Living Cryopreserved Bone Allograft as an Adjunct for Hindfoot Arthrodesis

Magnus, Mark K.; Iceman, Kelli L.; Roukis, Thomas S.

doi:10.1016/j.cpm.2018.02.002

Cited by 9 publications

(8 citation statements)

References 30 publications

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“…30,31 Although other allogenic cellular bone matrix products containing MSCs have been described in the literature for use in foot and ankle procedures, the use of ViviGen for foot and ankle procedures has only been described in a few published cases, all of which showed adequate safety and efficacy. 18,[32][33][34] The results of these limited reports support continued research into the clinical use of allogenic cellular bone matrix products for foot and ankle procedures.…”

Section: Discussionmentioning

confidence: 86%

A Retrospective Analysis of Outcomes From Foot and Ankle Arthrodesis and Open Reduction and Internal Fixation Using Cellular Bone Allograft Augmentation

Moran

Sequeira

Cooper

et al. 2020

Foot & Ankle Specialist

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Background ViviGen is an allogeneic cellular bone matrix product containing lineage-committed bone cells, and can be used as an alternative to autograft bone or other augments to aid in arthrodesis or to enhance bony healing in open reduction and internal fixation (ORIF) procedures. Methods This study included 153 consecutive patients undergoing ankle, midfoot, or hindfoot arthrodesis or ORIF procedures from January 2017 to October 2018, in which an allogeneic cellular bone matrix product was used to aid in bony healing. Retrospective chart review identified patient demographic factors and medical comorbidities and evaluated clinical and radiographic data to determine fusion/union rate and complications. Results The overall fusion rate for the arthrodesis cohort was 97/113 (85.8%). The overall complication rate in this cohort was 22/113 (19.5%). Smokers had significantly lower rates of fusion compared with nonsmokers ( P = .01). The observed bony healing rate for the ORIF cohort was 19/22 (86.4%), with a complication rate of 3/22 (13.6%). Conclusion With satisfactory fusion rates and relatively few complications, our findings suggest that ViviGen is a safe and efficacious alternative to other forms of bone graft augmentation for fusion and ORIF procedures about the foot and ankle. Further study is needed to compare the efficacy of ViviGen with autograft bone and other augments. Levels of Evidence: Level IV: Case series

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Section: Discussionmentioning

confidence: 86%

A Retrospective Analysis of Outcomes From Foot and Ankle Arthrodesis and Open Reduction and Internal Fixation Using Cellular Bone Allograft Augmentation

Moran

Sequeira

Cooper

et al. 2020

Foot & Ankle Specialist

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“…Cellular bone allografts (CBAs) are another alternative that are theoretically more similar to autograft in that they are also presumed to be osteoinductive, osteoconductive, and osteogenic [11,12]. While most CBAs rely on viable cryopreserved mesenchymal stem cells for their osteogenic component, a more recent advanced CBA (V-CBA; marketed as ViviGen ® by LifeNet Health ® , Virginia Beach VA) is comprised of lineage-committed bone-forming cells, which may be more conducive to effect bone fusion [13][14][15].…”

Section: Introductionmentioning

confidence: 99%

A 24-month retrospective update: follow-up hospitalization charges and readmissions in US lumbar fusion surgeries using a cellular bone allograft (CBA) versus recombinant human bone morphogenetic protein-2 (rhBMP-2)

