Biomechanical properties and thermal characteristics of frozen versus thawed whole bone.

Biomechanics research often requires cadaveric whole bones to be stored in a freezer and then thawed prior to use; however, the literature shows a variety of practices for thawing. Consequently, this is the first study to report the mechanical properties of fully frozen versus fully thawed whole bone as 'proof of principle'. Two groups of 10 porcine ribs each were statistically equivalent at baseline in length, cross-sectional area, and bone mineral density. The two groups were stored in a freezer for at least 24 h, thawed in air at 23 °C for 4 h while temperature readings were taken to establish the time needed for thawing, and once again returned to the freezer for at least 24 h. Mechanical tests to failure using three-point bending were then done on the 'frozen' group immediately after removal from the freezer and the 'thawed' group when steady-state ambient air temperature was reached. Temperature readings over the entire thawing period were described by the line-of-best-fit formula T = (28.34t - 6.69)/(t + 0.38), where T = temperature in degree Celsius and t = time in hours, such that frozen specimens at t = 0 h had a temperature of -17 °C and thawed specimens at t = 1.75 h reached a steady-state temperature of 20 °C-23 °C. Mechanical tests showed that frozen versus thawed specimens had an average of 32% higher stiffness k, 34% higher ultimate force Fu, 28% lower ultimate displacement δu, 40% lower ultimate work Wu, 43% higher elastic modulus E, 37% higher ultimate normal stress σu, and 33% higher ultimate shear stress τu. Whole ribs failed at midspan primarily by transverse cracking (16 of 20 cases), oblique cracking (three of 20 cases), or surface denting (one of 20 cases), each having unique shapes for force versus displacement graphs differentiated mainly by ultimate force location.

Experimental Validation of the Radiographic Union Score for Tibial Fractures (RUST) Using Micro-Computed Tomography Scanning and Biomechanical Testing in an in-Vivo Rat Model.

BACKGROUND: The Radiographic Union Score for Tibial fractures (RUST) and the modified version of the system, mRUST, are popular standards for assessing fracture-healing progress with use of radiographs. To our knowledge, this is the first study to experimentally validate the ability of RUST and mRUST to accurately assess bone-healing progression with use of both micro-computed tomography (micro-CT) scanning and biomechanical testing. METHODS: Adult male rats (n = 29) underwent osteotomy with a midshaft fracture gap repaired with use of a polyetheretherketone plate. Anteroposterior and lateral radiographs were made of the repaired femora prior to rat death at end points of 5, 6, 7, 8, 9, and 17 weeks, and 2 fellowship-trained orthopaedic trauma surgeons independently assigned RUST and mRUST scores to repaired femora. The repaired and intact contralateral femora were then dissected. Bones underwent dissection, micro-CT scanning, and biomechanical torsion testing at the end points. RESULTS: RUST scores ranged from 5 to 12 and mRUST scores ranged from 5 to 16. Intraclass correlation coefficients (ICCs) were 0.89 (95% confidence interval [CI]: 0.78 to 0.94) for RUST and 0.86 (95% CI: 0.74 to 0.93) for mRUST, which fall within the "almost perfect agreement" category for ICCs. Spearman rank correlation coefficients (RS) showed correlation of RUST (RS range, 0.456 to 0.818) and mRUST (RS range, 0.519 to 0.862) with micro-CT measurements of mineralized callus volume (BV), total callus volume (TV), and BV/TV ratio, but less so with bone mineral density (BMD). Additionally, RUST (RS range, 0.524 to 0.863) and mRUST (RS range, 0.434 to 0.850) were correlated with some biomechanical properties. A RUST score of 10 or an mRUST score of 15 may be considered the threshold above which a plated bone is "healed" because, at these scores, 120% or 140% of failure torque, respectively, was achieved by the repaired femora as compared with the intact contralateral femora. CONCLUSIONS: RUST and mRUST both show strong statistical correlations with micro-CT and biomechanical parameters. CLINICAL RELEVANCE: RUST and mRUST scoring systems provide clinicians with validated, reliable, and available tools to assess the progress of fracture-healing.

Biomechanical Testing of a 3-Hole Versus a 4-Hole Sliding Hip Screw in the Presence of a Retrograde Intramedullary Nail for Ipsilateral Intertrochanteric and Femur Shaft Fractures.

