scholarly journals A comparison of radiographic and clinical outcomes of anterior lumbar interbody fusion performed with either a cellular bone allograft containing multipotent adult progenitor cells or recombinant human bone morphogenetic protein-2

Author(s):  
Daniel Dongwhan Lee ◽  
John Yongmin Kim
2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Bradley Wetzell ◽  
Julie B. McLean ◽  
Mark A. Moore ◽  
Venkateswarlu Kondragunta ◽  
Kimberly Dorsch

Abstract Background The objective of this study was to retrospectively compare initial procedure and 12-month follow-up hospitalization charges and resource utilization (lengths of stay; LOS) for lumbar fusion surgeries using 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 large US healthcare system database. Potentially relevant re-admissions during the follow-up period were also assessed. Methods A total of 16,172 patients underwent lumbar fusion surgery using V-CBA or rhBMP-2, of whom 3503 (21.66%) patients had follow-up re-admission data. Initial patient, procedure, and hospital characteristics were assessed to determine confounding factors. Multivariate regression modeling compared differences in hospitalization charges (in 2018 US dollars) and LOS (in days) between the groups, as well as incidences of potentially relevant re-admissions during the 12-month follow-up period. Results The adjusted mean initial procedure and 12-month follow-up hospital charges were significantly lower in the V-CBA group versus the rhBMP-2 group ($109,061 and $108,315 versus $160,191 and $130,406, respectively; P < 0.0001 for both comparisons). This disparity remained in an ad hoc comparison of charges for initial single-level treatments only (V-CBA = $103,064, rhBMP-2 = $149,620; P < 0.0001). The adjusted mean initial LOS were significantly lower in the V-CBA group (3.77 days) versus the rhBMP-2 group (3.88 days; P < 0.0001), but significantly higher for the cumulative follow-up hospitalizations in the 12-month follow-up period (7.87 versus 7.46 days, respectively; P < 0.0001). Differences in rates of follow-up re-admissions aligned with comorbidities at the initial procedure. Subsequent lumbar fusion rates were comparable, but significantly lower for V-CBA patients who had undergone single-level treatments only, in spite of V-CBA patients having significantly higher rates of initial comorbidities that could negatively impact clinical outcomes. Conclusions The results of this study indicate that use of V-CBA for lumbar fusion surgeries performed in the US may result in substantially lower overall hospitalization charges versus rhBMP-2, with both exhibiting similar rates of 12-month re-admissions and subsequent lumbar fusion procedures.


2020 ◽  
Author(s):  
Bradley Wetzell ◽  
Julie B McLean ◽  
Mark A Moore ◽  
Venkateswarlu Kondragunta ◽  
Kimberly Dorsch

Abstract BackgroundThe objective of this study was to retrospectively compare initial procedure and 12-month follow-up hospitalization charges and resource utilization (lengths of stay; LOS) for lumbar fusion surgeries using 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 large US healthcare system database. Potentially-relevant re-admissions during the follow-up period were also assessed.MethodsA total of 16,172 patients underwent lumbar fusion surgery using V-CBA or rhBMP-2, of whom 3,503 (21.66%) patients had follow-up re‑admission data. Initial patient, procedure, and hospital characteristics were assessed to determine confounding factors. Multivariate regression modeling compared differences in hospitalization charges (in 2018 US dollars) and LOS (in days) between the groups, as well as incidences of potentially-relevant readmissions during the 12‑month follow-up‑ period.ResultsThe adjusted mean initial procedure and 12-month follow-up‑ hospital charges were significantly lower in the V-CBA group versus the rhBMP-2 group ($109,061 and $108,315 versus $160,191 and $130,406, respectively; P<0.0001 for both comparisons). This disparity remained in an ad hoc comparison of charges for initial single-level treatments only (V-CBA = $103,064, rhBMP-2 = $149,620; P<0.0001).The adjusted mean initial LOS were significantly lower in the V-CBA group (3.77 days) versus the rhBMP-2 group (3.88 days; P<0.0001), but significantly higher for the cumulative follow-up hospitalizations in the 12‑month follow-up period (7.87 versus 7.46 days, respectively; P<0.0001). Differences in rates of follow-up re‑admissions aligned with comorbidities at the initial procedure. Subsequent lumbar fusion rates were comparable, but significantly lower for V-CBA patients who had undergone single-level treatments only, in spite of V-CBA‑ patients having significantly higher rates of initial comorbidities that could negatively impact clinical outcomes.ConclusionsThe results of this study indicate that use of V-CBA for lumbar fusion surgeries performed in the US may result in substantially lower overall hospitalization charges versus rhBMP-2, with both exhibiting similar rates of 12-month re-admissions and subsequent lumbar fusion procedures.


