The Osteogenic Peptide P-15 for Bone Regeneration: A Narrative Review of the Evidence for a Mechanism of Action.

Bone regeneration is a complex multicellular process involving the recruitment and attachment of osteoprogenitors and their subsequent differentiation into osteoblasts that deposit extracellular matrixes. There is a growing demand for synthetic bone graft materials that can be used to augment these processes to enhance the healing of bone defects resulting from trauma, disease or surgery. P-15 is a small synthetic peptide that is identical in sequence to the cell-binding domain of type I collagen and has been extensively demonstrated in vitro and in vivo to enhance the adhesion, differentiation and proliferation of stem cells involved in bone formation. These events can be categorized into three phases: attachment, activation and amplification. This narrative review summarizes the large body of preclinical research on P-15 in terms of these phases to describe the mechanism of action by which P-15 improves bone formation. Knowledge of this mechanism of action will help to inform the use of P-15 in clinical practice as well as the development of methods of delivering P-15 that optimize clinical outcomes.

Effect of Device Constraint: A Comparative Network Meta-Analysis of ACDF and Cervical Disc Arthroplasty.

BACKGROUND CONTEXT: Clinical trials have demonstrated that cervical disc arthroplasty (CDA) is an effective and safe alternative treatment to anterior cervical discectomy and fusion (ACDF) for cervical degenerative disc disease in the appropriately indicated patient population. Various devices for CDA exist, differing in the level of device constraint. PURPOSE: To investigate outcomes following Anterior Cervical Discectomy and Fusion (ACDF) versus CDA stratified based on the level of device constraint: Constrained, Semi-constrained, and Unconstrained. STUDY DESIGN: Systematic review and network meta-analysis. PATIENT SAMPLE: 2,932 CDA patients (979 Constrained, 1214 Semi-Constrained, 739 Unconstrained) and 2,601 ACDF patients from 41 studies that compared outcomes of patients undergoing CDA or ACDF at a single level at a minimum of 2 years follow-up. OUTCOME MEASURES: Outcomes of interest included the development of adjacent segment degeneration (ASD), index and adjacent segment reoperation rates, range of motion (ROM), high-grade heterotopic ossification (HO, McAfee Grades 3/4), and patient-reported outcomes (NDI/VAS). METHODS: CDA devices were grouped based on the degrees of freedom (DoF) allowed by the device, as either Constrained (3 DoF), Semi-constrained (4 or 5 DoF), or Unconstrained (6 DoF). A random effects network meta-analysis was conducted using standardized mean differences (SMD) and log relative risk (RR) were used to analyze continuous and categorical data, respectively. RESULTS: Semi-constrained (p=0.03) and Unconstrained CDA (p=0.01) demonstrated a significantly lower risk for ASD than ACDF. All levels of CDA constraint demonstrated a significantly lower risk for subsequent adjacent segment surgery than ACDF (p<0.001). Semi-constrained CDA also demonstrated a significantly lower risk for index level reoperation than both ACDF and Constrained CDA (p<0.001). Unconstrained devices retained significantly greater ROM than both Constrained and Semi-Constrained CDA (p<0.001). As expected, all levels of device constraint retained significantly greater ROM than ACDF (p<0.001). Constrained and Unconstrained devices both demonstrated significantly lower levels of disability on NDI than ACDF (p=0.02). All levels of device constraint demonstrated significantly less neck pain than ACDF (p<0.05), while Unconstrained CDA had significantly less arm pain than ACDF (p=0.02) at final follow-up greater than 2 years. CONCLUSION: Cervical Disc Arthroplasty, particularly the unconstrained and semi-constrained designs, appears to be more effective than ACDF in reducing the risk of adjacent segment degeneration and the need for further surgeries, while also allowing for greater range of motion and better patient-reported outcomes. Less constrained CDA conferred a lower risk for index level reoperation, while also retaining more range of motion than more constrained devices.

Are carfentanil and acrylfentanyl naloxone resistant?