OBJECTIVE: The goal of this study was to compare a 3-hole versus a 4-hole sliding hip screw (SHS) in the presence of a retrograde intramedullary (RIM) nail for fixing intertrochanteric and comminuted midshaft femur fractures. METHODS: Mechanical tests were performed on 10 matched pairs of human cadaveric femurs that were osteotomized and then fixed using a 3-hole SHS versus the traditional "gold standard" 4-hole SHS in the presence of an RIM nail. RESULTS: Data showed no differences between the 3-hole SHS with RIM nail versus 4-hole SHS with RIM nail for stiffness (281 ± 127 vs. 260 ± 118 N/mm, P = 0.76), clinical failure at 10 mm of hip displacement (2014 ± 363 vs. 2134 ± 614 N, P = 0.52), or ultimate mechanical failure (3476 ± 776 vs. 3669 ± 755 N, P = 0.12). CONCLUSIONS: For this fracture pattern, a 3-hole SHS with RIM nail may be a suitable surgical alternative to the traditional "gold standard" method because it provides the same biomechanical properties while potentially reducing surgical time, blood loss, and hardware used.

Estimating the density of femoral head trabecular bone from hip fracture patients using computed tomography scan data.

The purpose of this study was to compare computed tomography density (ρCT ) obtained using typical clinical computed tomography scan parameters to ash density (ρash ), for the prediction of densities of femoral head trabecular bone from hip fracture patients. An experimental study was conducted to investigate the relationships between ρash and ρCT and between each of these densities and ρbulk and ρdry . Seven human femoral heads from hip fracture patients were computed tomography-scanned ex vivo, and 76 cylindrical trabecular bone specimens were collected. Computed tomography density was computed from computed tomography images by using a calibration Hounsfield units-based equation, whereas ρbulk, ρdry and ρash were determined experimentally. A large variation was found in the mean Hounsfield units of the bone cores (HUcore) with a constant bias from ρCT to ρash of 42.5 mg/cm3. Computed tomography and ash densities were linearly correlated (R 2 = 0.55, p < 0.001). It was demonstrated that ρash provided a good estimate of ρbulk (R 2 = 0.78, p < 0.001) and is a strong predictor of ρdry (R 2 = 0.99, p < 0.001). In addition, the ρCT was linearly related to ρbulk (R 2 = 0.43, p < 0.001) and ρdry (R 2 = 0.56, p < 0.001). In conclusion, mineral density was an appropriate predictor of ρbulk and ρdry , and ρCT was not a surrogate for ρash . There were linear relationships between ρCT and physical densities; however, following the experimental protocols of this study to determine ρCT , considerable scatter was present in the ρCT relationships.

3D atlas-based registration can calculate malalignment of femoral shaft fractures in six degrees of freedom.

OBJECTIVE: This study presents and evaluates a semi-automated algorithm for quantifying malalignment in complex femoral shaft fractures from a single intraoperative cone-beam CT (CBCT) image of the fractured limb. METHODS: CBCT images were acquired of complex comminuted diaphyseal fractures created in 9 cadaveric femora (27 cases). Scans were segmented using intensity-based thresholding, yielding image stacks of the proximal, distal and comminuted bone. Semi-deformable and rigid affine registrations to an intact femur atlas (synthetic or cadaveric-based) were performed to transform the distal fragment to its neutral alignment. Leg length was calculated from the volume of bone within the comminution fragment. The transformations were compared to the physical input malalignments. RESULTS: Using the synthetic atlas, translations were within 1.71 ± 1.08 mm (medial/lateral) and 2.24 ± 2.11 mm (anterior/posterior). The varus/valgus, flexion/extension and periaxial rotation errors were 3.45 ± 2.6°, 1.86 ± 1.5° and 3.4 ± 2.0°, respectively. The cadaveric-based atlas yielded similar results in medial/lateral and anterior/posterior translation (1.73 ± 1.28 mm and 2.15 ± 2.13 mm, respectively). Varus/valgus, flexion/extension and periaxial rotation errors were 2.3 ± 1.3°, 2.0 ± 1.6° and 3.4 ± 2.0°, respectively. Leg length errors were 1.41 ± 1.01 mm (synthetic) and 1.26 ± 0.94 mm (cadaveric). The cadaveric model demonstrated a small improvement in flexion/extension and the synthetic atlas performed slightly faster (6 min 24 s ± 50 s versus 8 min 42 s ± 2 min 25 s). CONCLUSIONS: This atlas-based algorithm quantified malalignment in complex femoral shaft fractures within clinical tolerances from a single CBCT image of the fractured limb.

