Multilevel instrumented posterolateral lumbar spine fusion with an allogeneic cellular bone graft

Abstract

BackgroundLow back pain (LBP) is the leading cause of absence from work, disability, and impaired quality of life. Fusion surgery may be indicated when non-operative treatments have failed to provide relief. Surgery may include the use of fusion-enhancing implants, such as cellular bone allografts (CBAs). The purpose of this retrospective study was to evaluate efficacy and safety of one CBA (V-CBA) in patients who underwent instrumented posterolateral fusion (IPLF).MethodsRetrospective data were collected from 150 consecutive patients who had undergone IPLF surgery between January 1, 2015, and March 31, 2018, in which V-CBA was used. All surgeries were performed by one surgeon. V-CBA was mixed with local autograft bone. Patient diagnoses included degenerative disc disease, spondylosis, spondylolisthesis, or spondylolysis with or without stenosis. Standing anteroposterior (AP) and lateral images were collected prior to surgery and again at the terminal visit, which took place between 6 and 33 months post-operatively. De-identified images were assessed radiologically. Adverse events were documented. The primary composite endpoint of fusion status was dependent upon two main criteria: bridging bone per the Lenke scale (classified as “A” definitely solid or “B” possibly solid) and posterior hardware status (intact). Lenke scale C or D were categorized as pseudarthrosis.ResultsEighty-seven male and 63 female patients (613 levels total) underwent IPLF in which V-CBA was implanted. An average of 4.1 levels was treated, with 59.3% of patients having undergone treatment for more than 3 levels. Twenty-nine percent of patients had diabetes. Fifty-two percent of patients had previously used nicotine products, and 12% were current smokers. Sixteen serious adverse events were recorded and included lumbar seroma, cerebrospinal fluid leak, wound dehiscence, pneumonia, urinary tract infection, and myocardial infarction. Successful fusion (Lenke scale “A” or “B”) was recorded in 148 out of 150 patients (98.7%), or 608 out of 613 levels. The total pseudarthrosis rate was 0.8%.ConclusionsThe use of V-CBA combined with local autograft in multilevel IPLF resulted in successful fusions in 98.7% of patients. These results are particularly robust given the complex nature of many of these cases: 89 patients had 4 or more surgical levels, and many patients had multiple comorbidities.Level of evidenceIV

A Large Database Study of Hospitalization Charges and Follow-up Re-admissions in Us Lumbar Fusion Surgeries Using a Cellular Bone Allograft (CBA) Versus Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)

“…and 270 (± 33.6) minutes in those using ICBG (average 1.98 levels treated) [26]. As noted by Hall, the use of V-CBA thus corresponded with an average of 37-and 59-minute faster surgeries than with rhBMP-2 and ICBG, respectively [16], in spite of the more-than-double average number of levels treated. Such disparities in operative time could potentially contribute to exponential differences in cost beyond those associated with direct costs and may partially explain the present results.…”

“…Additional costs could also be attributed to operating room time required for preparation of rhBMP-2 (≥ 15 minutes) versus VCBA (< 5 minutes), as well as that required for preparation of rhBMP-2 adjuncts (eg, spinning/prep of PRP). Supporting this possibility, a study by Hall and colleagues of multi-level instrumented posterolateral fusion (IPLF) surgeries using VCBA reported a mean operative time of 211.1 (± 87.3) minutes with an average of 4.1 levels treated [16]. Yet, Glassman and colleagues reported a mean operative time of 248 (± 58.5) minutes with IPLF surgeries using rhBMP-2 (average 1.96 levels treated)…”

“…Cellular bone allografts (CBAs) are another alternative, which theoretically contain osteoinductive, osteoconductive, and osteogenic properties [15,16]. In particular, a more recent advanced CBA comprised of viable cryopreserved lineage-committed boneforming cells (VCBA; marketed as ViviGen® by LifeNet Health®, Virginia Beach VA) uniquely emulates the bene ts of ICBG without its inherent drawbacks [16][17][18][19][20]. Unlike rhBMP-2, V-CBA can be used for homologous repair of any bone defect throughout the body [8,21].…”

“…Unlike rhBMP-2, V-CBA can be used for homologous repair of any bone defect throughout the body [8,21]. Clinical studies of spinal fusion surgeries using V-CBA have thus far reported successful fusion outcomes [16,17], and VCBA is potentially less expensive than rhBMP-2. However, no research to date has compared these two grafts on any level.…”

A Large Database Study of Hospitalization Charges and Follow-up Re-admissions in US Lumbar Fusion Surgeries Using a Cellular Bone Allograft (CBA) versus Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)

“…Cellular bone allografts (CBAs) are another alternative, which theoretically contain osteoinductive, osteoconductive, and osteogenic properties [15,16]. In particular, a more recent advanced CBA comprised of viable cryopreserved lineage-committed bone-forming cells (V-CBA; marketed as ViviGen® by LifeNet Health®, Virginia Beach VA) uniquely emulates the bene ts of ICBG without its inherent drawbacks [16][17][18][19][20]. Unlike rhBMP-2, V-CBA can be used for homologous repair of any bone defect throughout the body [8,21].…”