Abstract:Osteoconductive BGEs combined with local spine autograft and/or bone marrow aspirate have comparable fusion rates, similar functional outcomes, lower complication rates, and a lower risk of donor site pain than ICBG. Caution should be taken in interpreting these findings, given the low quality of the studies and the heterogeneity in the results. Randomized controlled studies using blinded assessments are required to help elucidate more conclusive evidence.
“…In comparison to previous studies, which show either an inferiority of calcium phosphates compared to autograft or equivalence evidenced through weaker endpoints, we demonstrate equivalent performance of AG, BCP granules and BCP putty by an array of strong assessment methods. In clinical literature, we can find conflicting evidence about the efficacy of calcium phosphate materials as bone graft materials for spine fusion . Physicochemical properties of biomaterials are rarely discussed in clinical literature and it is often overlooked that these properties strongly influence the performance of calcium phosphate bone graft materials.…”
As spinal fusions require large volumes of bone graft, different bone graft substitutes are being investigated as alternatives. A subclass of calcium phosphate materials with submicron surface topography has been shown to be a highly effective bone graft substitute. In this work, a commercially available biphasic calcium phosphate (BCP) with submicron surface topography (MagnetOs; Kuros Biosciences BV) was evaluated in an
Ovine
model of instrumented posterolateral fusion. The material was implanted stand‐alone, either as granules (BCP
granules
) or as granules embedded within a fast‐resorbing polymeric carrier (BCP
putty
) and compared to autograft bone (AG). Twenty‐five adult, female Merino sheep underwent posterolateral fusion at L2‐3 and L4‐5 levels with instrumentation. After 6, 12, and 26 weeks, outcomes were evaluated by manual palpation, range of motion (ROM) testing, micro‐computed tomography, histology and histomorphometry. Fusion assessment by manual palpation 12 weeks after implantation revealed 100% fusion rates in all treatment groups. The three treatment groups showed a significant decrease in lateral bending at the fusion levels at 12 weeks (
P
< 0.05) and 26 weeks (
P
< 0.001) compared to the 6 week time‐point. Flexion‐extension and axial rotation were also reduced over time, but statistical significance was only reached in flexion‐extension for AG and BCP
putty
between the 6 and 26 week time‐points (
P
< 0.05). No significant differences in ROM were observed between the treatment groups at any of the time‐points investigated. Histological assessment at 12 weeks showed fusion rates of 75%, 92%, and 83% for AG, BCP
granules
and BCP
putty
, respectively. The fusion rates were further increased 26 weeks postimplantation. Similar trends of bone growth were observed by histomorphometry. The fusion mass consisted of at least 55% bone for all treatment groups 26 weeks after implantation. These results suggest that this BCP with submicron surface topography, in granules or putty form, is a promising alternative to autograft for spinal fusion.
“…In comparison to previous studies, which show either an inferiority of calcium phosphates compared to autograft or equivalence evidenced through weaker endpoints, we demonstrate equivalent performance of AG, BCP granules and BCP putty by an array of strong assessment methods. In clinical literature, we can find conflicting evidence about the efficacy of calcium phosphate materials as bone graft materials for spine fusion . Physicochemical properties of biomaterials are rarely discussed in clinical literature and it is often overlooked that these properties strongly influence the performance of calcium phosphate bone graft materials.…”
As spinal fusions require large volumes of bone graft, different bone graft substitutes are being investigated as alternatives. A subclass of calcium phosphate materials with submicron surface topography has been shown to be a highly effective bone graft substitute. In this work, a commercially available biphasic calcium phosphate (BCP) with submicron surface topography (MagnetOs; Kuros Biosciences BV) was evaluated in an
Ovine
model of instrumented posterolateral fusion. The material was implanted stand‐alone, either as granules (BCP
granules
) or as granules embedded within a fast‐resorbing polymeric carrier (BCP
putty
) and compared to autograft bone (AG). Twenty‐five adult, female Merino sheep underwent posterolateral fusion at L2‐3 and L4‐5 levels with instrumentation. After 6, 12, and 26 weeks, outcomes were evaluated by manual palpation, range of motion (ROM) testing, micro‐computed tomography, histology and histomorphometry. Fusion assessment by manual palpation 12 weeks after implantation revealed 100% fusion rates in all treatment groups. The three treatment groups showed a significant decrease in lateral bending at the fusion levels at 12 weeks (
P
< 0.05) and 26 weeks (
P
< 0.001) compared to the 6 week time‐point. Flexion‐extension and axial rotation were also reduced over time, but statistical significance was only reached in flexion‐extension for AG and BCP
putty
between the 6 and 26 week time‐points (
P
< 0.05). No significant differences in ROM were observed between the treatment groups at any of the time‐points investigated. Histological assessment at 12 weeks showed fusion rates of 75%, 92%, and 83% for AG, BCP
granules
and BCP
putty
, respectively. The fusion rates were further increased 26 weeks postimplantation. Similar trends of bone growth were observed by histomorphometry. The fusion mass consisted of at least 55% bone for all treatment groups 26 weeks after implantation. These results suggest that this BCP with submicron surface topography, in granules or putty form, is a promising alternative to autograft for spinal fusion.