Biomechanical measurements of stopping and stripping torques during screw insertion in five types of human and artificial humeri.

During orthopedic surgery, screws are inserted by "subjective feel" in humeri for fracture fixation, that is, stopping torque, while trying to prevent accidental over-tightening that causes screw-bone interface failure, that is, stripping torque. However, no studies exist on stopping torque, stripping torque, or stopping/stripping torque ratio in human or artificial humeri. This study evaluated five types of humeri, namely, human fresh-frozen (n = 19), human embalmed (n = 18), human dried (n = 15), artificial "normal" (n = 13), and artificial "osteoporotic" (n = 13). An orthopedic surgeon used a torque screwdriver to insert 3.5-mm-diameter cortical screws into humeral shafts and 6.5-mm-diameter cancellous screws into humeral heads by "subjective feel" to obtain stopping and stripping torques. The five outcome measures were raw and normalized stopping torque, raw and normalized stripping torque, and stopping/stripping torque ratio. Normalization was done as raw torque/screw-bone interface area. For "gold standard" fresh-frozen humeri, cortical screw tests yielded averages of 1312 N mm (raw stopping torque), 30.4 N/mm (normalized stopping torque), 1721 N mm (raw stripping torque), 39.0 N/mm (normalized stripping torque), and 82% (stopping/stripping torque ratio). Similarly, fresh-frozen humeri gave cancellous screw average results of 307 N mm (raw stopping torque), 0.9 N/mm (normalized stopping torque), 392 N mm (raw stripping torque), 1.2 N/mm (normalized stripping torque), and 79% (stopping/stripping torque ratio). Of the five cortical screw parameters for fresh-frozen humeri versus other groups, statistical equivalence (p ≥ 0.05) occurred in four cases (embalmed), three cases (dried), four cases (artificial "normal"), and four cases (artificial "osteoporotic"). Of the five cancellous screw parameters for fresh-frozen humeri versus other groups, statistical equivalence (p ≥ 0.05) occurred in five cases (embalmed), one case (dried), one case (artificial "normal"), and zero cases (artificial "osteoporotic"). Stopping/stripping torque ratios were relatively constant for all groups at 77%-88% (cortical screws) and 79%-92% (cancellous screws).

Biomechanical measurements of stiffness and strength for five types of whole human and artificial humeri.

The human humerus is the third largest longbone and experiences 2-3% of all fractures. Yet, almost no data exist on its intact biomechanical properties, thus preventing researchers from obtaining a full understanding of humerus behavior during injury and after being repaired with fracture plates and nails. The aim of this experimental study was to compare the biomechanical stiffness and strength of "gold standard" fresh-frozen humeri to a variety of humerus models. A series of five types of intact whole humeri were obtained: human fresh-frozen (n = 19); human embalmed (n = 18); human dried (n = 15); artificial "normal" (n = 12); and artificial "osteoporotic" (n = 12). Humeri were tested under "real world" clinical loading modes for shear stiffness, torsional stiffness, cantilever bending stiffness, and cantilever bending strength. After removing geometric effects, fresh-frozen results were 585.8 ± 181.5 N/mm2 (normalized shear stiffness); 3.1 ± 1.1 N/(mm2 deg) (normalized torsional stiffness); 850.8 ± 347.9 N/mm2 (normalized cantilever stiffness); and 8.3 ± 2.7 N/mm2 (normalized cantilever strength). Compared to fresh-frozen values, statistical equivalence (p ≥ 0.05) was obtained for all four test modes (embalmed humeri), 1 of 4 test modes (dried humeri), 1 of 4 test modes (artificial "normal" humeri), and 1 of 4 test modes (artificial "osteoporotic" humeri). Age and bone mineral density versus experimental results had Pearson linear correlations ranging from R = -0.57 to 0.80. About 77% of human humeri failed via a transverse or oblique distal shaft fracture, whilst 88% of artificial humeri failed with a mixed transverse + oblique fracture. To date, this is the most comprehensive study on the biomechanics of intact human and artificial humeri and can assist researchers to choose an alternate humerus model that can substitute for fresh-frozen humeri.