et al. 2021

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Background The objectives of this study were to build upon previously-reported 12-month findings by retrospectively comparing 24-month follow-up hospitalization charges and potentially-relevant readmissions in US lumbar fusion surgeries that employed either recombinant human bone morphogenetic protein-2 (rhBMP-2) or a cellular bone allograft comprised of viable lineage-committed bone cells (V-CBA) via a nationwide healthcare system database. Methods A total of 16,172 patients underwent lumbar fusion surgery using V-CBA or rhBMP-2 in the original study, of whom 3,792 patients (23.4%) were identified in the current study with all-cause readmissions during the 24-month follow-up period. Confounding baseline patient, procedure, and hospital characteristics found in the original study were used to adjust multivariate regression models comparing differences in 24-month follow-up hospitalization charges (in 2020 US dollars) and lengths of stay (LOS; in days) between the groups. Differences in potentially-relevant follow-up readmissions were also compared, and all analyses were repeated in the subset of patients who only received treatment at a single level of the spine. Results The adjusted cumulative mean 24-month follow-up hospitalization charges in the full cohort were significantly lower in the V-CBA group ($99,087) versus the rhBMP-2 group ($124,389; P < 0.0001), and this pattern remained in the single-level cohort (V-CBA = $104,906 vs rhBMP-2 = $125,311; P = 0.0006). There were no differences between groups in adjusted cumulative mean LOS in either cohort. Differences in the rates of follow-up readmissions aligned with baseline comorbidities originally reported for the initial procedure. Subsequent lumbar fusion rates were significantly lower for V-CBA patients in the full cohort (10.12% vs 12.00%; P = 0.0002) and similar between groups in the single-level cohort, in spite of V-CBA patients having significantly higher rates of baseline comorbidities that could negatively impact clinical outcomes, including bony fusion. Conclusions The results of this study suggest that use of V-CBA for lumbar fusion surgeries performed in the US is associated with substantially lower 24-month follow-up hospitalization charges versus rhBMP-2, with both exhibiting similar rates of subsequent lumbar fusion procedures and potentially-relevant readmissions.

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“…Most CBAs contain mesenchymal stem cells that have the potential to differentiate into bone cells, but may also differentiate into other non-bone-forming cells, such as adipocytes, tenocytes, and myocytes. Unlike other CBAs, ViviGen Formable cellular bone allograft (V-CBA) was developed to be similar to healthy autograft: it contains viable, osteogenic lineage-committed bone cells in an osteoconductive cortico-cancellous matrix along with demineralized bone with osteoinductive potential [7,8].…”

Section: Introductionmentioning

confidence: 99%

Clinical outcome and explant histology after using a cellular bone allograft in two-stage total hip arthroplasty

Shahrdar¹,

McLean

Gianulis

et al. 2020

J Orthop Surg Res

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Background Although use of cellular bone allografts (CBA) in orthopedic surgery has become increasingly common, little information is available regarding their short-term clinical performance. In these two case reports of two-stage hip arthroplasties, ViviGen Formable CBA (V-CBA) was used in stage one to fill voids left by previous metal implants. Methods The two patients had distinctly different health profiles, but each of them had previous metal implants due to a hip fracture. In the otherwise healthy 49-year-old male patient, the total hip arthroplasty (THA) was performed 7 weeks after nail removal and V-CBA backfill. In the 64-year-old female patient with Type 1 diabetes and severe osteoporosis, stage 2 was performed after 12 weeks. At the time of THA for each patient, bone containing some V-CBA was removed to accommodate the hip implant. The explants were histologically analyzed for bone matrix, mineralization, and neovascularization. Results Histological staining showed substantial new bone formation and neovascularization in both explants albeit at different levels of maturity. Conclusions Although limited, these results suggest that V-CBA may facilitate new bone formation in healthy as well as in metabolically challenged patients. Level of evidence V, case report

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Living Cryopreserved Bone Allograft as an Adjunct for Hindfoot Arthrodesis

Cited by 9 publications

References 30 publications

A Retrospective Analysis of Outcomes From Foot and Ankle Arthrodesis and Open Reduction and Internal Fixation Using Cellular Bone Allograft Augmentation

A Retrospective Analysis of Outcomes From Foot and Ankle Arthrodesis and Open Reduction and Internal Fixation Using Cellular Bone Allograft Augmentation

A 24-month retrospective update: follow-up hospitalization charges and readmissions in US lumbar fusion surgeries using a cellular bone allograft (CBA) versus recombinant human bone morphogenetic protein-2 (rhBMP-2)

Clinical outcome and explant histology after using a cellular bone allograft in two-stage total hip arthroplasty

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