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The diagnosis of fracture nonunion following plate osteosynthesis is subjective and frequently ambiguous. Initially following osteosynthesis, loads applied to the bone are primarily transmitted through the plate. However, as callus stiffness increases, the callus is able to bear load proportional to its stiffness while forces through the plate decrease. The purpose of this study was to use a "smart" fracture plate to distinguish between phases of fracture healing by measuring forces transmitted through the plate. A wireless force sensor and small adapter were placed on the outside of a distal femoral locking plate. The adapter converts the slight bending of the plate under axial load into a transverse force which is measurable by the sensor. An osteotomy was created and then plated in the distal femur of biomechanical Sawbones. Specimens were loaded to simulate single‐leg stance first with the osteotomy defect empty (acute healing), then sequentially filled with silicone (early callus) and then polymethyl methacrylate (hard callus). There was a strong correlation between applied axial load and force measured by the "smart" plate. Data demonstrate statistically significant differences between each phase of healing with as little as 150 N of axial load applied to the femur. Forces measured in the plate were significantly different between acute (100%), early callus (66.4%), and hard callus (29.5%). This study demonstrates the potential of a "smart" fracture plate to distinguish between phases of healing. These objective data may enable early diagnosis of nonunion and enhance outcomes for patients. [ABSTRACT FROM AUTHOR]

Background Context: Achieving a successful spinal fusion requires the proper biological and biomechanical environment. Optimizing load-sharing in the interbody space can enhance bone formation. For anterior cervical discectomy and fusion (ACDF), loading and motion are largely dictated by the stiffness of the plate, which can facilitate a balance between stability and load-sharing. The advantages of load-sharing may be substantial for patients with comorbidities and in multilevel procedures where pseudarthrosis rates are significant.Purpose: We aimed to evaluate the efficacy of a novel elastically deformable, continuously load-sharing anterior cervical spinal plate for promotion of bone formation and interbody fusion relative to a translationally dynamic plate.Study Design/setting: An in vivo animal model was used to evaluate the effects of an elastically deformable spinal plate on bone formation and spine fusion.Methods: Fourteen goats underwent an ACDF and received either a translationally dynamic or elastically deformable plate. Animals were followed up until 18 weeks and were evaluated by plain x-ray, computed tomography scan, and undecalcified histology to evaluate the rate and quality of bone formation and interbody fusion.Results: Animals treated with the elastically deformable plate demonstrated statistically significantly superior early bone formation relative to the translationally dynamic plate. Trends in the data from 8 to 18 weeks postoperatively suggest that the elastically deformable implant enhanced bony bridging and fusion, but these enhancements were not statistically significant.Conclusions: Load-sharing through elastic micro-motion accelerates bone formation in the challenging goat ACDF model. The elastically deformable implant used in this study may promote early bony bridging and increased rates of fusion, but future studies will be necessary to comprehensively characterize the advantages of load-sharing through micro-motion. [ABSTRACT FROM AUTHOR]

The article presents a study which examines the effectiveness of patch and plug scaffold based on small intestinal submucosa (SIS) to facilitate the closure of anular defect and anular functional recovery after anulotomy and partial discectomy in sheep. It mentions that after the surgery the cascade of morphologic and functional degeneration was reduced and that the anular closure was enhanced. It is concluded that SIS-treated discs are effective in maintaining hydration and functional recovery.

Abstract: Background context: Accurate knowledge of the mechanical loads in the lumbar spine is critical to understanding the causes of degenerative disc disease and to developing suitable treatment options and functional disc replacements. To date, only indirect methods have been used to measure the forces developed in the spine in vivo. These methods are fraught with error, and results have never been validated using direct experimental measurements. Purpose: The major aims of this study were to develop a methodology to directly measure, in real time, the in vivo loading in the lumbar spine, to determine if the forces developed in the lumbar spine are dependent on activity and/or posture and to assess the baboon as an animal model for human lumbar spine research based on in vivo mechanical loading. Study design: Real-time telemetered data were collected from sensor-imbedded implants that were placed in the interbody space of the lumbar spines of two baboons. Methods: An interbody spinal implant was designed and instrumented with strain gauges to be used as a load cell. The implant was placed anteriorly in the lumbar spine of the baboon. Strain data were collected in vivo during normal activities and transmitted by means of a telemetry system to a receiver. The forces transmitted through the implant were calculated from the measured strain based on precalibration of the load cell. Measured forces were correlated to videotaped activities to elucidate trends in force level as a function of activity and posture over a 6-week period. The procedure was repeated in a second baboon, and data were recorded for similar activities. Results: Implants measured in vivo forces developed in the lumbar spine with less than 10% error. Loads in the lumbar spine are dependent on activity and posture. The maximum loads developed in the lumbar spine during normal (baboon) activities exceeded four times body weight and were recorded while animals were sitting flexed. Force data indicate similar trends between the human lumbar spine and the baboon lumbar spine. Conclusions: It is possible to monitor the real-time forces present in the lumbar spine. Force data correlate well to trends previously reported for in vivo pressure data. Results also indicate that the baboon may be an appropriate animal model for study of the human lumbar spine. [Copyright &y& Elsevier]