The rapid rise in deaths since 2012 due to opioid poisoning is correlated with the proliferation of potent synthetic opioid agonists such as fentanyl, acrylfentanyl, and carfentanil. The efficacy of frontline antidotes such as naloxone in reversing such poisoning events has been questioned, and the possibility of naloxone-resistant synthetic opioids has been raised. In this manuscript, we applied in vitro techniques to establish the median effective inhibitory concentrations for fentanyl, acrylfentanyl, and carfentanil and subsequently evaluate naloxone's ability to reverse agonist-receptor interactions.

Evaluation of Self-Inflicted versus Non-Self-Inflicted Gunshot Wounds and Associated Injuries Involving the Hand and Upper Extremity.

Orthopedic costs associated with gunshot wounds (GSWs) totaled approximately USD 510 million from 2005 to 2014. Previous studies have identified differences in injuries associated with self-inflicted (SI) GSWs; however, there remains a gap in understanding injury patterns. This study aims to expand upon the current literature and shed light on injury patterns and outcomes associated with SI vs. non-self-inflicted (NSI) GSWs. This is a retrospective cohort study of upper extremity GSWs from January 2012 to December 2022. Data were analyzed using the two-sample t-test, Pearson's chi-squared test, and Fisher's exact test. SI GSWs tended to be high-velocity GSWs and occurred more often in distal locations compared to NSI GSWs (p = 0.0014 and p < 0.0001, respectively). SI GSWs were associated with higher Gustilo-Anderson (GA) and Tscherne classifications (p < 0.0001 and p = 0.0048, respectively) and with a greater frequency of neurovascular damage (p = 0.0048). There was no difference in fracture rate or need for operative intervention between the groups. GA and Tscherne classifications were associated with the need for and type of surgery (p < 0.0001), with a higher classification being associated with more intricate operative intervention; however, GSW velocity was not associated with operative need (p = 0.42). Our findings demonstrate that velocity, wound grading systems, and other factors are associated with the manner in which GSWs to the upper extremity are inflicted and may thus have potential for use in the prediction of injury patterns and planning of trauma management and surgical intervention.

Comapping Cellular Content and Extracellular Matrix with Hemodynamics in Intact Arterial Tissues Using Scanning Immunofluorescent Multiphoton Microscopy.

Deviation of blood flow from an optimal range is known to be associated with the initiation and progression of vascular pathologies. Important open questions remain about how the abnormal flow drives specific wall changes in pathologies such as cerebral aneurysms where the flow is highly heterogeneous and complex. This knowledge gap precludes the clinical use of readily available flow data to predict outcomes and improve treatment of these diseases. As both flow and the pathological wall changes are spatially heterogeneous, a crucial requirement for progress in this area is a methodology for acquiring and comapping local vascular wall biology data with local hemodynamic data. Here, we developed an imaging pipeline to address this pressing need. A protocol that employs scanning multiphoton microscopy was developed to obtain three-dimensional (3D) datasets for smooth muscle actin, collagen, and elastin in intact vascular specimens. A cluster analysis was introduced to objectively categorize the smooth muscle cells (SMC) across the vascular specimen based on SMC actin density. Finally, direct quantitative comparison of local flow and wall biology in 3D intact specimens was achieved by comapping both heterogeneous SMC data and wall thickness to patient-specific hemodynamic results.

An Immunologic and Biomechanical Comparison of Polyether Ether Ketone-Zeolite and Polyether Ether Ketone Interbody Fusion Devices.

