High Lumbar Spinal Fusion Rates Using Cellular Bone Allograft Irrespective of Surgical Approach.

BACKGROUND: Mounting evidence demonstrates a promising safety and efficacy profile for spinal fusion procedures using cellular bone allograft (CBA). However, limited data exists on fusion outcomes stratified by surgical approach. The current study investigates the effectiveness of CBA in lumbar spinal fusion by surgical approach (ie, anterior, lateral, and posterior approaches). METHODS: Patients undergoing lumbar spinal fusion with CBA (Trinity Elite) were enrolled into a prospective, multi-center, open-label clinical study (NCT02969616). Fusion status was assessed by an independent review of dynamic radiographs and computed tomography images. Clinical outcome measures included quality of life (QoL; EQ5D), disability (Oswestry Disability Index [ODI]), and pain (visual analog scale [VAS]) for back pain and leg pain). Patient data extending to 24 months were analyzed in a post-hoc analysis. RESULTS: A total of 252 patients underwent interbody fusion (159 women; 93 men). Patients had a mean age of 58.3 years (SD 12.5), height of 168.3 cm (SD 10.2), and weight of 87.3 kg (SD 20.0) with a body mass index of 30.8 kg/m2 (SD 6.5). At 12 months, the overall fusion success rate for bridging bone was 98.5%; fusion success was 98.1%, 100.0%, and 97.9% for anterior, lateral, and posterior approaches, respectively. At 24 months, the overall fusion success rate for bridging bone was 98.9%; fusion success was 97.9%, 100.0%, and 98.8% for anterior, lateral, and posterior approaches, respectively. The surgical approach did not significantly impact fusion success. A significant (P < 0.0001) improvement in QoL, pain, and disability scores was also observed. Significant differences in the ODI, VAS, and EQ5D were observed between the treatment groups (P < 0.05). CONCLUSIONS: CBA represents an attractive alternative to autograft alone, reporting a high rate of successful fusion and clinical outcomes across various surgical approaches. CLINICAL RELEVANCE: The use of CBA for spinal fusion procedures, regardless of surgical approach, provides high rates of fusion with a favorable safety profile and improved patient outcomes. TRIAL REGISTRATION: NCT02969616.

Impact of surgical risk factors for non-union on lumbar spinal fusion outcomes using cellular bone allograft at 24-months follow-up.

BACKGROUND: The current report investigates fusion rates and patient-reported outcomes following lumbar spinal surgery using cellular bone allograft (CBA) in patients with risk factors for non-union. METHODS: A prospective, open label study was conducted in subjects undergoing lumbar spinal fusion with CBA (NCT02969616) to assess fusion success rates and patient-reported outcomes in subjects with risk factors for non-union. Subjects were categorized into low-risk (≤ 1 risk factors) and high-risk (> 1 risk factors) groups. Radiographic fusion status was evaluated by an independent review of dynamic radiographs and CT scans. Patient-reported outcome measures included quality of life (EQ-5D), Oswestry Disability Index (ODI) and Visual Analog Scales (VAS) for back and leg pain. Adverse event reporting was conducted throughout 24-months of follow-up. RESULTS: A total of 274 subjects were enrolled: 140 subjects (51.1%) were categorized into the high-risk group (> 1 risk factor) and 134 subjects (48.9%) into the low-risk group (≤ 1 risk factors). The overall mean age at screening was 58.8 years (SD 12.5) with a higher distribution of females (63.1%) than males (36.9%). No statistical difference in fusion rates were observed between the low-risk (90.0%) and high-risk (93.9%) groups (p > 0.05). A statistically significant improvement in patient-reported outcomes (EQ-5D, ODI and VAS) was observed at all time points (p < 0.05) in both low and high-risk groups. The low-risk group showed enhanced improvement at multiple timepoints in EQ-5D, ODI, VAS-Back pain and VAS-Leg pain scores compared to the high-risk group (p < 0.05). The number of AEs were similar among risk groups. CONCLUSIONS: This study demonstrates high fusion rates following lumbar spinal surgery using CBA, regardless of associated risk factors. Patient reported outcomes and fusion rates were not adversely affected by risk factor profiles. TRIAL REGISTRATION: NCT02969616 (21/11/2016).

Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusion.

BACKGROUND: Autologous bone grafts are the gold standard for spinal fusion; however, harvesting autologous bone can result in donor site infection, hematomas, increased operative time, and prolonged pain. Cellular bone allografts (CBAs) are a viable alternative that avoids the need for bone harvesting and may increase fusion success alone or when used as an adjunct material. The present study examined the efficacy and safety of CBA when used as an adjunct graft material to lumbar arthrodesis. METHODS: A prospective, single-arm, multicenter clinical trial (NCT02969616) was conducted in adult subjects (> 18 years of age) undergoing lumbar spinal fusion with CBA graft (CBA used as primary (≥ 50% by volume), with augmentation up to 50%). Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. Clinical outcomes were assessed with the Oswestry Disability Index (ODI), and Visual Analog Scales (VAS) score for back and leg pain. Adverse events were assessed through the 24-month follow-up period. The presented data represents an analysis of available subjects (n = 86) who completed 24 months of postoperative follow-up at the time the data was locked for analysis. RESULTS: Postoperative 24-month fusion success was achieved in 95.3% of subjects (n = 82/86) undergoing lumbar spinal surgery. Clinical outcomes showed statistically significant improvements in ODI (46.3% improvement), VAS-Back pain (75.5% improvement), and VAS-Leg pain (85.5% improvement) (p < 0.01) scores at Month 24. No subject characteristics or surgical factors were associated with pseudoarthrosis. A favorable safety profile with a limited number of adverse events was observed. CONCLUSIONS: The use of CBA as an adjunct graft material showed high rates of successful lumbar arthrodesis and significant improvements in pain and disability scores. CBA provides an alternative to autograft with comparable fusion success rates and clinical benefits. TRIAL REGISTRATION: NCT02969616.