Can fluoroscopy-based computer navigation improve entry point selection for intramedullary nailing of femur fractures?

BACKGROUND: The entry point is crucial to an accurate reduction in femoral nailing. Fluoroscopy-based navigation was developed to aid in reducing femur fractures and selecting entry points. QUESTIONS/PURPOSES: We asked: (1) Can the piriformis fossa (PF) and tip of the greater trochanter (TT) be identified with high reproducibility? (2) What is the range of nonneutral images clinically acceptable for entry point selection? (3) Does navigation improve accuracy and precision of landmarking the TT and PF? And (4) does off-angle fluoroscopy within the acceptable range affect landmark accuracy? METHODS: Three orthopaedic surgeons digitized the PF and TT under direct visualization on 10 cadaveric femurs, quantifying the reproducibility of the targeted PF and TT landmarks. Arcs of acceptable AP and lateral images of each femur were acquired in increments of 5° with a C-arm. An experienced orthopaedic surgeon rejected or accepted images for entry point selection by qualitatively assessing the relative positions and sizes of the greater trochanter, lesser trochanter, and femoral neck. Entry points were identified on each image using fluoroscopy and navigation. Hierarchical linear modeling was used to compare accuracy and precision between navigation and fluoroscopy and the effects of image angle. RESULTS: A 29° average arc of acceptable images was found. Reproducibility of the target landmarks for the PF and TT under direct visualization was excellent. Navigation had similar accuracy to fluoroscopy for PF localization but less for TT. Navigation increased precision compared to fluoroscopy for both PF and TT. Image angle affected accuracy of the PF and TT under fluoroscopy and navigation. CONCLUSIONS: Nonorthogonal images reduce accuracy of PF and TT identification with both navigation and fluoroscopy. Navigation increased precision but decreased accuracy and cannot overcome inaccuracies induced by nonorthogonal images.

Biomechanical measurements of cortical screw purchase in five types of human and artificial humeri.

Humerus shaft fracture fixation is largely dependent on cortical screw purchase in host bone. Only 2 prior studies assessed cortical screw purchase in human humeral shafts, but were of very limited scope and did not fully assess humerus material properties. Also, no studies evaluated the human dried or artificial humeri both commercially available from Sawbones. Vashon, WA, USA. Therefore, present authors measured cortical screw purchase in human fresh-frozen (FF) (n=19), human embalmed (EM) (n=18), human dried (DR) (n=14), artificial "normal" (AN) (n=13), and artificial "osteoporotic" (AO) (n=13) humeri. Each humerus had 2 bicortical screws of 3.5-mm diameter inserted 20mm apart through the shaft's anterior and posterior cortices. Absolute force, displacement, and energy for screw-bone interface failure were measured by screw pullout tests, afterwhich data were normalized by total surface area engaged at the screw-bone interface. For absolute force, AN humeri reached a higher load than EM (p=0.001) and AO (p<0.001) humeri, whilst AN humeri achieved lower normalized force than DR humeri (p=0.018). For absolute displacement, AO humeri achieved a lower level than FF humeri (p=0.013), whilst for normalized displacement AN humeri had lower levels than all other groups (p≤0.005) and AO humeri had lower values than EM humeri (p=0.029). For absolute and normalized energy, there were no statistical differences (p≥0.066). Human bone mineral density (BMD) ranged from 0.7 to 1.8g/cm(2) and was linearly correlated to screw pullout parameters in 14 of 18 cases (R=0.61 to 0.96), whilst humerus age was not. Consequently, it is recommended that human fresh-frozen, human embalmed, and human dried humeri can be used interchangeably for cortical screw purchase, since they were statistically equivalent for all comparisons. However, artificial humeri were involved in all statistical differences observed and, thus, may not replicate cortical screw purchase in human humeri. To date, this is the most comprehensive study on cortical screw purchase in human and artificial humeral shafts.

The biomechanical effect of artificial and human bone density on stopping and stripping torque during screw insertion.

