Cortical parameters predict bone strength at the tibial diaphysis, but are underestimated by HR-pQCT and µCT compared to histomorphometry.

Cortical bone and its microstructure are crucial for bone strength, especially at the long bone diaphysis. However, it is still not well-defined how imaging procedures can be used as predictive tools for mechanical bone properties. This study evaluated the capability of several high-resolution imaging techniques to capture cortical bone morphology and assessed the correlation with the bone's mechanical properties. The microstructural properties (cortical thickness [Ct.Th], porosity [Ct.Po], area [Ct.Ar]) of 11 female tibial diaphysis (40-90 years) were evaluated by dual-energy X-ray absorptiometry (DXA), high-resolution peripheral-quantitative-computed-tomography (HR-pQCT), micro-CT (µCT) and histomorphometry. Stiffness and maximal torque to failure were determined by mechanical testing. T-Scores determined by DXA ranged from 0.6 to -5.6 and a lower T-Score was associated with a decrease in Ct.Th (p ≤ 0.001) while the Ct.Po (p ≤ 0.007) increased, and this relationship was independent of the imaging method. With decreasing T-Score, histology showed an increase in Ct.Po from the endosteal to the periosteal side (p = 0.001) and an exponential increase in the ratio of osteons at rest to those after remodelling. However, compared to histomorphometry, HR-pQCT and µCT underestimated Ct.Po and Ct.Th. A lower T-Score was also associated with significantly reduced stiffness (p = 0.031) and maximal torque (p = 0.006). Improving the accuracy of Ct.Po and Ct.Th did not improve prediction of the mechanical properties, which was most closely related to geometry (Ct.Ar). The ex-vivo evaluation of mechanical properties correlated with all imaging modalities, with Ct.Th and Ct.Po highly correlated with the T-Score of the tibial diaphysis. Cortical microstructural changes were underestimated with the lower resolution of HR-pQCT and µCT compared to the histological 'gold standard'. The increased accuracy did not result in an improved prediction for local bone strength in this study, which however might be related to the limited number of specimens and thus needs to be evaluated in a larger collective.

Characterization of an ovine bilateral critical sized bone defect iliac wing model to examine treatment modalities based on bone tissue engineering.

Critical sized bone defect (CSBD) animal models are used to evaluate and confirm efficacy and potency of new treatment modalities based on bone tissue engineering before the latter can be applied in clinical practice. In this study, a bilateral CSBD model in the iliac wings of sheep is described in detail. To demonstrate that this is a large animal CSBD model in sheep, bone healing within the defect left empty (negative control) or filled with autologous corticocancellous bone graft (clinical gold standard, positive control) was assessed using micro-CT, histology, histomorphometric, and fluorochrome analysis. After three months, new bone into the defect site was formed across the whole defect in the positive controls but limited to the edge of the defects in the negative controls. Bone volume in the positive controls was statistically higher than in the negative controls, with the latter having less than 10% new bone growth. There were no intraoperative or postoperative complications. The model described here represents a reliable and reproducible bilateral CSBD in sheep with low morbidity that can be used for in vivo evaluation of new treatment modalities based on bone tissue engineering.

Mechanical assessment of local bone quality to predict failure of locked plating in a proximal humerus fracture model.

The importance of osteoporosis in proximal humerus fractures is well recognized. However, the local distribution of bone quality in the humeral head may also have a significant effect because it remains unclear in what quality of bone screws of standard implants purchase. The goal of this study was to investigate whether the failure of proximal humerus locked plating can be predicted by the DensiProbe (ARI, Davos, Switzerland). A 2-part fracture with metaphyseal impaction was simulated in 12 fresh-frozen human cadaveric humeri. Using the DensiProbe, local bone quality was determined in the humeral head in the course of 6 proximal screws of a standard locking plate (Philos; Synthes GmbH, Solothurn, Switzerland). Cyclic mechanical testing with increasing axial loading until failure was performed. Bone mineral density (BMD) significantly correlated with cycles until failure. Head migration significantly increased between 1000 and 2000 loading cycles and significantly correlated with BMD after 3000 cycles. DensiProbe peak torque in all screw positions and their respective mean torque correlated significantly with the BMD values. In 3 positions, the peak torque significantly correlated with cycles to failure; here BMD significantly influenced mechanical stability. The validity of the DensiProbe was proven by the correlation between its peak torque measurements and BMD. The correlation between the peak torque and cycles to failure revealed the potential of the DensiProbe to predict the failure of locked plating in vitro. This method provides information about local bone quality, potentially making it suitable for intraoperative use by allowing the surgeon to take measures to improve stability.