Background context: Destabilization of the lumbar spine results from sacrifice of the anterior longitudinal ligament and disc when removed for graft or cage placement. In a similar fashion, transection of the interspinous ligament during surgical approaches to the posterior spine may result in segmental instability. Such instability can cause abnormal motion or implant migration resulting in a higher incidence of pseudarthrosis. Small intestinal submucosa (SIS) is a naturally occurring extracellular collagen-based matrix, which is derived from porcine small intestine. SIS contains cytokines and growth factors and has been shown to act as a resorbable scaffold in vivo that promotes host soft tissue regeneration with little scar tissue formation. SIS can be manufactured in laminated sheets of various sizes and thicknesses for different indications. Successful applications of SIS in animals have included dural substitution, rotator cuff repair, vessel repair, abdominal and bladder wall repair, and others. However, SIS has not been investigated to determine its ability to facilitate regeneration of spinal ligaments.Purpose: The purpose of this pilot study was to evaluate the efficacy of SIS as a barrier to prevent interbody device migration, and to act as a scaffold for regeneration of the anterior longitudinal ligament (ALL) and posterior interspinous ligament (PISL) in a goat model. Study design/setting: The thoracolumbar spine of the goat was exposed surgically. After resection and removal of the ALL or PISL at alternating levels, either SIS was placed or no treatment was administered. New ligament formation and SIS resorption were monitored over a 12-week period. Outcome measures: Plain film radiographs and histomorphometry were used to assess the progress of healing over a 12-week time period. Methods: Four skeletally mature nubian-alpine crossbred goats were used in this study. Under general anesthesia, each T10 to L5 motion segment was exposed surgically. Both anterolateral and posterior approaches were performed simultaneously at each level. Anteriorly, alternating levels received either 1) anterior discectomy, sacrifice of ALL and placement of SIS (SIS group); 2) anterior discectomy, sacrifice of ALL and no SIS (surgical control group) or 3) no surgical intervention (nonoperative group). A solid interbody spacer was placed into the disc space after discectomy to deter spontaneous anterior interbody fusion. Posteriorly, alternating levels were treated with either 1) sacrifice of the PISL with placement of SIS (SIS group); 2) sacrifice of PISL and no SIS (surgical control group) or 3) no surgical intervention (nonoperative group). The SIS was secured to the adjacent superior and inferior spinous processes to create a tension-band effect. Animals were radiographed immediately postoperatively to confirm placement of interbody spacers and anchors and to serve as a baseline for monitoring interbody spacer positioning. After surgery, all animals were allowed unrestricted motion for 12 weeks. At the end of the 12-week period, animals were radiographed and euthanized. The lumbar spine was harvested en bloc and processed for decalcified histologic evaluation. The dorsal and ventral aspects of each motion segment were analyzed for signs of inflammation and scar tissue formation, residual SIS and regenerated ALL or PISL. Results: All animals tolerated the surgical procedure well, and there were no intraoperative or anesthesia-related complications. Twelve-week radiographs showed some evidence of ventral migration of the interbody spacers in several animals. Fifty percent (two of four) of spacers in surgical control group levels had migrated more than 10 mm (resulting in complete migration out of the disc space), whereas no spacers migrated completely out of levels with SIS placed. Gross analysis at necropsy indicated iatrogenic scar formation at operated levels, the degree of which was not different from surgical control group to SIS levels. Histologic evaluation of areas where the ALL had been removed indicated formation of organized fibrilar collagenous tissue that spanned the disc space at some levels where the SIS was placed. In some cases, the newly formed tissue was approximately the thickness of the ALL at the nonoperative group levels. The newly formed collagenous tissue was accompanied by sparse focal areas of inflammation, with small fragments of residual SIS at some levels. At surgical control group levels, there was a varying degree of connective tissue that ranged from moderately organized to randomly oriented with no significant signs of inflammation. Similarly, histologic analysis of some levels where SIS was placed posteriorly showed formation of organized collagenous tissues where the PISL had been removed. Conclusions: In this model, the SIS patch was sufficient to prevent acute ventral migration of interbody spacers from the disc space. The extent of long-term healing and new tissue formation in the SIS group indicates that it may be efficacious as a reparative intervention for transected ligaments in the spine. Most SIS specimens showed formation of organized collagenous tissue, indicating a long-term potential for ligament formation. However, in this model, 12 weeks of postoperative healing is insufficient to assess the full potential of SIS as a spinal ligament repair. Further research that follows the healing process to a longer time point postoperatively may be necessary to fully understand the potential of SIS as a resorbable scaffold for tissue replacement. [Copyright &y& Elsevier]