Orthopedic surgeons apply torque to metal screws manually by "subjective feel" to obtain adequate fracture fixation, i.e. stopping torque, and attempt to avoid accidental over-tightening that leads to screw-bone interface failure, i.e. stripping torque. Few studies have quantified stripping torque in human bone, and only one older study from 1980 reported stopping/ stripping torque ratio. The present aim was to measure stopping and stripping torque of cortical and cancellous screws in artificial and human bone over a wide range of densities. Sawbone blocks were obtained having densities from 0.08 to 0.80g/cm(3). Sixteen fresh-frozen human femurs of known standardized bone mineral density (sBMD) were also used. Using a torque screwdriver, 3.5-mm diameter cortical screws and 6.5-mm diameter cancellous screws were inserted for adequate tightening as determined subjectively by an orthopedic surgeon, i.e. stopping torque, and then further tightened until failure of the screw-bone interface, i.e. stripping torque. There were weak (R=0.25) to strong (R=0.99) linear correlations of absolute and normalized torque vs. density or sBMD. Maximum stopping torques normalized by screw thread area engaged by the host material were 15.2N/mm (cortical screws) and 13.4N/mm (cancellous screws) in sawbone blocks and 20.9N/mm (cortical screws) and 6.1N/mm (cancellous screws) in human femurs. Maximum stripping torques normalized by screw thread area engaged by the host material were 23.4N/mm (cortical screws) and 16.8N/mm (cancellous screws) in sawbone blocks and 29.3N/mm (cortical screws) and 8.3N/mm (cancellous screws) in human femurs. Combined average stopping/ stripping torque ratios were 80.8% (cortical screws) and 76.8% (cancellous screws) in sawbone blocks, as well as 66.6% (cortical screws) and 84.5% (cancellous screws) in human femurs. Surgeons should be aware of stripping torque limits for human femurs and monitor stopping torque during surgery. This is the first study of the effect of sawbone density or human bone sBMD on stopping and stripping torque.

Can a semi-automated surface matching and principal axis-based algorithm accurately quantify femoral shaft fracture alignment in six degrees of freedom?

Accurate alignment of femoral shaft fractures treated with intramedullary nailing remains a challenge for orthopaedic surgeons. The aim of this study is to develop and validate a cone-beam CT-based, semi-automated algorithm to quantify the malalignment in six degrees of freedom (6DOF) using a surface matching and principal axes-based approach. Complex comminuted diaphyseal fractures were created in nine cadaveric femora and cone-beam CT images were acquired (27 cases total). Scans were cropped and segmented using intensity-based thresholding, producing superior, inferior and comminution volumes. Cylinders were fit to estimate the long axes of the superior and inferior fragments. The angle and distance between the two cylindrical axes were calculated to determine flexion/extension and varus/valgus angulation and medial/lateral and anterior/posterior translations, respectively. Both surfaces were unwrapped about the cylindrical axes. Three methods of matching the unwrapped surface for determination of periaxial rotation were compared based on minimizing the distance between features. The calculated corrections were compared to the input malalignment conditions. All 6DOF were calculated to within current clinical tolerances for all but two cases. This algorithm yielded accurate quantification of malalignment of femoral shaft fractures for fracture gaps up to 60 mm, based on a single CBCT image of the fractured limb.

Biomechanical measurements of cortical screw stripping torque in human versus artificial femurs.

Femur fracture plates are applied using cortical bone screws. Surgeons do this manually by subjective 'feel' without monitoring torque. Few studies have quantified stripping torque in human bone. No studies have measured stripping torque in the artificial bones from Sawbones (Vashon, WA, USA) that are frequently used in biomechanical studies. The present aim was to measure stripping torque of cortical screws in human versus artificial femurs. Sixteen fresh-frozen human femurs and eight artificial femurs were used. Using a digital torque screwdriver, each femur had a 3.5-mm diameter uni-cortical screw manually inserted into the anterior midshaft until failure of the screw-bone interface. Results were normalized by cortical thickness and the screw-bone interfacial area. There were no statistical differences in human versus artificial data, respectively, for stripping torque (1741 +/- 442 N.mm, 2012 +/- 176 N.mm, p = 0.11), stripping torque/thickness (313 +/- 59 N, 305 +/- 30 N, p = 0.74), and stripping torque area (28.5 +/- 5.3 N/mm, 27.8 +/- 2.8 N/mm, p = 0.74). Artificial unicortical thickness (6.6 + 0.3 mm) was greater than human thickness (5.6 +/- 1.1 mm) (p = 0.02). For human specimens, there was a moderate linear correlation of absolute and normalized stripping torque versus standardized bone mineral density (R > or = 0.32) and clinical T-score (R = 0.29), but not with age (R < or = 0.29). Surgeons should be aware of the stripping torque limits for human femurs and potentially take steps to monitor these values during surgery. The artificial femurs being increasingly used in research accurately replicate human cortical properties during screw insertion. To date, this is the first series of human femurs evaluated for cortical screw stripping.