DensiProbe Spine: an intraoperative measurement of bone quality in spinal instrumentation. A clinical feasibility study.

BACKGROUND CONTEXT: A new device, DensiProbe, has been developed to provide surgeons with intraoperative information about bone strength by measuring the peak breakaway torque. In cases of low bone quality, the treatment can be adapted to the patient's condition, for example, by improving screw-anchorage with augmentation techniques. PURPOSE: The objective of this study was to investigate the feasibility of DensiProbe Spine in patients undergoing transpedicular fixation. STUDY DESIGN: Prospective feasibility study on consecutive patients. PATIENT SAMPLE: Fourteen women and 16 men were included in this study. OUTCOME MEASURES: Local and general bone quality. METHODS: These consecutive patients scheduled for transpedicular fixation were evaluated for bone mineral density (BMD), which was measured globally by dual-energy X-ray absorptiometry and locally via biopsies using quantitative microcomputed tomography. The breakaway torque force within the vertebral body was assessed intraoperatively via the transpedicular approach with the DensiProbe Spine. The results were correlated with the areal BMD at the lumbar spine and the local volumetric BMD (vBMD) and a subjective impression of bone strength. The feasibility of the method was evaluated, and the clinical and radiological performance was evaluated over a 1-year follow-up. This study was funded by an AO Spine research grant; DensiProbe was developed at the AO Research Institute Davos, Switzerland; the AO Foundation is owner of the intellectual property rights. RESULTS: In 30 patients, 69 vertebral levels were examined. The breakaway torque consistently correlated with an experienced surgeon's quantified impression of resistance as well as with vBMD of the same vertebra. Beyond a marginal prolongation of surgery time, no adverse events related to the usage of the device were observed. CONCLUSIONS: The intraoperative transpedicular measurement of the peak breakaway torque was technically feasible, safe, and reliably predictive of local vBMD during dorsal spinal instrumentations in a clinical setting. Larger studies are needed to define specific thresholds that indicate a need for the augmentation or instrumentation of additional levels.

The use of Reamer Irrigator Aspirator (RIA) autograft harvest in the treatment of critical-sized iliac wing defects in sheep: investigation of dexamethasone and beta-tricalcium phosphate augmentation.

Bone grafts are commonly used for the treatment of segmental bone defects and fracture non-unions. Recently, osseous particles obtained during intermedullary canal reaming (using a Reamer-Irrigator-Aspirator (RIA) device) have been evaluated as graft material during in vitro and clinical studies. The aim of this study was to evaluate and quantify new bone formation after implantation of bone graft material obtained after reaming of the tibia in a bilateral critical-sized iliac wing defect in sheep and to investigate the effect of the augmentation of this graft. A reamer bone graft alone, or after short term incubation in a dexamethasone enriched solution, and a reamer graft collected using beta-tricalcium phosphate (ß-TCP) granules in the filter of the RIA collection device were compared to autologous iliac wing graft. In addition, reamer graft was combined with the cellular fraction collected from the irrigation fluid with and without short-term incubation in a dexamethasone enriched solution. It was hypothesized that the amount of physical bone in the reamer bone graft groups would be higher than the amount in the autologous iliac wing graft group and that augmentation of a reamer bone graft would increase bone formation. Three months after implantation, the amount of new bone formation (as percentage of the total defect volume) in the defects was evaluated ex-vivo by means of micro-CT and histomorphometry. The mean amount of bone in the autologous iliac wing graft group was 17.7% and 16.8% for micro-CT and histomorphometry, respectively. The mean amount of bone in all reamer graft groups ranged between 20.4-29.2% (micro-CT) and 17.0-25.4% (histomorphometry). Reamer graft collected using ß-TCP granules (29.2±1.7%) in the filter produced a significantly higher amount of bone in comparison to an autologous iliac wing graft evaluated by micro-CT. RIA bone grafts added a small increase in bone volume to the 3month graft volume in this preclinical sheep model. The current model does not support the use of short-term high concentration dexamethasone for augmentation of a graft volume. If avoidance of an iliac wing graft is desirable, or a reaming procedure is required, then a RIA graft or RIA graft plus ß-TCP granules are as good as the current gold standard for this model.

The transpedicular approach as an alternative route for intervertebral disc regeneration.