STUDY DESIGN: A laboratory study comparing polyether ether ketone (PEEK)-zeolite and PEEK spinal implants in an ovine model. OBJECTIVE: This study challenges a conventional spinal implant material, PEEK, to PEEK-zeolite using a nonplated cervical ovine model. SUMMARY OF BACKGROUND DATA: Although widely used for spinal implants due to its material properties, PEEK is hydrophobic, resulting in poor osseointegration, and elicits a mild nonspecific foreign body response. Zeolites are negatively charged aluminosilicate materials that are hypothesized to reduce this pro-inflammatory response when used as a compounding material with PEEK. MATERIALS AND METHODS: Fourteen skeletally mature sheep were, each, implanted with one PEEK-zeolite interbody device and one PEEK interbody device. Both devices were packed with autograft and allograft material and randomly assigned to one of 2 cervical disc levels. The study involved 2 survival time points (12 and 26 weeks) and biomechanical, radiographic, and immunologic endpoints. One sheep expired from complications not related to the device or procedure. A biomechanical evaluation was based on measures of segmental flexibility, using 6 degrees of freedom pneumatic spine tester. Radiographic evaluation was performed using microcomputed tomography scans in a blinded manner by 3 physicians. Levels of the pro-inflammatory cytokines, interleukin (IL)-1ß, IL-6, and tumor necrosis factor-alpha at the implant, were quantified using immunohistochemistry. RESULTS: PEEK-zeolite and PEEK exhibited an equivalent range of motion in flexion extension, lateral bending, and axial torsion. A motion was significantly reduced for implanted devices at both time points as compared with native segments. Radiographic assessments of fusion and bone formation were similar for both devices. PEEK-zeolite exhibited lower levels of IL-1ß ( P = 0.0003) and IL-6 ( P = 0.03). CONCLUSION: PEEK-zeolite interbody fusion devices provide initial fixation substantially equivalent to PEEK implants but exhibit a reduced pro-inflammatory response. PEEK-zeolite devices may reduce the chronic inflammation and fibrosis previously observed with PEEK devices.

Biomechanical Stability of Primary and Revision Sacroiliac Joint Fusion Devices: A Cadaveric Study.

STUDY DESIGN: An in vitro biomechanics study. OBJECTIVE: To evaluate the efficacy of triangular titanium implants in providing mechanical stabilization to a sacroiliac joint with primary and revision sized implants. METHODS: Ten lumbopelvic cadaveric specimens were tested in 4 stages: intact, pubic symphysis sectioned, primary, and simulated revision. Primary treatment was performed using 3 laterally placed triangular titanium implants. To simulate revision conditions before and after bone ingrowth and ongrowth on the implants, 7.5-mm and 10.75-mm implants were randomly assigned to one side of each specimen during the simulated revision stage. A 6 degrees of freedom spinal loading frame was used to load specimens in 4 directions: flexion extension, lateral bending, axial torsion, and axial compression. Biomechanical evaluation was based on measures of sacroiliac joint rotational and translational motion. RESULTS: Both primary and revision implants showed the ability to reduce translational motion to a level significantly lower than the intact condition when loaded in axial compression. Simulated revision conditions showed no statistically significant differences compared with the primary implant condition, with the exception of flexion-extension range of motion where motions associated with the revised condition were significantly lower. Comparison of rotational and translation motions associated with the 7.5- and 10.75-mm implants showed no significant differences between the treatment conditions. CONCLUSIONS: These results indicate that implantation of laterally placed triangular titanium implants significantly reduces the motion of a sacroiliac joint using either the primary and revision sized implants. No statistically significant differences were detected when comparing the efficacy of primary, 7.5-mm revision, or 10.75-mm revision implants.

Grafting Polymer Brushes by ATRP from Functionalized Poly(ether ether ketone) Microparticles.

Poly(ether ether ketone) (PEEK) is a semi-crystalline thermoplastic with excellent mechanical and chemical properties. PEEK exhibits a high degree of resistance to thermal, chemical, and bio-degradation. PEEK is used as biomaterial in the field of orthopaedic and dental implants; however, due to its intrinsic hydrophobicity and inert surface, PEEK does not effectively support bone growth. Therefore, new methods to modify PEEK's surface to improve osseointegration are key to next generation polymer implant materials. Unfortunately, PEEK is a challenging material to both modify and subsequently characterize thus stymieing efforts to improve PEEK osseointegration. In this manuscript, we demonstrate how surface-initiated atom transfer radical polymerization (SI-ATRP) can be used to modify novel PEEK microparticles (PMP). The hard core-soft shell microparticles were synthesized and characterized by DLS, ATR-IR, XPS and TEM, indicating the grafted materials increased solubility and stability in a range of solvents. The discovered surface grafted PMP can be used as compatibilizers for the polymer-tissue interface.

