Lumbar Degenerative Disc Disease
Conditions
Brief summary
This study is a single-center, prospective randomized clinical study intended to compare and evaluate the efficacy of subjects who are treated with bone marrow aspirate concentrate (BMAC) and allograft to iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.
Detailed description
Subjects who are candidates for posterior lumbar or lumbosacral spinal fusion without anterior interbody support will be screened for inclusion in the study. Participants will be enrolled and randomized to either the BMAC + allograft or ICBG group. An enrollment ratio of two BMAC + allograft to one ICBG subject (2:1) for up to a total of 40 subjects will be enrolled in the study which also accounts for failed screening subjects. The study will determine and compare differences in fusion rate and health related quality of life parameters at 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively.
Interventions
PROCEDUREBMAC & Allograft
Use of Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest during posterior lumbar/lumbosacral spinal fusion.
PROCEDUREIliac Crest Bone Graft
Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be 18 years old or older * Scheduled for elective posterior spinal fusion of the thoracolumbar spine or lumbar spine with or without anterior interbody support * Failed at least 6 weeks of conservative care * ODI v2.1 score \> 30% * No contraindication to BMAC (as per manufacturer) * Signed consent form
Exclusion criteria
* Spondylolisthesis grade ≥ 3 * Pagets disease, osteomalacia, or any metabolic bone disease * Use of medications that interfere with bone healing (chronic steroids) * Patient unlikely to comply with post-op schedule with physician * Recent history of chemical dependency * Participation in other investigational device trial(s) within past 30 days * Active malignancy * Pregnancy or planning to become pregnant * Direct involvement in execution of this protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spinal Fusion Grade at 1 Year Via CT Scan | Post Operative 1 Year | Spinal fusion grade refers to the assessment of how well vertebrae fuse together after surgery, often evaluated using imaging like CT scans or radiographs. Grades typically range from complete fusion (Grade I) to non-union or pseudarthrosis (Grade IV), indicating varying degrees of bone healing and stability. |
| Change in Oswestry Disability Index (ODI) Score | Pre-operative, Post Operative 1 Year | The Oswestry Disability Index (ODI) score ranges from 0 to 100, with higher scores indicating greater disability. A score of 0% represents no disability, while a score of 100% represents complete disability. The ODI is often interpreted using categories: 0-20% (minimal disability), 21-40% (moderate disability), 41-60% (severe disability), 61-80% (crippling), and 81-100% (bedridden or functional impairment). |
| Short Form Health Survey (SF-12) | Pre-op, Post Operative 1 Year | The SF-12 is a shorter version of the SF-36, designed to assess health-related quality of life. Scores range from 0 to 100. Scores above 50 indicate better-than-average health-related quality of life for that component. Scores below 50 indicate below-average health-related quality of life. |
| Change in Numeric Pain Rating Scale Score From Baseline (Pre-op) and 1 Year Post Operative | Pre-op, Post Operative 1 Year | The numeric pain rating scale (NRS) is a tool used to assess pain intensity, commonly using a scale of 0 to 10, where 0 indicates "no pain" and 10 represents the "worst pain imaginable" |
| Length of Stay in Hospital, Measured in Days | Post Operative 1 Year | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPeter Passias, MD
NYU School of Medicine
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54.33 years STANDARD_DEVIATION 15.35 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 5 |
| other Total, other adverse events | 3 / 12 | 2 / 5 |
| serious Total, serious adverse events | 0 / 12 | 0 / 5 |
Outcome results
None listed