Biomechanical measurements of axial crush injury to the distal condyles of human and synthetic femurs.

Few studies have evaluated the 'bulk' mechanical properties of human longbones and even fewer have compared human tissue to the synthetic longbones increasingly being used by researchers. Distal femur fractures, for example, comprise about 6% of all femur fractures, but the mechanical properties of the distal condyles of intact human and synthetic femurs have not been well quantified in the literature. To this end, the distal portions of a series of 16 human fresh-frozen femurs and six synthetic femurs were prepared identically for mechanical testing. Using a flat metal plate, an axial 'crush' force was applied in-line with the long axis of the femurs. The two femur groups were statistically compared and values correlated to age, size, and bone quality. Results yielded the following: crush stiffness (human, 1545 +/- 728 N/mm; synthetic, 3063 +/- 1243 N/mm; p = 0.002); crush strength (human, 10.3 +/- 3.1 kN; synthetic, 12.9 < or = 1.7 kN; p = 0.074); crush displacement (human, 6.1 +/- 1.8 mm; synthetic, 2.8 +/- 0.3 mm; p = 0.000); and crush energy (human, 34.8 +/- 15.9J; synthetic, 18.1 +/- 5.7J; p = 0.023). For the human femurs, there were poor correlations between mechanical properties versus age, size, and bone quality (R2 < or = 0.18), with the exception of crush strength versus bone mineral density (R2 = 0.33) and T-score (R2 = 0.25). Human femurs failed mostly by condyle 'roll back' buckling (15 of 16 cases) and/or unicondylar or bicondylar fracture (7 of 16 cases), while synthetic femurs all failed by wedging apart of the condyles resulting in either fully or partially displaced condylar fractures (6 of 6 cases). These findings have practical implications on the use of a flat plate load applicator to reproduce real-life clinical failure modes of human femurs and the appropriate use of synthetic femurs. To the authors' knowledge, this is the first study to have done such an assessment on human and synthetic femurs.

Computer navigation in the reduction and fixation of femoral shaft fractures: a randomized control study.

OBJECTIVES: We investigated the accuracy of reduction of intramedullary nailed femoral shaft fractures in human cadavers, comparing conventional and computer navigation techniques. METHODS: Twenty femoral shaft fractures were created in human cadavers, with segmental defects ranging from 9 to 53 mm in length (Winquist 3-4, AO 32C2). All fractures were fixed with antegrade 9 mm diameter femoral nails on a radiolucent operating table. Five fractures ("Fluoro" group) were fixed with conventional techniques and fifteen fractures ("Nav 1" and "Nav 2" groups) with computer navigation, using fluoroscopic images of the normal femur to correct for length and rotation. Postoperative CT scans compared femoral length and rotation with the normal leg. RESULTS: Mean leg length discrepancy in the computer navigation groups was smaller, namely, 3.6 mm for Nav 1 (95% CI: 1.072 to 6.128) and 4.2 mm for Nav 2 (95% CI: 0.63 to 7.75) vs. 9.8 mm for Fluoro (95% CI: 6.225 to 13.37) (p<0.023). Mean rotational discrepancies were 8.7° for Nav 1 (95% CI: 4.282 to 13.12) and 5.6° for Nav 2 (95% CI: -0.65 to 11.85) vs. 9.0° for Fluoro (95% CI: 2.752 to 15.25) (p=0.650). CONCLUSIONS: Computer navigation significantly improves the accuracy of femoral shaft fracture fixation with regard to leg length, but not rotational deformity.

Biomechanical measurements of surgical drilling force and torque in human versus artificial femurs.