A Deep Learning Model for Automated Classification of Intraoperative Continuous EMG.

OBJECTIVE: Intraoperative neurophysiological monitoring (IONM) is the use of electrophysiological methods during certain high-risk surgeries to assess the functional integrity of nerves in real time and alert the surgeon to prevent damage. However, the efficiency of IONM in current practice is limited by latency of verbal communications, inter-rater variability, and the subjective manner in which electrophysiological signals are described. METHODS: In an attempt to address these shortcomings, we investigate automated classification of free-running electromyogram (EMG) waveforms during IONM. We propose a hybrid model with a convolutional neural network (CNN) component and a long short-term memory (LSTM) component to better capture complicated EMG patterns under conditions of both electrical noise and movement artifacts. Moreover, a preprocessing pipeline based on data normalization is used to handle classification of data from multiple subjects. To investigate model robustness, we also analyze models under different methods for processing of artifacts. RESULTS: Compared with several benchmark modeling methods, CNN-LSTM performs best in classification, achieving accuracy of 89.54% and sensitivity of 94.23% in cross-patient evaluation. CONCLUSION: The CNN-LSTM model shows promise for automated classification of continuous EMG in IONM. SIGNIFICANCE: This technique has potential to improve surgical safety by reducing cognitive load and inter-rater variability.

A successful, cost-effective low back pain triage system: a pilot study.

BACKGROUND: Effective triage - directing patients with low back pain to appropriate treatment or correct referral - is fundamental to quality care. Without guidelines, a physician's initial decision may lead to unnecessary investigation, unneeded intervention or unwarranted consultation. Methods: To compare the functional outcomes of patients triaged by a classification based on clinical presentation with those of patients selected at the clinicians' discretion, an insurance-owned hospital network employed forty-seven specially-trained physical therapists, working within participating primary care practices, to classify low back pain patients into specific Patterns of Pain. Between October 2017 and April 2019, the primary care physicians used this classification, derived entirely from the patient's history and physical examination, to direct subsequent treatment for 260 consecutive low back pain patients. Patients with systemic symptoms, recent substantial trauma or non-mechanical diagnoses indicative of spinal infections or possible malignancy were excluded. Functional outcome measures were spinal imaging, opioid use, length of treatment and number of visits, back-related unplanned care, frequency of spinal surgery and back-related episode cost. These were compared with a control group of 256 propensity-matched patients and, for assessing the financial impact, with a historic cohort of 111 previously treated, non-classified patients. Results: Spinal imaging: study group 24.5%; controls 42.2% (P< .001). Narcotic use: study group 4.6%; controls 13.3% (P< .001). Treatment length: study group 62.2 days; controls 74.5 days (P=.10). Treatment visits: study group 1528 visits; controls 2,046 visits (P=.003). Unplanned care: study group 1.9%; controls 12.8% (P< .001). Spine surgery: study group 15.4%; controls 26.2% (P=.005). Episode cost: study group $1453; controls $2334 (P=.005). Conclusions: A well-defined clinically-based triage system produced meaningful reductions in imaging, opioid use, treatment duration, unplanned interventions, surgery and cost of care.

Current Concepts of Contemporary Expandable Lumbar Interbody Fusion Cage Designs, Part 2: Feasibility Assessment of an Endplate Conforming Bidirectional Expandable Interbody Cage.

