to follow up. Study was also terminated early when the PI left his practice so on patients were never randomized in the control group.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention Group - 5cc Vivigen and Local Autograft | Mean Oswestry Disability Index (ODI) Score | ODI at Two weeks | 78.5 score on a scale |
| Intervention Group - 5cc Vivigen and Local Autograft | Mean Oswestry Disability Index (ODI) Score | ODI at Six weeks | 42 score on a scale |
| Intervention Group - 5cc Vivigen and Local Autograft | Mean Oswestry Disability Index (ODI) Score | ODI at Three months | 36.6 score on a scale |
| Intervention Group - 5cc Vivigen and Local Autograft | Mean Oswestry Disability Index (ODI) Score | ODI at Six months | 36 score on a scale |
Secondary
Fusion Rates, Evaluated Via CT Scan I Year Postoperatively
Time frame: 1 year post surgery
Population: No patient returned for their 1 year post op scan
Secondary
Mean Inpatient Length of Stay
Time frame: Average of 3 days in hospital
Population: The study was terminated early before any patients were randomized to the control group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group - 5cc Vivigen and Local Autograft | Mean Inpatient Length of Stay | 1 days |
Secondary
Mean Postoperative Leg/Back Pain Score
Pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible
Time frame: Average of 3 days in hospital
Population: Study was terminated early before any patients were randomized to the control group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group - 5cc Vivigen and Local Autograft | Mean Postoperative Leg/Back Pain Score | 5.3 score on a scale |