Instrumented Posterolateral Spinal Fusion Research Articles

Efficacy of Biphasic Calcium Phosphate Ceramic With a Needle-Shaped Surface Topography Versus Autograft in Instrumented Posterolateral Spinal Fusion.

A multicenter randomized controlled noninferiority trial with intrapatient comparisons. The aim of this study was to determine noninferiority of a slowly resorbable biphasic calcium phosphate with submicron microporosity (BCP<μm, MagnetOs Granules) as an alternative for autograft in instrumented posterolateral fusion (PLF). Successful spinal fusion with a solid bone bridge between the vertebrae is traditionally achieved by grafting with autologous iliac bone. However, the disadvantages of autografts and unsatisfactory fusion rates have prompted the exploration of alternatives, including ceramics. Nevertheless, clinical evidence for the standalone use of these materials is limited. Adults indicated for instrumented PLF (1 to 6 levels) were enrolled at 5 participating centers. After bilateral instrumentation and fusion-bed preparation, the randomized allocation side (left or right) was disclosed. Per segment 10 cc of BCP<μm granules (1 to 2mm) were placed in the posterolateral gutter on one side and 10 cc autograft on the contralateral side. Fusion was systematically scored on 1-year follow-up CT scans. The study was powered to detect >15% inferiority with binomial paired comparisons of the fusion performance score per treatment side. Of the 100 patients (57 ± 12.9 y, 62% female), 91 subjects and 128 segments were analyzed. The overall posterolateral fusion rate per segment (left and/or right) was 83%. For the BCP<μm side only the fusion rate was 79% versus 47% for the autograft side (difference of 32 percentage points, 95% CI, 23-41). Analysis of the primary outcome confirmed the noninferiority of BCP<μm with an absolute difference in paired proportions of 39.6% (95% CI, 26.8-51.2; p < 0.001). This clinical trial demonstrates noninferiority and indicates superiority of MagnetOs Granules as a standalone ceramic when compared to autograft for posterolateral spinal fusion. These results challange the belief that autologous bone is the most optimal graft material.

RESULTS OF BIPHASIC CALCIUM PHOSPHATE BONE GRAFT WITH SUBMICRON-SIZED NEEDLE-SHAPED SURFACE TOPOGRAPHY AS STANDALONE ALTERNATIVE TO AUTOGRAFT ARE FAVOURABLE IN A PROSPECTIVE, MULTICENTRE, RANDOMIZED, INTRA-PATIENT CONTROLLED TRIAL

Pseudoarthrosis after spinal fusion is an important complication leading to revision spine surgeries. Iliac Crest Bone Graft is considered the gold standard, but with limited availability and associated co-morbidities, spine surgeons often utilize alternative bone grafts.Determine the non-inferiority of a novel submicron-sized needle-shaped surface biphasic calcium phosphate (BCP&lt;µm) as compared to autograft in instrumented posterolateral spinal fusion.Adult patients indicated for instrumented posterolateral spinal fusion of one to six levels from T10-S2 were enrolled at five participating centers. After instrumentation and preparation of the bone bed, the randomized allocation side of the graft type was disclosed. One side was grafted with 10cc of autograft per level containing a minimum of 50% iliac crest bone. The other side was grafted with 10cc of BCP&lt;µm granules standalone (without autograft or bone marrow aspirate). In total, 71 levels were treated. Prospective follow-up included adverse events, Oswestry Disability Index (ODI), and a fine-cut Computerized Tomography (CT) at one year. Fusion was systematically scored as fused or not fused per level per side by two spine surgeons blinded for the procedure.The first fifty patients enrolled are included in this analysis (mean age: 57 years; 60% female and 40% male). The diagnoses included deformity (56%), structural instability (28%), and instability from decompression (20%). The fusion rate determined by CT for BCP&lt;μm was 76.1%, which compared favorably to the autograft fusion rate of 43.7%. Statistical analysis through binomial modeling showed that the odds of fusion of BCP&lt;μm was 2.54 times higher than that of autograft. 14% of patients experienced a procedure or possible device-related severe adverse event and there were four reoperations. Oswestry Disability Index (ODI) score decreased from a mean of 46.0 (±15.0) to a mean of 31.7 (±16.9), and 52.4% of patients improved with at least 15-point decrease.This data, aiming to determine non-inferiority of standalone BCP&lt;μm as compared to autograft for posterior spinal fusions, is promising. Ongoing studies to increase the power of the statistics with more patients are forthcoming.