BACKGROUND: Expandable cages that allow for bidirectional expansion, in both height and width, may offer benefits over traditional expandable cages or static cages. Effective stiffness must also be considered, as implants with exceedingly high stiffness may increase subsidence risk and reduce graft loading. METHODS: A retrospective case series of 7 patients were assessed with computed tomography (CT) scan at the final 1-year follow-up to evaluate the interbody fusion and configuration of the expandable cage related to the endplates within the intervertebral space. CT scans were reformatted using cage's tantalum markers as fiducials for single-plane orientation for each intervertebral cage. Device height and width at maximum in situ expansion was measured at its anterior and posterior aspects to evaluate implant deformation. The new bone volume within each cage was measured from the same CT scan data sets and by the Bridwell classification of interbody fusion. RESULTS: The average difference between medial and lateral height measurements was 1.82 mm (±1.08) at the device's anterior aspect and 1.41 mm (±0.98) at the posterior aspect. The average difference between medial and lateral heights was 18.55% (±9.34) anteriorly and 15.49% (±9.24) posteriorly. There was a successful fusion in all 7 patients, as evidenced by measurable bone volume in the center of each interbody cage with an average of 586.42 mm3 (±237.06). CONCLUSION: The authors demonstrated the feasibility of successfully using bidirectionally expandable multimaterial cages to achieve interbody fusion. These composite open-architecture cages were found to conform to each patient's endplate configuration. The authors' observations support the concept of material selection impacting the effective construct stiffness. The design investigated by the authors provided sufficient anterior column support and successful fusion in all patients. LEVEL OF EVIDENCE: 4.

Current Concepts of Contemporary Expandable Lumbar Interbody Fusion Cage Designs, Part 1: An Editorial on Their Biomechanical Characteristics.

BACKGROUND: Bidirectional expandable designs for lumbar interbody fusion cages are the latest iteration of expandable spacers employed to address some of the common problems inherent to static interbody fusion cages. OBJECTIVE: To describe the rationales for contemporary bidirectional, multimaterial expandable lumbar interbody fusion cage designs to achieve in situ expansion for maximum anterior column support while decreasing insertion size during minimal-access surgeries. METHODS: The authors summarize the current concepts behind expandable spinal fusion open architecture cage designs focusing on advanced minimally invasive spinal surgery techniques, such as endoscopy. A cage capable of bidirectional expansion in both height and width to address constrained surgical access problems was of particular interest to the authors while they analyzed the relationship between implant material stiffness and geometric design regarding the risk of subsidence and reduced graft loading. CONCLUSIONS: Biomechanical advantages of new bidirectional, multimaterial expandable interbody fusion cages allow insertion through minimal surgical access and combine the advantages of proven device configurations and advanced material selection. The final construct stiffness is sufficient to provide immediate anterior column support while accommodating reduced sizes required for minimally invasive surgery applications. LEVEL OF EVIDENCE: 7.

Bidirectional Expandable Technology for Transforaminal or Posterior Lumbar Interbody Fusion: A Retrospective Analysis of Safety and Performance.

BACKGROUND: Expandable devices for transforaminal or posterior lumbar interbody fusion (TLIF and PLIF, respectively) may enable greater restoration of disc height, foraminal height, and stability within the interbody space than static spacers. Medial-lateral expansion may also increase stability and resistance to subsidence. This study evaluates the clinical and radiographic outcomes from early experience with a bidirectional expandable device. METHODS: This was a retrospective analysis of a continuous series of patients across 3 sites who had previously undergone TLIF or PLIF surgery with a bidirectional expandable interbody fusion device (FlareHawk, Integrity Implants, Inc) at 1 or 2 contiguous levels between L2 and S1. Outcomes included the Oswestry Disability Index (ODI), a visual analog scale (VAS) for back pain or leg pain, radiographic fusion by 1 year of follow-up, subsidence, device migration, and adverse events (AE). RESULTS: There were 58 eligible patients with radiographs for 1-year fusion assessments and 45 patients with ODI, VAS back pain, or VAS leg pain data at baseline and a mean follow-up of 4.5 months. The ODI, VAS back pain, and VAS leg pain scores improved significantly from baseline to final follow-up, with mean improvements of 14.6 ± 19.1, 3.4 ± 2.6, and 3.9 ± 3.4 points (P < .001 for each), respectively. In addition, 58% of patients achieved clinically significant improvements in ODI, 76% in VAS back pain, and 71% in VAS leg pain. By 1 year, 96.6% of patients and 97.4% of levels were considered fused. There were zero cases of device subsidence and 1 case of device migration (1.7%). There were zero device-related AEs, 1 intraoperative dural tear, and 3 subsequent surgical interventions. CONCLUSIONS: The fusion rate, improvements in patient-reported outcomes, and the AEs observed are consistent with those of other devices. The bidirectional expansion mechanism may provide other important clinical value, but further studies will be required to elucidate the unique advantages. LEVEL OF EVIDENCE: 4.