STUDY DESIGN: Descriptive anatomical study on ovine and human cadaveric lumbar spinal segments. OBJECTIVE: To describe the alternative transpedicular approach to deliver therapeutic agents into intervertebral disc (IVD). SUMMARY OF BACKGROUND DATA: The present delivery approach of therapeutic agents (growth factors/cells/hydrogels) within the IVD is through injection, via the annulus fibrosus (AF). However, it has recently been demonstrated that small needle puncture of the AF leads to further degeneration and disc herniation. In addition, the injected material has a high chance to be extruded through the AF injury. METHODS: Lumbar ovine and human spinal segments were used. Under fluoroscopy, a 2-mm Kirschner wire was introduced in the caudal vertebra through the pedicle and the inferior endplate to the nucleus pulposus. Gross anatomy analysis and high-resolution peripheral quantitative computed tomography (HR-pQCT) were performed to assess the right position of the wire in pedicles. Discography and nucleotomy were performed using a 14G cannula insertion or a 2-mm arthroscopic shaver blade, respectively. Nucleoplasty was also performed with agarose gel/contrast agent and imaged with HR-pQCT. RESULTS: Gross anatomy, fluoroscopy, and HR-pQCT images showed that the nucleus pulposus could be approached through the endplate via the pedicle without affecting the spinal canal and the neural foramina. The contrast agent was delivered into the IVD and nucleus pulposus was removed from the disc and filled with agarose gel. CONCLUSION: This study describes how a transpedicular approach can be used as an alternative route to deliver therapeutic agents to the disc without disruption of the AF showing the potential use of this technique in preclinical research and highlighting its clinical relevance for IVD regeneration.

Influence of peri-implant bone quality on implant stability.

INTRODUCTION: Insufficient primary stability is still reported for proximal humerus fractures in elderly patients. Fixation stability could be improved by aiming locking screws at bone volumes with better properties. The aims of this study were to investigate the bone regions engaged by the locking screws of a Proximal Humeral Nail (MultiLoc PHN), and to evaluate the influence of peri-screw bone quality on bone-nail construct stability. MATERIALS AND METHODS: Twelve cadaveric humeri were divided into two groups. The distal locking part of the PHN was fixed to the specimens. The nails were removed and the bones scanned using HR-pQCT. Bone properties were evaluated at the locations where the proximal locking screws would have been positioned after complete instrumentation. A three-part fracture model was used for mechanical testing of the instrumented bones, considering axial displacement and varus deformation as parameters of interest. RESULTS: The secondary locking screws targeted bone volumes in the posteromedial part of the humerus with statistically significant higher quality, thus reducing varus deformation. Significant correlation was found between axial displacement and bone properties at the primary proximal screws. Significant correlation was found between the varus deformation and apparent BMD at the secondary locking screws. CONCLUSION: The findings of this study confirmed that directing the proximal locking screws at bone regions with better properties can improve fixation stability.

Biomechanical evaluation of two intramedullary nailing techniques with different locking options in a three-part fracture proximal humerus model.

BACKGROUND: Osteosynthesis of unstable proximal humerus fractures still remains challenging. The aim of this study was to investigate two intramedullary nailing techniques with different locking options in a three-part fracture model and prove whether two new fixation concepts, introducing additional locking screw-in-screws inserted through the head of the proximal screws, and a calcar screw, provide better stability. METHODS: A biomechanical testing model for three-part proximal humerus fractures including cyclic axial loading with increasing peak load and simultaneous pulling forces at the rotator cuff was used to test 12 pairs of human cadaver humeri, assigned to four groups and instrumented with either Targon PH (T1) or MultiLoc PHN in 3 different configurations (standard M1; two additional screw-in-screw M2; one additional calcar screw and two screw-in-screw M3). FINDINGS: Initial range of motion in internal-external rotation and mediolateral translation was smallest in M3 (1.82°; 0.11mm), biggest in T1 (3.63°; 0.51mm) and significantly different between these two groups (p=0.02 and p=0.04, respectively). M3 showed minimum head migration along the nail and varus tilting after 5000 cycles (0.31mm; 0.20°) and 10000 cycles (1.59mm; 0.34°). M2 and M3 performed better than M1 and T1 regarding varus collapse. The highest number of cycles to failure was observed for M3 (20733) and the lowest for T1 (10083) with significant difference between these two groups (p=0.04). INTERPRETATION: The configuration with two screw-in-screw and a calcar screw was superior in most aspects. The screw-in-screws were found to contribute against varus collapse. Both new fixation concepts could provide better stability in proximal humerus fractures.