Efficacy of a Standalone Microporous Ceramic vs. Autograft in Instrumented Posterolateral Spinal Fusion; a Multicenter, Randomized, Intra-patient Controlled, Non-inferiority Trial: Erratum.

Efficacy of a Standalone Microporous Ceramic vs. Autograft in Instrumented Posterolateral Spinal Fusion; a Multicenter, Randomized, Intra-patient Controlled, Non-inferiority Trial: Erratum.

Long-term (>\u200910\xa0years) clinical outcomes of instrumented posterolateral fusion for spondylolisthesis

PurposeDespite the rapid increase in instrumented spinal fusions for a variety of indications, most studies focus on short-term fusion rates. Long-term clinical outcomes are still scarce and inconclusive. This study investigated clinical outcomes > 10 years after single-level instrumented posterolateral spinal fusion for lumbar degenerative or isthmic spondylolisthesis with neurological symptoms.MethodsCross-sectional long-term follow-up among the Dutch participants of an international multicenter randomized controlled trial comparing osteogenic protein-1 with autograft. Clinical outcomes were assessed using the Oswestry Disability Index (ODI), EQ-5D-3L and visual analogue scale (VAS) for leg and back pain, as well as questions on satisfaction with treatment and additional surgery.ResultsThe follow-up rate was 73% (41 patients). At mean 11.8 (range 10.1–13.7) years after surgery, a non-significant deterioration of clinical outcomes compared to 1-year follow-up was observed. The mean ODI was 20 ± 19, mean EQ-5D-3L index score 0.784 ± 0.251 and mean VAS for leg and back pain, respectively, 34 ± 33 and 31 ± 28. Multiple regression showed that diagnosis (degenerative vs. isthmic spondylolisthesis), graft type (OP-1 vs. autograft) and 1-year fusion status (fusion vs. no fusion) were not predictive for the ODI at long-term follow-up (p = 0.389). Satisfaction with treatment was excellent and over 70% of the patients reported lasting improvement in back and/or leg pain. No revision surgeries for non-union were reported.ConclusionThis study showed favourable clinical outcomes > 10 years after instrumented posterolateral spinal fusion and supports spondylolisthesis with neurological symptoms as indication for fusion surgery.

Efficacy of a Standalone Microporous Ceramic Versus Autograft in Instrumented Posterolateral Spinal Fusion: A Multicenter, Randomized, Intrapatient Controlled, Noninferiority Trial.

in the rest of the article written as patient- and observer-blinded, multicenter, randomized, intrapatient controlled, noninferiority trial. The aim of this study was to determine noninferiority of a biphasic calcium-phosphate (AttraX® Putty) as a bone graft substitute for autograft in instrumented posterolateral fusion (PLF). Spinal fusion with autologous bone graft is a frequently performed surgical treatment. Several drawbacks of autografting have driven the development of numerous alternatives including synthetic ceramics. However, clinical evidence for the standalone use of these materials is limited. This study included 100 nontraumatic adults who underwent a primary, single- or multilevel, thoracolumbar, instrumented PLF. After instrumentation and preparation for grafting, the randomized allocation side of AttraX® Putty was disclosed. Autograft was applied to the contralateral side of the fusion trajectory, so each patient served as his/her own control. For the primary efficacy outcome, PLF was assessed at 1-year follow-up on computed tomography scans. Each segment and side was scored as fused, doubtful fusion, or nonunion. After correction for multilevel fusions, resulting in a single score per side, the fusion performance of AttraX Putty was tested with a noninferiority margin of 15% using a 90% confidence interval (CI). There were 49 males and 51 females with a mean age of 55.4 ± 12.0 (range 27-79) years. Two-third of the patients underwent a single-level fusion and 62% an additional interbody fusion procedure. The primary analysis was based on 87 patients, including 146 instrumented segments. The fusion rate of AttraX Putty was 55% versus 52% at the autograft side, with an overall fusion rate of 71%. The 90% CI around the difference in fusion performance excluded the noninferiority margin (difference = 2.3%, 90% CI = -9.1% to +13.7%). The results of this noninferiority trial support the use of AttraX Putty as a standalone bone graft substitute for autograft in instrumented thoracolumbar PLF. 1.