2020 ◽  
Author(s):  
Bradley Wetzell ◽  
Julie B McLean ◽  
Mark A Moore ◽  
Venkateswarlu Kondragunta ◽  
Kimberly Dorsch

Abstract BackgroundThis retrospective study of a large US healthcare system database compared initial procedure and 12-month follow-up hospitalization charges and resource utilization (lengths of stay; LOS) for lumbar fusion surgeries using either recombinant human bone morphogenetic protein-2 (rhBMP‑2) or a cellular bone allograft comprised of viable lineage-committed bone cells (V‑CBA). Potentially-relevant re-admissions during the follow-up period were also assessed.MethodsA total of 16,172 patients underwent lumbar fusion surgery using V-CBA or rhBMP-2, of whom 3,503 (21.66%) patients had follow-up re‑admission data. Initial patient, procedure, and hospital characteristics were assessed to determine confounding factors. Multivariate regression modeling compared differences in hospitalization charges (in 2018 US dollars) and LOS (in days) between the groups, as well as incidences of potentially-relevant re‑admissions during the 12‑month follow‑up period.ResultsThe adjusted mean initial procedure and 12-month follow‑up hospital charges were significantly lower in the V-CBA group versus the rhBMP‑2 group ($109,061 and $108,315 versus $160,191 and $130,406, respectively; P<0.0001 for both comparisons). This disparity remained in an ad hoc comparison of charges for initial single-level treatments only (V‑CBA = $103,064, rhBMP-2 = $149,620; P<0.0001).The adjusted mean initial LOS were significantly lower in the V‑CBA group (3.77 days) versus the rhBMP-2 group (3.88 days; P<0.0001), but significantly higher for the cumulative follow-up hospitalizations in the 12‑month follow-up period (7.87 versus 7.46 days, respectively; P<0.0001). Differences in rates of follow-up re‑admissions aligned with comorbidities at the initial procedure. Subsequent lumbar fusion rates were comparable, but significantly lower for V-CBA patients who had undergone single-level treatments only, in spite of V‑CBA patients having significantly higher rates of initial comorbidities that could negatively impact clinical outcomes.ConclusionsThe results of this study indicate that use of V-CBA for lumbar fusion surgeries performed in the US may result in substantially lower overall hospitalization charges versus rhBMP-2, with both exhibiting similar rates of 12-month re-admissions and subsequent lumbar fusion procedures.


2004 ◽  
Vol 16 (3) ◽  
pp. 1-4 ◽  
Author(s):  
Todd H. Lanman ◽  
Thomas J. Hopkins

Object To evaluate the effectiveness of recombinant human bone morphogenetic protein–2 (rhBMP-2) combined with a bioresorbable implant, the authors conducted a prospective study of 43 patients with degenerative lumbar disc disease who underwent transforaminal lumbar interbody fusion. Methods The authors used Infuse bone graft, which consisted of rhBMP-2 applied to an absorbable collagen sponge and contained within a HYDROSORB Telamon bioresorbable implant to perform the fusion. Multilevel fusions were performed in 30% of the 43 patients, for a total of 57 levels. At 6 months postoperatively, x-ray films and computerized tomography (CT) scans demonstrated solid fusion in 98% of 41 patients. Improvement from the baseline Oswestry Disability Rating was demonstrated at 6 months postoperatively in 68% of the patients, based on the Oswestry Disability Questionnaire. At 12 months all 11 patients in whom CT scans were obtained showed complete bridging of bone; there were no device-related complications. Conclusions Results in this series provide evidence of the feasibility of using HYDROSORB Telamon biore-sorbable spacers in combination with Infuse bone graft for lumbar spine fusion.


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