Twelve-Month Results from a Prospective Clinical Study Evaluating the Efficacy and Safety of Cellular Bone Allograft in Subjects Undergoing Lumbar Spinal Fusion.

BACKGROUND: While autologous bone grafts remain the gold standard for spinal fusion procedures, harvesting autologous bone is associated with significant complications, including donor site infection, hematomas, increased operative time, and prolonged pain. Cellular bone allograft (CBA) presents an alternative to autologous bone harvesting, with a favorable efficacy and safety profile. The current study further investigates CBA as an adjunct to lumbar spinal fusion procedures. METHODS: A prospective, multicenter, open-label clinical study was conducted in subjects undergoing lumbar spinal fusion with CBA (NCT02969616). Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. Clinical outcome measures included the Oswestry Disability Index (ODI) and visual analogue scale (VAS) for back and leg pain. Adverse-event reporting was conducted throughout 12 months of follow-up. Available subject data at 12 months were analyzed. RESULTS: A total of 274 subjects were enrolled into the study, with available data from 201 subjects (73.3%) who completed 12 months of postoperative radiographic and clinical evaluation at the time of analysis. Subjects had a mean age of 60.2 ± 11.5 years. A higher number of women (n = 124, 61.7%) than men (n = 77, 38.3%) were enrolled, with a collective mean BMI of 30.6 + 6.5 kg/m2 (range 18.0-51.4). At month 12, successful fusion was achieved in 90.5% of subjects. A significant (p < 0.001) improvement in ODI, VAS-back, and VAS-leg clinical outcomes was also observed compared to baseline scores. One adverse event related to CBA (postoperative radiculopathy) was reported, with surgical exploration demonstrating interbody extrusion of graft material. This subject reported successful fusion at month 12. CONCLUSIONS: CBA represents a viable substitute for harvesting of autograft alone with a high rate of successful fusion and significant improvements in subject-reported outcomes, such as pain and disability. Positive benefit was observed in subjects reporting single and multiple risk factors for pseudoarthrosis.

Protective effects of ethanolic extract from the red algae Amansia multifida on experimental inflammation, nociception and seizure experimental models / Efeito protetor do extrato etanólico da alga marinha vermelha Amansia multifida em modelos experimentais de inflamação, nocicepção e convulsão

This study aimed to investigate the EEAm effect in mice models of nociception, inflammation and in behavioral tests evaluating the central nervous system. EEAm had inhibitory effects in the following tests: acetic acid-induced writhing (78%); formalin (62% - inflammatory phase); open field (46%). EEAm increased the nociceptive latency (56%) in tail flick test and increased the death-latency by 36% in the pentylenetetrazole-induced seizure model. Moreover, EEAm inhibited paw edema (82%) and peritonitis (45%) induced by carrageenan. In conclusion, EEAm presents antinociceptive, anti-inflammatory and anticonvulsant effects involving peripheral and central-acting mechanisms in mice.

Neste estudo objetivou-se investigar o efeito do EEAm em modelos de nocicepção e inflamação, e em testes comportamentais que avaliam o sistema nervoso central em camundongos. EEAm exibiu efeitos inibitórios nos testes comportamentais de contorções abdominais induzidas por ácido acético (78%); formalina (62% - fase inflamatória) e campo aberto (46%). EEAm aumentou a latência de nocicepção no teste de retirada da cauda (56%) e a latência de morte 36% no modelo de convulsões induzidas por pentilenetetrazol. Além disso, EEAm inibiu o edema de pata (82%) e a peritonite (45%) induzidos por carragenana. Como conclusão, EEAm apresenta efeitos antinociceptivo, anti-inflamatório e anticonvulsivante em camundongos por mecanismos periféricos e centrais.

Relationship of donor variables and graft dimension on biomechanical performance of femoral ring allograft.

Structural femoral ring allograft is commonly used in interbody spinal arthrodesis. Fractures of implanted femoral ring allograft have been reported. Data to guide donor screening and tissue processing by allograft tissue banks for factors that affect graft strength are incomplete. Fresh frozen human femora from 34 cadaveric donors were sectioned into ten 20-mm thick specimens. Bone mineral density (BMD), donor age, and graft dimensions were recorded for each specimen. Three hundred twenty-seven specimens were tested in quasi-static axial compression. Linear regression models compared load to failure with BMD, sex-specific donor age, minimum/maximum cortical wall thickness, and minimum/maximum outer ring diameter. Correlations between minimum and maximum cortical wall thickness and load to failure were significant (r = 0.73, p < 0.001 and r = 0.74, p < 0.001, respectively). BMD showed a weaker negative correlation with load to failure (r = -0.11, p = 0.05). Correlations between load to failure and minimum and maximum outer ring diameter and age (r = 0.06, p = 0.31) were not significant. We found that the minimum and maximum cortical wall thicknesses of femoral ring allograft are strongly correlated with the axial compressive load to failure of the graft. Other tested parameters did not prove to be effective predictors of resistance to axial loading.