Few experimental studies have examined surgical drilling in human bone, and no studies have inquired into this aspect for a popular commercially-available artificial bone used in biomechanical studies. Sixteen fresh-frozen human femurs and five artificial femurs were obtained. Cortical specimens were mounted into a clamping system equipped with a thrust force and torque transducer. Using a CNC machine, unicortical holes were drilled in each specimen at 1000 rpm, 1250 rpm, and 1500 rpm with a 3.2 mm diameter surgical drill bit. Feed rate was 120 mm/min. Statistical significance was set at p < 0.05. Force at increasing spindle speed (1000 rpm, 1250 rpm, and 1500 rpm), respectively, showed a range for human femurs (198.4 ± 14.2 N, 180.6 ± 14.0 N, and 176.3 ± 11.2 N) and artificial femurs (87.2 ± 19.3 N, 82.2 ± 11.2 N, and 75.7 ± 8.8 N). For human femurs, force at 1000 rpm was greater than at other speeds (p ≤ 0.018). For artificial femurs, there was no speed effect on force (p ≥ 0.991). Torque at increasing spindle speed (1000 rpm, 1250 rpm, and 1500 rpm), respectively, showed a range for human femurs (186.3 ± 16.9 N·mm, 157.8 ± 16.1 N·mm, and 140.2 ± 16.4 N·mm) and artificial femurs (67.2 ± 8.4 N·mm, 61.0 ± 2.9 N·mm, and 53.3 ± 2.9 N·mm). For human femurs, torque at 1000 rpm was greater than at other speeds (p < 0.001). For artificial femurs, there was no difference in torque for 1000 rpm versus higher speeds (p ≥ 0.228), and there was only a borderline difference between the higher speeds (p = 0.046). Concerning human versus artificial femurs, their behavior was different at every speed (force, p ≤ 0.001; torque, p < 0.001). For human specimens at 1500 rpm, force and torque were linearly correlated with standardized bone mineral density (sBMD) and the T-score used to clinically categorize bone quality (R ≥ 0.56), but there was poor correlation with age at all speeds (R ≤ 0.37). These artificial bones fail to replicate force and torque in human cortical bone during surgical drilling. To date, this is the largest series of human long bones biomechanically tested for surgical drilling.

High-viscosity cement significantly enhances uniformity of cement filling in vertebroplasty: an experimental model and study on cement leakage.

STUDY DESIGN: Experimental study using a laboratory leakage model. OBJECTIVE: To examine the working hypothesis that high-viscosity cements will spread uniformly, thus significantly reducing the risk of leakage. SUMMARY OF BACKGROUND DATA: In vertebroplasty, forces that govern the flow of bone cement in the trabecular bone skeleton are an essential determinant of the uniformity of cement filling. Extraosseous cement leakage has been reported to be a major complication of this procedure. Leakage occurs due to the presence of a path of least resistance caused by irregularities in the trabecular bone or shell structure. Ideally, cement uniformly infiltrates the trabecular bone skeleton and does not favor specific paths. Cement viscosity is believed to affect the infiltration forces and flow during the procedure. Clinically, altering the time between cement mixing and delivery modifies the viscosity of bone cement. METHODS: An experimental model of the leakage phenomenon of vertebroplasty was developed. A path, simulating a blood vessel, was created in the model to perturb the forces underlying cement flow and to favor leakage. Cement of varying viscosities was injected in the model, and, thereafter, the filling pattern, cement mass that has leaked, time at which leakage occurred, and injection pressure were measured. RESULTS: A strong relationship was found between the uniformity of the filling pattern and the elapsed time from cement mixing and viscosity, respectively. Specifically, 3 distinct cement leakage patterns were observed: immediate leakage was observed when cement was injected 5-7 minutes following mixing. The cement was of a low viscosity and more than 50% of the total cement injected leaked. Moderate leakage was observed when injection occurred 7-10 minutes following mixing. Less than 10% of the cement leaked, and the viscosity was at a transient state between the low viscosity of immediate leakage and a higher viscosity, doughy cement. Cement leakage ceased completely when cement was delivered after 10 minutes. The viscosity of the cement in this case was high, and the cement was of a dough-like consistency. CONCLUSIONS: High-viscosity cement seems to stabilize cement flow. However, the forces required for the delivery of high-viscosity cement may approach or exceed the human physical limit of injection forces. Although the working time of the cement is about 17 minutes, it may not be manually injectable with a standard syringe and cannula after 10 minutes, at which time cement leakage ceased completely.