Prevention of Implant-Associated Infection in Neuromodulation: Review of the Literature and Prototype of a Novel Protective Implant Coating.

Background: Implanting hardware into surgical sites increases the rate of infection associated with these sites. Without novel efforts to reduce this rate of infection, we can expect to see an increase in the number of hardware-associated infections as more patients are implanted with these devices. These infections often necessitate the removal of these devices resulting in a significant financial and clinical burden to patients. We developed a prototype antibiotic coating using products that are both low cost and that can be sourced easily. Our study aims to test the effectiveness of this coating against bacteria commonly observed in hospital-associated infections. Methods: The antibiotic coating was prepared by combining one gram of vancomycin and 500 mg of ciprofloxacin in 50 mL of glycerol. The coating was examined for inhibition of growth of Pseudomonas aeruginosa PA14 and Staphylococcus aureus AH2486 and compared with the bacterial growth of the above bacteria in glycerol alone. The growth curves were plotted measuring the bacterial growth at 5 h intervals. Results: The results of the growth curves clearly demonstrate a lack of bacterial growth when these bacteria are combined with glycerol combined with our selected antibiotic agents. Conclusion: There appears to be a limited interest from device companies in developing new strategies for infection prevention associated with neurosurgical hardware, and we propose that this prototype will be an effective and low-cost solution to a large problem.

A comparative study of three biomaterials in an ovine bone defect model.

BACKGROUND: Polyetheretherketone (PEEK), and more recently titanium-coated PEEK, have been given serious consideration as biomaterial design choices for spinal interbody implants. Shortcomings in these materials necessitate further innovation into materials research, for example, on PEKK. Common complications such as surface delamination (as with titanium coating) and lack of bone apposition (as with PEEK) indicate the need for a new material that inherently displays preferable bone growth characteristics without sacrificing structural integrity. PURPOSE: To compare three biomaterials with respect to their osseointegrative capacity. STUDY DESIGN: Evaluate the in vivo material characteristics of three separate biomaterials in an ovine bone defect model: PEEK, titanium-coated PEEK (Ti-coated PEEK), and 3D-printed PEKK. Biomechanical, histologic, and radiographic testing was the basis for evaluation and material characterization. METHODS: Eight ovine specimens were implanted with one of each of the three types of biomaterials tested in both left and right epicondyles using a femoral bone defect model, and were sacrificed at 8 and 16 weeks. Implants were then analyzed using a push-out method, histologic staining, and various radiographic tests. Industry funding was provided for the completion of this research study, followed by an independent third party review of all relevant data for publication. RESULTS: PEKK implants demonstrated bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, significant increase in bony apposition over time, and significantly higher push-out strength compared to standard PEEK. The PEKK implant displayed bone growth characteristics comparable to Ti-coated PEEK with significant improvements in implant integrity and radiographic properties. CONCLUSION: This study found that PEKK displayed preferable characteristics when compared to PEEK and Ti-coated PEEK, and is therefore a potential alternative to their use.

Porous titanium-coated polyetheretherketone implants exhibit an improved bone-implant interface: an in vitro and in vivo biochemical, biomechanical, and histological study.

