Continuous Implant Load Monitoring to Assess Bone Healing Status-Evidence from Animal Testing.

Background and Objectives: Fracture healing is currently assessed through qualitative evaluation of radiographic images, which is highly subjective in nature. Radiographs can only provide snapshots in time, which are limited due to logistics and radiation exposure. We recently proposed assessing the bone healing status through continuous monitoring of the implant load, utilizing an implanted sensor system, the Fracture Monitor. The device telemetrically transmits statistically derived implant parameters via the patient's mobile phone to assist physicians in diagnostics and treatment decision-making. This preclinical study aims to systematically investigate the device safety and performance in an animal setting. Materials and Methods: Mid-shaft tibial osteotomies of different sizes (0.6-30 mm) were created in eleven Swiss mountain sheep. The bones were stabilized with either a conventional Titanium or stainless-steel locking plate equipped with a Fracture Monitor. Data were continuously collected over the device's lifetime. Conventional radiographs and clinical CT scans were taken longitudinally over the study period. The radiographs were systematically scored and CTs were evaluated for normalized bone volume in the defect. The animals were euthanized after 9 months. The sensor output was correlated with the radiologic parameters. Tissue samples from the device location were histologically examined. Results: The sensors functioned autonomously for 6.5-8.4 months until energy depletion. No macroscopic or microscopic adverse effects from device implantation were observed. The relative implant loads at 4 and 8 weeks post-operation correlated significantly with the radiographic scores and with the normalized bone volume metric. Conclusions: Continuous implant load monitoring appears as a relevant approach to support and objectify fracture healing assessments and carries a strong potential to enable patient-tailored rehabilitation in the future.

Biphasic plating improves the mechanical performance of locked plating for distal femur fractures.

Internal fixation by plate osteosynthesis is the gold standard treatment for distal femur fractures. Despite improvements that preserve the biological conditions for bone healing, there are concerns standard locked plating constructs may be overly stiff. Biphasic plating is a novel concept designed to provide suitable fracture motion and increased implant strength to support early full weight-bearing. This study aims to demonstrate that the Biphasic Plate can be incorporated into a pre-contoured distal femur plate while providing adequate flexibility and increased implant strength. The mechanical performance of the Biphasic Plate (BP) was investigated in comparison to a standard locking plate for the distal femur (LCP-DF). Constructs were formed by mounting the implants on a bone substitute. The construct stiffness and strength under axial loading and the magnitude of interfragmentary movement were determined using finite element analysis. The Biphasic Plate exhibited a bi-linear stiffness response; at low loads, the BP construct was 55% more compliant and at high loads 476% stiffer than the LCP-DF. The Biphasic Plate provided more consistent interfragmentary movement over a wider loading range. At partial weight-bearing loads, the Biphasic Plate produced larger interfragmentary movements (0.18 vs. 0.04 mm). However, at loads equivalent to full weight-bearing, the maximum movements were substantially smaller than the LCP-DF construct (1.5 vs. 3.5 mm). The increased flexibility at low loads was provided without sacrificing implant strength with peak stress in the Biphasic Plate 63% lower than the LCP-DF construct. The biphasic plating concept can be successfully incorporated into anatomically contoured distal femur plates while providing adequate flexibility and increasing implant strength.

The relation between fracture activity and bone healing with special reference to the early healing phase - A preclinical study.