MagnetOs, Vitoss, and Novabone in a Multi-endpoint Study of Posterolateral Fusion: A True Fusion or Not?

Study Design:This study was a multi-endpoint analysis of bone graft substitutes implanted as a standalone graft in a clinically relevant Ovine model of instrumented posterolateral spinal fusion (PLF).Objective:The objective of this study was to obtain high-quality evidence on the efficacy of commercial bone graft substitutes compared with autograft in instrumented PLF using a state-of-the-art model with a complete range of assessment techniques.Summary of Background Data:Preclinical and clinical data on the quality of spinal fusions obtained with bone graft substitutes are often limited. Calcium phosphates with submicron topography have shown promising results in PLF, as these are able to induce bone formation in tissues distant from the host bone, which facilitates bony union.Methods:Nine female, skeletally mature sheep (4–5 y) underwent posterior pedicle screw/rods instrumented PLF at L2–L3 and L4–L5 using the following bone graft materials as a standalone graft per spinal segment: (1) biphasic calcium phosphate with submicron topography (BCP<µm), (2) 45S5 Bioglass (BG), and (3) collagen-β-tricalcium phosphate with a 45S5 Bioglass adjunct (TCP/BG). Autograft bone (AB) was used as a positive control treatment. Twelve weeks after implantation, the spinal segments were evaluated by fusion assessment (manual palpation, x-ray, micro-computed tomography, and histology), fusion mass volume quantification (micro-computed tomography), range of motion (ROM) testing, histologic evaluation, and histomorphometry.Results:Fusion assessment revealed equivalence between AB and BCP<µm by all fusion assessment methods, whereas BG and TCP/BG led to significantly inferior results. Fusion mass volume was highest for BCP<µm, followed by AB, BG, and TCP/BG. ROM testing determined equivalence for spinal levels treated with AB and BCP<µm, while BG and TCP/BG exhibited higher ROM. Histologic evaluation revealed substantial bone formation in the intertransverse regions for AB and BCP<µm, whereas BG and TCP/BG grafts contained fibrous tissue and minimal bone formation. Histologic observations were supported by the histomorphometry data.Conclusions:This study reveals clear differences in efficacy between commercially available bone graft substitutes, emphasizing the importance of clinically relevant animal models with multiendpoint analyses for the evaluation of bone graft materials. The results corroborate the efficacy of calcium phosphate with submicron topography, as this was the only material that showed equivalent performance to autograft in achieving spinal fusion.

Biphasic calcium phosphate with submicron surface topography in an Ovine model of instrumented posterolateral spinal fusion.

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 (BCPgranules) or as granules embedded within a fast‐resorbing polymeric carrier (BCPputty) 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 BCPputty 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, BCPgranules and BCPputty, 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.

The effect of increased microporosity on bone formation within silicate-substituted scaffolds in an ovine posterolateral spinal fusion model.