PURPOSE: Spinal interbody fusion cages are designed to provide immediate stabilization for adjoining vertebrae and ideally enable bony ingrowth to achieve successful integration. For such an implant, cells must be able to attach, move, grow, and differentiate on its surface. These cellular interactions are dependent on how the implant surface enables the coating and binding of blood and tissue fluid proteins that support cell adhesion. The purpose of this study was to evaluate the in vitro and in vivo osteoblast cell-implant surface interactions that result in osseointegration onto a surface composed of plasma-sprayed titanium on a polyetheretherketone (PEEK) substrate or titanium-coated PEEK (Ti-PEEK) (PlasmaporeXP®) as compared to uncoated PEEK implants. MATERIALS AND METHODS: The influence of the Ti-PEEK surface modification on the biochemical, biomechanical, and histological properties at the bone-implant interface is demonstrated both in vitro using simulated bone-forming cell culture experiments and in vivo using a 12- and 24-week ovine implant model. RESULTS: Osteoblast-like cells attached to the Ti-PEEK surface upregulated early bone-forming activity as measured by an increase in transcription and translation of ALP and BMP-2 when compared to cells on PEEK. Similarly, a significant increase in new bone formation, bony apposition, and pullout strength was demonstrated on Ti-PEEK implants when compared to PEEK implants at 12 and 24 weeks in an ovine implant in vivo model. CONCLUSION: The study shows that the Ti-PEEK surface demonstrated enhanced osseointegrative properties compared to PEEK both in vitro and in vivo.

Disc nucleus fortification for lumbar degenerative disc disease: a biomechanical study.

OBJECTIVE Spinal stability is attributed in part to osteoligamentous structures, including the vertebral body, facets, intervertebral discs, and posterior elements. The materials in this study provide an opportunity to augment the degenerated nucleus without removing native disc material, a procedure introduced here as "fortification." The objective of this study was to determine the effect of nucleus fortification on lumbar disc biomechanics. METHODS The authors performed in vitro analysis of human cadaveric functional spinal units (FSUs), along with characterization and quantification of movement of the units using biomechanical data in intact, disc-only, and fortified specimens. The units underwent removal of all posterior elements and annulus and were fortified by injecting a biogel into the nucleus pulposus. Each specimen was subjected to load testing, range of motion (ROM) quantification, and disc bulge measurements. Optoelectric tracking was used to quantify disc bulge. These criteria were assessed in the intact, disc-only, and fortified treatments. RESULTS Disc-only FSUs resulted in increased ROM when compared with intact and fortified conditions. Fortification of the FSU resulted in partial restoration of normal ROM in the treatment groups. Analysis of hysteresis loops showed more linear response in the fortified groups when compared with the intact and disc-only groups. CONCLUSIONS Disc nucleus fortification increases linearity and decreases ROM.

Biomechanics of Posterior Dynamic Fusion Systems in the Lumbar Spine: Implications for Stabilization With Improved Arthrodesis.

STUDY DESIGN: A comparative biomechanical human cadaveric spine study of a dynamic fusion rod and a traditional titanium rod. OBJECTIVE: The purpose of this study was to measure and compare the biomechanical metrics associated with a dynamic fusion device, Isobar TTL Evolution, and a rigid rod. SUMMARY OF BACKGROUND DATA: Dynamic fusion rods may enhance arthrodesis compared with a rigid rod. Wolff's law implies that bone remodeling and growth may be enhanced through anterior column loading (AL). This is important for dynamic fusion rods because their purpose is to increase AL. METHODS: Six fresh-frozen lumbar cadaveric specimens were used. Each untreated specimen (Intact) underwent biomechanical testing. Next, each specimen had a unilateral transforaminal lumbar interbody fusion performed at L3-L4 using a cage with an integrated load cell. Pedicle screws were also placed at this time. Subsequently, the Isobar was implanted and tested, and finally, a rigid rod replaced the Isobar in the same pedicle screw arrangement. RESULTS: In terms of range of motion, the Isobar performed comparably to the rigid rod and there was no statistical difference found between Isobar and rigid rod. There was a significant difference between the intact and rigid rod and also between intact and Isobar conditions in flexion extension. For interpedicular displacement, there was a significant increase in flexion extension (P=0.017) for the Isobar compared with the rigid rod. Isobar showed increased AL under axial compression compared with the rigid rod (P=0.024). CONCLUSIONS: Isobar provided comparable stabilization to a rigid rod when using range of motion as the metric, however, AL was increased because of the greater interpedicular displacement of dynamic rod compared with a rigid rod. By increasing interpedicular displacement and AL, it potentially brings clinical benefit to procedures relying on arthrodesis.