Background: The intervertebral disc degenerates with age and has a poor propensity for regeneration. Small molecule transport plays a key role in long-term degradation and repair. Convection (bulk flow), induced by low rate cyclic loading of the intervertebral disc, has been shown to increase transport of small molecules. However, the potential therapeutic benefit of low rate cyclic loading on degenerated discs has not been described. The purpose of this study was to determine if a sustained (daily) low rate cyclic loading regimen could slow, arrest, or reverse intervertebral disc degeneration in the rabbit lumbar spine. Methods: Fifty-six New Zealand white rabbits (>12 months old) were designated as either Control (no disc puncture), 8D (disc puncture followed by 8 weeks of degeneration), 16D (disc puncture followed by 16 weeks of degeneration), or Therapy (disc puncture followed by 8 weeks of degeneration and then 8 weeks of daily low rate cyclic loading). Specimens were evaluated by T2 mapping, Pfirrmann scale grading, nucleus volume, disc height index, disc morphology and structure, and proteoglycan content. Results: In every metric, mean values for the Therapy group fell between Controls and 8D animals. These results suggest that sustained low rate cyclic loading had a therapeutic effect on the already degenerated disc and the regimen promoted signs of regeneration. If these results translate clinically, this approach could fulfil a significant clinical need by providing a means of non-invasively treating intervertebral disc degeneration. [ABSTRACT FROM AUTHOR]

Smart implants have the potential to enable personalized care regimens for patients. However, the integration of smart implants into daily clinical practice is limited by the size and cost of available sensing technology. Passive resonant sensors are an attractive alternative to traditional sensing technologies because they obviate the need for on-sensor signal conditioning or telemetry and are substantially simpler, smaller, less expensive, and more robust than other sensing methods. We have developed a novel simple, passive sensing platform that is adaptable to a variety of applications. Sensors consist of only two disconnected parallel Archimedean spiral coils and an intervening solid dielectric layer. When exposed to force or pressure, the resonant frequency of the circuit shifts which can be measured wirelessly. We fabricated prototype pressure sensors and force sensors and compared their performance to a lumped parameter model which predicts sensor behavior. The sensors exhibited a linear response ( R 2 > 0.91) to dynamic changes in pressure or force with excellent sensitivity. Experimental data were within 13.3% and 6.2% of the values predicted by the model for force and pressure respectively. Results demonstrate that the sensors can be adapted to measure various measurands through a span of sensitivities and ranges by appropriate selection of the intervening layer. [ABSTRACT FROM AUTHOR]

Study Design. Experimental animal study of convective transport in the intervertebral disc. Objective. To quantify the effects of mechanical loading rate on net transport into the healthy and degenerative intervertebral disc in vivo. Summary of Background Data. Intervertebral disc degeneration is linked with a reduction in transport to the avascular disc. Enhancing disc nutrition is, therefore, a potential strategy to slow or reverse the degenerative cascade. Convection induced by mechanical loading is a potential mechanism to augment diffusion of small molecules into the disc. Methods. Skeletally mature New Zealand white rabbits with healthy discs and discs degenerated via needle puncture were subjected to low rate axial compression and distraction loading for 2.5, 5, 10, 15, or 20 minutes after a bolus administration of gadodiamide. Additional animals with healthy discs were subjected to high-rate loading for 10 minutes or no loading for 10 minutes. Transport into the disc for each loading regimen was quantified using post-contrast-enhanced magnetic resonance imaging. Results. Low-rate loading resulted in the rapid uptake and clearance of gadodiamide in the disc. Low-rate loading increased net transport into the nucleus by a mean 16.8% and 12.6% in healthy and degenerative discs, respectively. The kinetics of small molecule uptake and clearance were accelerated in both healthy and degenerative discs with low-rate loading. In contrast, high-rate loading reduced transport into nucleus by a mean 16.8%. Conclusion. These results illustrate that trans-endplate diffusion can be enhanced by forced convection in both healthy and degenerative discs in vivo. Mechanical loading-induced convection could offer therapeutic benefit for degenerated discs by enhancing uptake of nutrients and clearance of by-products. [ABSTRACT FROM AUTHOR]