This study compared the bone forming capacity of the same formulation of silicate-substituted bone graft substitute materials with different microporosity in an instrumented posterolateral spinal fusion ovine model. Materials with a strut porosity of (i) 22.5% (SiCaP) or (ii) 36.0% (SiCaP(+)) were packed along either side of the spine. Bone apposition rates, % new bone formation, % bone-implant contact, and % graft resorption were quantified at 8, 12, and 24 weeks post surgery. Computed Tomography (CT) was used to grade the formation of fusion bridges between vertebrae. Results showed no significant difference in bone apposition rates, % new bone formation, and % bone-implant contact when the two materials were compared. However, at 8 weeks, a significantly higher CT score was obtained in the SiCaP(+) group (0.83 ± 0.17) when compared with the SiCaP group (0.17 ± 0.17; p = 0.027). Significantly less scaffold remained in the SiCaP(+) group at 12 weeks (p = 0.018). Both SiCaP and SiCaP(+) formulations augmented bone formation. Increasing the strut porosity did not significantly increase bone formation however, at 8 weeks it promoted the formation of more highly mineralized bone resulting in a significantly higher CT score, suggesting the bone tissue formed was more mature. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 805-814, 2017.

A prospective, multi-center clinical and radiographic outcomes evaluation of ChronOS strip for lumbar spine fusion

This prospective clinical study evaluated the use of a composite bone void filler (ChronOS Strip, DePuy Synthes, West Chester, PA, USA), combined with bone marrow aspirate plus local autologous bone, in a series of patients undergoing instrumented posterolateral spinal fusion with interbody support. Seventy-six patients were enrolled and treated per protocol at 13 clinical sites. At 24months, 55/76 patients (72%) were evaluated, with 49/76 (65%) having sufficient data to determine the primary endpoint. The primary endpoint, posterolateral fusion success, was achieved in 48/54 (88.9%) patients at 12months and in 45/49 (91.8%) patients at 24months. At all follow-up time points, statistically significant improvements were observed when compared to baseline in back and leg pain and functional status as measured by visual analog scale, Oswestry Disability Index and 12-Item Short Form health surveys. This prospective multi-center series provides evidence that the composite bone void filler, when applied posterolaterally with instrumentation, bone marrow aspirate and/or local autologous bone and concomitant interbody support, can be used to achieve a successful posterolateral fusion, resulting in improvements in clinical outcomes in patients with degenerative disc disease.

The First Clinical Trial of Beta-Calcium Pyrophosphate as a Novel Bone Graft Extender in Instrumented Posterolateral Lumbar Fusion

BackgroundPorous β-calcium pyrophosphate (β-CPP) was developed to improve the fusion success of posterolateral lumbar fusion (PLF). The possibility of accomplishing PLF using a mixture of porous β-CPP and iliac bone was studied. This paper reports the radiologic results of PLF using the β-CPP plus autograft for lumbar degenerative disease as a bone graft extender.MethodsA prospective, case-matched, radiographic study evaluating the results of short segment lumbar fusion using a β-CPP plus autograft was performed to compare the efficacy of β-CPP plus autograft with that of an autograft alone for short segment lumbar fusion. Thirty one consecutive patients (46 levels) underwent posterolateral fusion with pedicle screw fixation and additional posterior lumbar interbody fusion. In all patients, 3 mL of β-CPP plus 3 mL of autogenous bone graft was placed randomly in one side of a posterolateral gutter, and 6 mL of autogenous iliac bone graft was placed on the other. The fusion rates, volumes of fusion masses, and bone absorption percentage were evaluated postoperatively using simple radiographs and 3 dimensional computed tomography (3D-CT) scans.ResultsThe control sides treated with an autograft showed significantly better Lenke scores than the study sides treated with β-CPP at 3 and 6 months postoperatively, but there was no difference between the two sides at 12 months. The fusion rates (confirmed by 3D-CT) were 87.0% in the β-CPP group and 89.1% in the autograft group, which were not significantly different. The fusion mass volumes and bone absorption percentage at 12 months postoperatively were 2.49 mL (58.4%) and 1.89 mL (69.5%) for the β-CPP and autograft groups, respectively, and mean fusion mass volume was significantly higher in the β-CPP group.Conclusionsβ-CPP combined with an autograft is as effective as autologous bone for grafting during instrumented posterolateral spinal fusion. These findings suggest that β-CPP bone chips can be used as a novel bone graft extender for short-segment posterolateral spinal fusion.

