Clinical trial NCT02297256: Prospective Study of Thoracolumbar Spinal Fusion Graft
Official title: Prospective Study of Thoracolumbar Spinal Fusion Graft Efficacy: Bone Marrow Aspirate Concentrate Versus Iliac Crest Bone Graft
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lumbar Degenerative Disc Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: CT scan to assess fusion status
timeFrame: Pre-operative, Post Operative 1 Year
measure: Oswestry Disability Index (ODI)
timeFrame: Pre-operative, Post Operative 1 Year
measure: Short Form Health Survey (SF-12)
timeFrame: Pre-op, Post Operative 1 Year
measure: Numeric Pain Rating Scale
timeFrame: Pre-op, Post Operative 1 Year
measure: Length of Stay
timeFrame: Post Operative 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Hospital for Joint Diseases
state: New York
city: New York
country: United States
facility: Center for Musculoskeletal Care (CMC)
state: New York
city: Westbury
country: United States
facility: NY Spine Institute
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Peter Passias, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Asahara T, Masuda H, Takahashi T, Kalka C, Pastore C, Silver M, Kearne M, Magner M, Isner JM. Bone marrow origin of endothelial progenitor cells responsible for postnatal vasculogenesis in physiological and pathological neovascularization. Circ Res. 1999 Aug 6;85(3):221-8. doi: 10.1161/01.res.85.3.221.
citation: Gan Y, Dai K, Zhang P, Tang T, Zhu Z, Lu J. The clinical use of enriched bone marrow stem cells combined with porous beta-tricalcium phosphate in posterior spinal fusion. Biomaterials. 2008 Oct;29(29):3973-82. doi: 10.1016/j.biomaterials.2008.06.026. Epub 2008 Jul 18.