Prediction of bone strength at the distal tibia by HR-pQCT and DXA.

BACKGROUND: Areal bone mineral density (aBMD) at the distal tibia, measured at the epiphysis (T-EPI) and diaphysis (T-DIA), is predictive for fracture risk. Structural bone parameters evaluated at the distal tibia by high resolution peripheral quantitative computed tomography (HR-pQCT) displayed differences between healthy and fracture patients. With its simple geometry, T-DIA may allow investigating the correlation between bone structural parameter and bone strength. METHODS: Anatomical tibiae were examined ex vivo by DXA (aBMD) and HR-pQCT (volumetric BMD (vBMD) and bone microstructural parameters). Cortical thickness (CTh) and polar moment of inertia (pMOI) were derived from DXA measurements. Finally, an index combining material (BMD) and mechanical property (polar moment of inertia, pMOI) was defined and analyzed for correlation with torque at failure and stiffness values obtained by biomechanical testing. RESULTS: Areal BMD predicted the vBMD at T-EPI and T-DIA. A high correlation was found between aBMD and microstructural parameters at T-EPIas well as between aBMD and CTh at T-DIA. Finally, at T-DIA both indexes combining BMD and pMOI were strongly and comparably correlated with torque at failure and bone stiffness. CONCLUSION: Ex vivo, at the distal tibial diaphysis, a novel index combining BMD and pMOI, which can be calculated directly from a single DXA measurement, predicted bone strength and stiffness better than either parameter alone and with an order of magnitude comparable to that of HR-pQCT. Whether this index is suitable for better prediction of fracture risk in vivo deserves further investigation.

Where do locking screws purchase in the humeral head?

INTRODUCTION: One of the limiting factors in finding the best osteosynthesis approach in proximal humerus fractures is the current lack of information on the properties of the cancellous bone regions engaged by the implants fixing the epiphysis. The aim of this study is to assess the densitometric and mechanical characteristics of these regions when using a proximal humerus locking plate (PHLP). MATERIALS AND METHODS: Nineteen PHLPs were mounted on cadaveric humeri using only their three most distal screws. Subsequently, the plates were removed and the bones were scanned using high-resolution peripheral quantitative computed tomography. Bone mineral density (BMD) was determined in the intact proximal epiphysis and in the exact locations where the six proximal screws would have been positioned concluding the instrumentation. Each plate was then repositioned on its bone and a minimally destructive local torque measurement was performed in the same six locations. A statistical analysis was performed to detect significant differences in the investigated parameters between screw positions, and to test the ability of local torque values to discriminate the bone mineral density of the entire humeral head (BMD(TOT)). RESULTS: Novel data about the cancellous bone engaged by the screws of a PHLP are provided. Different epiphyseal locations showed statistically significant different properties. A local torque measurement was a good predictor of the BMD(TOT). CONCLUSION: Position and direction of the epiphyseal screws on a locking implant are determinant to engage bone regions with significantly better bone quality. A breakaway torque measurement in a given screw position can distinguish between humeral heads with different densitometric properties.

Does cancellous bone compaction due to insertion of a blade implant influence the cut-out resistance? A biomechanical study.

BACKGROUND: For the treatment of hip fractures helically shaped implants, like the Dynamic Hip Screw (DHS) Blade, are often used. One consequence of blade implantation, the compaction of cancellous bone, is still believed to increase cut-out resistance. This in vitro study investigates implant anchorage of Dynamic Hip Screw Blades in femoral heads due to insertion with or without predrilling under cyclic physiological loading conditions. METHODS: Six pairs of fresh frozen (-20°C) human cadaveric proximal femora were instrumented with DHS Blades. Bone pairs were randomly assigned to two study groups: 1) predrilled; 2) non-predrilled. Prior instrumentation, bone mineral density was determined in the center of the femoral head by Xtreme-CT measurement. After instrumentation biomechanical testing was performed under cyclic loading. The bone-implant interface was monitored by means of fluoroscopic imaging throughout the experiment. Paired t-tests were performed to identify differences regarding bone mineral density, stiffness and cycles to failure. FINDINGS: No significant differences were found between study groups with regard to axial stiffness (P=0.626) and number of cycles to failure (P=0.961). INTERPRETATION: This in vitro study did not show differences in biomechanical stability of proximal femora instrumented with a helical blade implant with or without predrilling. Clinically, the findings suggest that predrilling may be performed to ease the surgical procedure without compromising the implant anchorage.