In situ local autograft for instrumented lower lumbar or lumbosacral posterolateral fusion

This study evaluated the effectiveness of local in situ autografts in instrumented posterolateral fusion of the lower lumbar or lumbosacral spine for treating degenerative spondylolisthesis. The subjects were 182 degenerative spondylolisthesis patients with spinal canal stenosis who, in one operation, underwent lumbar laminectomy with two-level (L3–4, L4–5 or L5–S1) transpedicle screw/rod system instrumentation and posterolateral fusion using autogenous spinous processes and laminae as the only source of bone grafts. The surgical results were assessed clinically and radiologically. All patients received follow-up for at least eighteen months. At the end of follow-up, bilateral fusion mass was radiographically confirmed in 113 (62%) patients, unilateral fusion mass was observed in fifty-seven (31%) patients, and twelve (7%) patients exhibited no fusion mass at the arthrodesis level. The clinical outcome was rated excellent/good in 138 (76%) patients, fair in thirty-five (19%) and poor in nine (5%). Use of in situ local autografts yields satisfactory clinical results in instrumented posterolateral spinal fusion. No significant correlation was noted between the level of arthrodesis and the radiological outcome, nor between the level of arthrodesis and the clinical outcome. Radiographic evaluation of bony fusion mass was not predictive of the clinical findings.

Costs and effects in lumbar spinal fusion. A follow-up study in 136 consecutive patients with chronic low back pain

Although cost-effectiveness is becoming the foremost evaluative criterion within health service management of spine surgery, scientific knowledge about cost-patterns and cost-effectiveness is limited. The aims of this study were (1) to establish an activity-based method for costing at the patient-level, (2) to investigate the correlation between costs and effects, (3) to investigate the influence of selected patient characteristics on cost-effectiveness and, (4) to investigate the incremental cost-effectiveness ratio of (a) posterior instrumentation and (b) intervertebral anterior support in lumbar spinal fusion. We hypothesized a positive correlation between costs and effects, that determinants of effects would also determine cost-effectiveness, and that posterolateral instrumentation and anterior intervertebral support are cost-effective adjuncts in posterolateral lumbar fusion. A cohort of 136 consecutive patients with chronic low back pain, who were surgically treated from January 2001 through January 2003, was followed until 2 years postoperatively. Operations took place at University Hospital of Aarhus and all patients had either (1) non-instrumented posterolateral lumbar spinal fusion, (2) instrumented posterolateral lumbar spinal fusion, or (3) instrumented posterolateral lumbar spinal fusion + anterior intervertebral support. Analysis of costs was performed at the patient-level, from an administrator's perspective, by means of Activity-Based-Costing. Clinical effects were measured by means of the Dallas Pain Questionnaire and the Low Back Pain Rating Scale at baseline and 2 years postoperatively. Regression models were used to reveal determinants for costs and effects. Costs and effects were analyzed as a net-benefit measure to reveal determinants for cost-effectiveness, and finally, adjusted analysis (for non-random allocation of patients) was performed in order to reveal the incremental cost-effectiveness ratios of (a) posterior instrumentation and (b) anterior support. The costs of non-instrumented posterolateral spinal fusion were estimated at DKK 88,285(95% CI 81,369;95,546), instrumented posterolateral spinal fusion at DKK 94,396(95% CI 89,865;99,574) and instrumented posterolateral lumbar spinal fusion + anterior intervertebral support at DKK 120,759(95% CI 111,981;133,738). The net-benefit of the regimens was significantly affected by smoking and functional disability in psychosocial life areas. Multi-level fusion and surgical technique significantly affected the net-benefit as well. Surprisingly, no correlation was found between treatment costs and treatment effects. Incremental analysis suggested that the probability of posterior instrumentation being cost-effective was limited, whereas the probability of anterior intervertebral support being cost-effective escalates as willingness-to-pay per effect unit increases. This study reveals useful and hitherto unknown information both about cost-patterns at the patient-level and determinants of cost-effectiveness. The overall conclusion of the present investigation is a recommendation to focus further on determinants of cost-effectiveness. For example, patient characteristics that are modifiable at a relatively low expense may have greater influence on cost-effectiveness than the surgical technique itself--at least from an administrator's perspective.