In Vitro Comparison of Dynesys, PEEK, and Titanium Constructs in the Lumbar Spine.

Introduction. Pedicle based posterior dynamic stabilization systems aim to stabilize the pathologic spine while also allowing sufficient motion to mitigate adjacent level effects. Two flexible constructs that have been proposed to act in such a manner, the Dynesys Dynamic Stabilization System and PEEK rod, have yet to be directly compared in vitro to a rigid Titanium rod. Methods. Human lumbar specimens were tested in flexion extension, lateral bending, and axial torsion to evaluate the following conditions at L4-L5: Intact, Dynesys, PEEK rod, Titanium rod, and Destabilized. Intervertebral range of motion, interpedicular travel, and interpedicular displacement metrics were evaluated from 3rd-cycle data using an optoelectric tracking system. Results. Statistically significant decreases in ROM compared to Intact and Destabilized conditions were detected for the instrumented conditions during flexion extension and lateral bending. AT ROM was significantly less than Destabilized but not the Intact condition. Similar trends were found for interpedicular displacement in all modes of loading; however, interpedicular travel trends were less consistent. More importantly, no metrics under any mode of loading revealed significant differences between Dynesys, PEEK, and Titanium. Conclusion. The results of this study support previous findings that Dynesys and PEEK constructs behave similarly to a Titanium rod in vitro.

Comparison of Intervertebral ROM in Multi-Level Cadaveric Lumbar Spines Using Distinct Pure Moment Loading Approaches.

BACKGROUND: Pure-moment loading is the test method of choice for spinal implant evaluation. However, the apparatuses and boundary conditions employed by laboratories in performing spine flexibility testing vary. The purpose of this study was to quantify the differences, if they exist, in intervertebral range of motion (ROM) resulting from different pure-moment loading apparatuses used in two laboratories. METHODS: Twenty-four (laboratory A) and forty-two (laboratory B) intact L1-S1 specimens were loaded using pure moments (±7.5 Nm) in flexion-extension (FE), lateral bending (LB) and axial torsion (AT). At laboratory A, pure moments were applied using a system of cables, pulleys and suspended weights in 1.5 Nm increments. At laboratory B, specimens were loaded in a pneumatic biaxial test frame mounted with counteracting stepper-motor-driven biaxial gimbals. ROM was obtained in both labs using identical optoelectronic systems and compared. RESULTS: In FE, total L1-L5 ROM was similar, on average, between the two laboratories (lab A: 37.4° ± 9.1°; lab B: 35.0° ± 8.9°, p=0.289). Larger apparent differences, on average, were noted between labs in AT (lab A: 19.4° ± 7.3°; lab B: 15.7° ± 7.1°, p=0.074), and this finding was significant for combined right and left LB (lab A: 45.5° ± 11.4°; lab B: 35.3° ± 8.5°, p < 0.001). CONCLUSIONS: To our knowledge, this is the first study comparing ROM of multi-segment lumbar spines between laboratories utilizing different apparatuses. The results of this study show that intervertebral ROM in multi-segment lumbar spine constructs are markedly similar in FE loading. Differences in boundary conditions are likely the source of small and sometimes statistically significant differences between the two techniques in LB and AT ROM. The relative merits of each testing strategy with regard to the physiologic conditions that are to be simulated should be considered in the design of a study including LB and AT modes of loading. An understanding of these differences also serves as important information when comparing study results across different laboratories.