Background context The intervertebral disc primarily relies on trans-endplate diffusion for the uptake of nutrients and the clearance of byproducts. In degenerative discs, diffusion is often diminished by endplate sclerosis and reduced proteoglycan content. Mechanical loading-induced convection has the potential to augment diffusion and enhance net transport into the disc. The ability of convection to augment disc transport is controversial and has not been demonstrated in vivo. Purpose To determine if loading-induced convection can enhance small molecule transport into the intervertebral disc in vivo. Study design Net transport was quantified via postcontrast enhanced magnetic resonance imaging (MRI) into the discs of the New Zealand white rabbit lumbar spine subjected to in vivo cyclic low rate loading. Methods Animals were administered the MRI contrast agent gadodiamide intravenously and subjected to in vivo low rate loading (0.5 Hz, 200 N) via a custom external loading apparatus for either 2.5, 5, 10, 15, or 20 minutes. Animals were then euthanized and the lumbar spines imaged using postcontrast enhanced MRI. The T1 constants in the nucleus, annulus, and cartilage endplates were quantified as a measure of gadodiamide transport into the loaded discs compared with the adjacent unloaded discs. Microcomputed tomography was used to quantify subchondral bone density. Results Low rate loading caused the rapid uptake and clearance of gadodiamide in the nucleus compared with unloaded discs, which exhibited a slower rate of uptake. Relative to unloaded discs, low rate loading caused a maximum increase in transport into the nucleus of 16.8% after 5 minutes of loading. Low rate loading increased the concentration of gadodiamide in the cartilage endplates at each time point compared with unloaded levels. Conclusions Results from this study indicate that forced convection accelerated small molecule uptake and clearance in the disc induced by low rate mechanical loading. Low rate loading may, therefore, be therapeutic to the disc as it may enhance the nutrient uptake and waste product clearance. [ABSTRACT FROM AUTHOR]

ABSTRACT Intervertebral disc health is mediated in part by nutrient diffusion from the microvasculature in the adjacent subchondral bone. Evidence suggests that a reduction in nutrient diffusion contributes to disc degeneration, but the role of the microvasculature is unclear. The purpose of this study was to induce changes in the endplate microvasculature in vivo via pharmaceutical intervention and then correlate microvasculature characteristics to diffusion and disc health. New Zealand white rabbits were administered either nimodipine (to enhance microvessel density) or nicotine (to diminish microvessel density) daily for 8 weeks compared to controls. Trans-endplate diffusion and disc health were quantified using post-contrast enhanced magnetic resonance imaging (MRI). Histology was utilized to assess changes to the subchondral vasculature. Results indicate that nimodipine increased vessel area and vessel-endplate contact length, causing a significant increase in disc diffusion. Surprisingly, nicotine caused increases in vessel number and area but did not alter diffusion into the disc. The drug treatments did affect the microvasculature and diffusion, but the relationship between the two is complex and dependent on multiple factors which include vessel-endplate distance, and vessel-endplate contact length in addition to vessel density. Our data suggest that drugs can modulate these factors to augment or diminish small molecule transport. © 2014 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 32:1694-1700, 2014. [ABSTRACT FROM AUTHOR]

Study Design: After undergoing anulotomy, lumbar intervertebral discs from sheep were treated with small intestinal submucosa (SIS) and assessed functionally at 24 weeks after surgery. Objective: To determine the efficacy of an SIS-based patch and plug scaffold to facilitate anular defect closure and anular functional recovery after anulotomy and partial discectomy. Summary Of Background Data: The incidence of reherniation following discectomy remains high and mechanical means of anular closure have met with limited success. SIS is a naturally occurring collagen-based material, which acts as a resorbable scaffold in vivo that promotes soft tissue regeneration. Methods: Twelve sheep underwent retroperitoneal exposure of the lumbar spine. Three levels were assigned to either: no additional procedure, box anulotomy alone, or box anulotomy followed by placement of an SIS "patch and plug" anchored by titanium bone screws. At 26 weeks after surgery, 18 motion segments underwent pressure-volume testing to assess the competency of the anulus. High resolution MRI images were taken of the remaining 18 segments. Undecalcified histology was conducted on all specimens. Results: Radiographs, MRI images, and histology indicate that there was an exuberant tissue response at SIS-treated levels. New tissue formation in SIS-treated specimens was integrated well with the native anulus, but did not resemble the organization of native anulus. The extent of anular closure was substantial enough to allow the disc a functional recovery to a mean 66% of its capacity to develop internal pressure. MRI images indicate that SIS-treated levels did not maintain signal intensity comparable to exposure-only (intact) levels, but SIS-treated discs were statistically significantly higher than anulotomy-only levels. Conclusion: SIS-treated discs were better able to maintain hydration and resulted in a functional recovery relative to anulotomy alone levels. The SIS patch and plug reduced the cascade of functional degeneration that an intervertebral disc undergoes following anulotomy. [ABSTRACT FROM AUTHOR]