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)

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.

Immediate Mandibular Reconstruction Using a Cellular Bone Allograft Following Tumor Resection in a Pediatric Patient

Reconstruction of large segmental mandibular defects presents a challenge for oral and maxillofacial surgeons, particularly in the skeletally immature pediatric patient. Autogenous bone graft is historically preferred; however, harvest of autograft requires a second surgical site, risking donor-site complications as well as the potential for long-term complications in the growing child. Here, we present the first known report of a pediatric patient who underwent immediate mandibular reconstruction of a 6.5-cm long segmental defect using a cellular bone allograft (VF-CBA) combined with custom-fabricated guides and plates following tumor resection. The use of VF-CBA, along with the custom guides and plates, eliminated the need for autograft harvest in a child, enabled an entirely intraoral approach, avoiding the creation of a cutaneous scar, and reduced the total operative time, resulting in a fast recovery and improved patient satisfaction. By 7 months postoperative, the patient’s mandible was fully healed with solid osseous consolidation. These results support VF-CBA combined with custom intraoral guides and plates as an effective treatment option for reconstruction of large segmental mandibular defects in a pediatric patient.

Lumbar spine fusion outcomes using a cellular bone allograft with lineage-committed bone-forming cells in 96 patients

Background Instrumented posterior lumbar fusion (IPLF) with and without transforaminal interbody fusion (TLIF) is a common treatment for low back pain when conservative interventions have failed. Certain patient comorbidities and lifestyle risk factors, such as obesity and smoking, are known to negatively affect these procedures. An advanced cellular bone allograft (CBA) with viable osteogenic cells (V-CBA) has demonstrated high fusion rates, but the rates for patients with severe and/or multiple comorbidities remain understudied. The purpose of this study was to assess fusion outcomes in patients undergoing IPLF/TLIF using V-CBA with baseline comorbidities and lifestyle risk factors known to negatively affect bone fusion. Methods This was a retrospective study of de-identified data from consecutive patients at an academic medical center who underwent IPLF procedures with or without TLIF, and with V-CBA. Baseline patient and procedure characteristics were assessed. Radiological outcomes included fusion rates per the Lenke scale. Patient-reported clinical outcomes were evaluated via the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) for back and leg pain. Operating room (OR) times and intraoperative blood loss rates were also assessed. Results Data from 96 patients were assessed with a total of 222 levels treated overall (mean: 2.3 levels) and a median follow-up time of 16 months (range: 6 to 45 months). Successful fusion (Lenke A or B) was reported for 88 of 96 patients (91.7%) overall, including in all IPLF-only patients. Of 22 patients with diabetes in the IPLF+TLIF group, fusion was reported in 20 patients (90.9%). In IPLF+TLIF patients currently using tobacco (n = 19), fusion was reported in 16 patients (84.3%), while in those with a history of tobacco use (n = 53), fusion was observed in 48 patients (90.6%). Successful fusion was reported in all 6 patients overall with previous pseudarthrosis at the same level. Mean postoperative ODI and VAS scores were significantly reduced versus preoperative ratings. Conclusion The results of this study suggest that V-CBA consistently yields successful fusion and significant decreases in patient-reported ODI and VAS, despite patient comorbidities and lifestyle risk factors that are known to negatively affect such bony healing.

Treatment of Mandibular Non-union Using Patient Specific Crib Cage Plates and Cellular Bone Allograft: A Case Report

A gunshot wound to the mandible frequently creates a comminuted fracture that can be debilitating for the patient and challenging for the surgeon. In some instances, immediate open reduction and rigid fixation is not possible, and closed reduction with intermaxillary fixation is employed. This may lead to non-union or mal-union of the segments. This case report describes the management of mal-union of bilateral comminuted mandibular angle fractures secondary to a gunshot wound injury. The mandibular fractures were repaired using virtually planned patient specific reconstruction plates that included a specially designed crib cage to contain a bone graft. A cellular bone allograft—Vivigen (DePuy Synthes, Warsaw, IN)—was chosen as the bone grafting material. The patient was followed up for 7 months with normal functional status and mouth opening and without pain or signs of infection. This report demonstrates that using a virtually planned crib cage plate with cellular bone allograft can optimize surgical repair and bony healing of comminuted mandible fractures.

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)

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.

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)

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.

Repair of a Comminuted Talar Neck Fracture using a Cellular Bone Allograft combined with a Textured Allograft Wedge

Category: Trauma; Ankle Introduction/Purpose: Talar neck fractures are uncommon and are characterized by displacement, comminution, and soft tissue injury. Treatment of talar neck fractures while avoiding complications, such as osteonecrosis and long-term morbidity, presents a unique challenge to surgeons. One option for treating talar neck fractures is cellular bone allograft containing viable lineage- committed bone cells (V-CBA), which provides the osteoconductive, osteoinductive, and osteogenic properties needed for bone formation. Additionally, a structural textured allograft (STA) wedge designed to resist migration and sustain compressive force can also be used in repairing talar neck fractures. This case study describes the successful repair of a comminuted talar neck fracture using V-CBA combined with an STA wedge. Methods: A 46-year-old male patient sustained a talar neck fracture following a fall from a 12-foot ladder. Radiographic and computed tomography (CT) imaging revealed significant comminution, consequent varus angulation, and a large bony void, as well as dislocation of the posterior subtalar joint. The patient was otherwise healthy with no comorbidities. Open reduction internal fixation was performed laterally to reduce the posterior subtalar dislocation. Medially, a 6.5mm STA wedge was used to correct the varus deformity and 1cc of V-CBA was used to fill the void. Results: At 6 months, the talar neck fracture had healed with solid osseous consolidation evident on radiographic images. Conclusion: These results demonstrate that an STA wedge, with a textured design that resists migration, used in combination with a V-CBA successfully repaired a comminuted talar neck fracture.

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)

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.