Damiano Schiuma

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.

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.

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.

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.

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.

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.

Development of a novel method for surgical implant design optimization through noninvasive assessment of local bone properties.

A method was developed to improve the design of locking implants by finding the optimal paths for the anchoring elements, based on a high resolution pQCT assessment of local bone mineral density (BMD) distribution and bone micro-architecture (BMA). The method consists of three steps: (1) partial fixation of the implant to the bone and creation of a reference system, (2) implant removal and pQCT scan of the bone, and (3) determination of BMD and BMA of all implant-anchoring locations along the actual and alternative directions. Using a PHILOS plate, the method uncertainty was tested on an artificial humerus bone model. A cadaveric humerus was used to quantify how the uncertainty of the method affects the assessment of bone parameters. BMD and BMA were determined along four possible alternative screw paths as possible criteria for implant optimization. The method is biased by a 0.87 ± 0.12 mm systematic uncertainty and by a 0.44 ± 0.09 mm random uncertainty in locating the virtual screw position. This study shows that this method can be used to find alternative directions for the anchoring elements, which may possess better bone properties. This modification will thus produce an optimized implant design.

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 patients 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 surgeons 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 (β-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 β-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 β-TCP granules are as good as the current gold standard for this model.