Platelet Gel (AGF) Fails to Increase Fusion Rates in Instrumented Posterolateral Fusions

Retrospective cohort study. To determine the effect on fusion of adding platelet gel to autologous iliac crest graft. Platelet gel is an osteoinductive material prepared by ultra-concentration of platelets and contains multiple growth factors. Proprietary commercial methods are available for harvesting autologous platelet gel concentrates for use as graft supplement in spine fusions. We reviewed 76 consecutive patients who underwent instrumented posterolateral lumbar fusion with autologous iliac crest bone graft mixed with autologous growth factor (AGF). A control group was randomly selected from patients who underwent instrumented posterolateral lumbar fusion with autologous bone graft alone. The groups were matched for age, sex, smoking history, and number of levels fused. Demographic, surgical, and clinical data were collected from medical records. Diagnosis of nonunion was based on exploration during revision surgery or evidence of nonunion on computerized tomography. The Fisher exact test was used to compare fusion rates. In both groups, mean age was 50 years, and 24% were smokers. The nonunion rate was 25% in the AGF group and 17% in the control group. This difference was not statistically significant (P = 0.18). Platelet gel preparation requires blood draws from the patient. This procedure adds to the risk and cost of surgery. The technique for AGF harvest evaluated in this study provides the highest concentration of platelets among the commercially available methods. Despite this, we showed that platelet gel failed to enhance fusion rate when added to autograft in patients undergoing instrumented posterolateral spinal fusion. The authors do not recommend the use of platelet gel to supplement autologous bone graft during instrumented posterolateral spinal fusion.

The effect of pulsed electromagnetic fields on instrumented posterolateral spinal fusion and device-related stress shielding.

This study was designed to examine stress-shielding effects on the spine caused by rigid implants and to investigate the effects of pulsed electromagnetic fields on the instrumented spine. To investigate the effects of pulsed electromagnetic fields on posterolateral spinal fusion, and to determine if osteopenia induced by rigid instrumentation can be diminished by pulsed electromagnetic fields. Although device-related osteopenia on vertebral bodies is of a great clinical importance, no method for preventing bone mineral loss in vertebrae by stiff spinal implants has been effective. Twenty-eight adult beagles underwent L5-L6 destabilization followed by posterolateral spinal fusion. The study was divided into four groups: 1) Group CNTL: without instrumentation, without pulsed electromagnetic fields, 2) Group PEMF: without Steffee, with pulsed electromagnetic fields, 3) Group INST: with Steffee, without pulsed electromagnetic fields, 4) Group PEMF + INST: with Steffee, with pulsed electromagnetic fields. At the end of 24 weeks, the dogs were killed, and L4-L7 segments were tested biomechanically without instrumentation. Radiographs and quantitative computed tomography assessed the condition of the fusion mass. Stress shielding was induced in the anterior vertebral bodies of L6 with the Steffee plates; bone mineral density was increased with the addition of pulsed electromagnetic fields, regardless of the presence or absence of fixation. A decrease in flexion and bending stiffness was observed in the Group INST; pulsed electromagnetic fields did increase the flexion stiffness regardless of the presence or absence of fixation, although this was not statistically significant. Use of pulsed electromagnetic fields has the potential to minimize device-related vertebral-bone mineral loss.