“…Fusion rates above 85% at 2 to 3 years post-procedure have been demonstrated for both local and iliac crest bone grafts [12,32]. Synthetic BGEs have been associated with similar rates of fusion success, with one recent systematic review [7] reporting an 86.4% fusion rate when ceramic materials were utilized as the BGE, while another systematic review [13] found pooled fusion rates ranged from 75% with calcium sulphate to 98.2% with a combination of hydroxyapatite and tricalcium phosphate. The current study included supplemental posterolateral fusion for which greater quantities of bone graft are required.…”
Section: Discussionmentioning
confidence: 99%
“…While these products provide a suitable scaffolding upon which to build new bone, they are inherently unable to stimulate bone growth without the patient's own bone or marrow to augment the process. Alternate options such as tricalcium phosphate, calcium sulfate and hydroxyapatite, while possessing osteoconductive properties, are associated with equivocal results regarding fusion rates [13]. To address the shortcomings of the currently available technology, a fully-resorbable hybrid biosynthetic autograft extender for use in spinal fusion was developed (InQu ® , ISTO Technologies, Inc., St. Louis, MO).…”
Autologous iliac crest bone graft is the preferred option for spinal fusion, but the morbidity associated with bone harvest and the need for graft augmentation in more demanding cases necessitates combining local bone with bone substitutes. The purpose of this study was to document the clinical effectiveness and safety of a novel hybrid biosynthetic scaffold material consisting of poly(D,L-lactide-co-glycolide) (PLGA, 75:25) combined by lyophilization with unmodified high molecular weight hyaluronic acid (10-12% wt:wt) as an extender for a broad range of spinal fusion procedures. We retrospectively evaluated all patients undergoing single-and multi-level posterior lumbar interbody fusion at an academic medical center over a 3-year period. A total of 108 patients underwent 109 procedures (245 individual vertebral levels). Patient-related outcomes included pain measured on a Visual Analog Scale. Radiographic outcomes were assessed at 6 weeks, 3-6 months, and 1 year postoperatively. Radiographic fusion or progression of fusion was documented in 221 of 236 index levels (93.6%) at a mean (±SD) time to fusion of 10.2+4.1 months. Single and multilevel fusions were not associated with significantly different success rates. Mean pain scores (+SD) for all patients improved from 6.8+2.5 at baseline to 3.6+2.9 at approximately 12 months. Improvements in VAS were greatest in patients undergoing one-or two-level fusion, with patients undergoing multi-level fusion demonstrating lesser but still statistically significant improvements. Overall, stable fusion was observed in 64.8% of vertebral levels; partial fusion was demonstrated in 28.8% of vertebral levels. Only 15 of 236 levels (6.4%) were non-fused at final follow-up.
“…Autogenous iliac crest bone graft has long been considered the “gold standard” used in spinal fusion procedures because its characteristics, such as osteogenesis, osteoinduction, and osteoconduction, are ideal for promoting fusion from a biological perspective [3]. But a series of complications accompanied by autogeneous bone grafting are inevitable.…”
Bone morphogenetic protein-2 (BMP-2) is a potent osteoinductive cytokine that plays a critical role in bone regeneration and repair. However, its distribution and side effects are major barriers to its success as therapeutic treatment. The improvement of therapy using collagen delivery matrices has been reported. To investigate a delivery system on postero-lateral spinal fusion, both engineered human BMP-2 with a collagen binding domain (CBD-BMP-2) and collagen scaffolds were developed and their combination was implanted into Sprague-Dawley (SD) rats to study Lumbar 4–5 (L4–L5) posterolateral spine fusion. We divided SD rats into three groups, the sham group (G1, n = 20), the collagen scaffold-treated group (G2, n = 20) and the BMP-2-loaded collagen scaffolds group (G3, n = 20). 16 weeks after surgery, the spines of the rats were evaluated by X-radiographs, high-resolution micro-computed tomography (micro-CT), manual palpation and hematoxylin and eosin (H&E) staining. The results showed that spine L4–L5 fusions occurred in G2(40%) and G3(100%) group, while results from the sham group were inconsistent. Moreover, G3 had better results than G2, including higher fusion efficiency (X score, G2 = 2.4±0.163, G3 = 3.0±0, p<0.05), higher bone mineral density (BMD, G2: 0.3337±0.0025g/cm3, G3: 0.4353±0.0234g/cm3. p<0.05) and more bone trabecular formation. The results demonstrated that with site-specific collagen binding domain, a dose of BMP-2 as low as 0.02mg CBD-BMP-2/cm3 collagen scaffold could enhance the posterolateral intertransverse process fusion in rats. It suggested that combination delivery could be an alternative in spine fusion with dramatically decreased side effects caused by high dose of BMP-2.
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