BACKGROUND: Fracture healing outcome is to a great extent steered by the mechanical environment. The importance of early phase mechanical fracture stimulation is still controversially discussed, both clinically and scientifically. Furthermore, the role of fracture activity, defined as the number of stimulatory events per time, is particularly for the direct postoperative phase unknown. METHODS: Tibial defects of seven Swiss mountain sheep were stabilized with a dynamizable bone fixator, which allowed for defined interfragmentary motion by limiting the maximum axial displacement. The fixator was further equipped with a telemetric measuring unit to continuously log all occurring displacement events above a predefined amplitude threshold over an 8-weeks observation period. Callus size was measured over time from X-rays. Ultimate torsional strength of the healed defects was assessed after euthanasia. RESULTS: One animal had to be excluded from the experiment due to technical reasons. The remaining six animals exhibited consistently the highest fracture activity in week 1 post-operation with 6'029 displacement events per week for the animal with the lowest activity and 21'866 events per week for the most active animal. Afterwards fracture activity gradually decreased over time. Strong and significant correlations were found for fracture activity in week 1 and 2 with torsional strength of the healed bone (R ≥ 0.881, p ≤ 0.02). No significant correlations were observed at later timepoints. Fracture activity in week 1 and 2 also correlated strongly with the maximum callus area as measured from X-rays (R ≥ 0.846, p ≤ 0.034). CONCLUSIONS: The data demonstrates a positive effect of, within limits, frequent fracture stimulation on bone healing and suggests the importance of the mechanical environment in the direct post-operative healing phase. Clinically, the findings may advocate for the concept of direct post-operative weight bearing. This, however, requires clinical validation and must be considered within the full clinical context including the risk for fixation failure from overloading.

Biphasic Plating - In vivo study of a novel fixation concept to enhance mechanobiological fracture healing.

BACKGROUND: Fracture fixation has advanced significantly with the introduction of locked plating and minimally invasive surgical techniques. However, healing complications occur in up to 10% of cases, of which a significant portion may be attributed to unfavorable mechanical conditions at the fracture. Moreover, state-of-the-art plates are prone to failure from excessive loading or fatigue. A novel biphasic plating concept has been developed to create reliable mechanical conditions for timely bone healing and simultaneously improve implant strength. This paper introduces the novel fixation concept and presents preclinical results from a large animal study. METHODS: Twenty-four sheep underwent a mid-diaphyseal osteotomy stabilized with either the novel biphasic plate fixator or a control locking plate. Different fracture patterns regarding orientation and localization were investigated. Animals were free to fully bear weight during the post-operative period. After 12 weeks, the healing fractures were evaluated for bone formation using micro-computer tomography and strength and stiffness using biomechanical testing. Additionally, histological evaluation of soft tissue samples with respect to metal wear debris was performed. RESULTS: No plate deformation or failures were observed under full weight bearing with the biphasic plate. Defects stabilized with the biphasic plate demonstrated robust callus formation compared to control group. Torsion tests after plate removal revealed no statistical difference in peak torsion to failure and stiffness for the different fracture patterns stabilized with the biphasic plate. However, the biphasic plate group specimens were 45% stronger (p=0.002) and 48% stiffer (p=0.007) than the controls. No histological signs of metal wear due to the biphasic feature could be found. CONCLUSIONS: The biphasic plate concept is aimed at improving the biomechanics of locked plating. The results of this large animal study demonstrate the feasibility and clinical potential of this novel stabilization concept.

Influence of reduced tip-apex distance on helical blade fixation-a biomechanical study.

Migration profile of helical blades differs from conventional screw design. Tip-apex distance (TAD) greater than 25 mm is associated with early failure in hip screws. This study investigates the effect of a reduced TAD on helical blade fixation. Six pairs of human femoral heads were used. Bone mineral density (BMD) was determined by pQCT. Local bone quality was evaluated by breakaway torque. Helical blades were implanted with TAD of 20 mm (normal) and 6 mm (reduced). Specimens were cyclically tested under progressively increasing physiologic loading at 2 Hz with starting peak force of 1'000N, increasing by 0.1N/cycle. Implant migration was monitored by radiographs every 250 cycles. Paired Student's t-test and Spearman rank correlation coefficient were used for statistical evaluation (p < 0.05). Mean BMD was 246.7 mgHA/cm3 SD48.7 (normal), 244.3 mgHA/cm3 SD47.6 (reduced); p = 0.93. Mean breakaway torque was 3.59 Nm SD2.11 (normal), 3.72 Nm SD1.83 (reduced); p = 0.91. Number of cycles to failure (1 mm vertical migration) was 16'416 SD7972 (normal), 20'000 SD5232 (reduced); p = 0.38. They correlated significantly with BMD (p = 0.01;R2 = 0.91) and breakaway torque (p < 0.049; R2 = 0.814) (normal). Breakaway torque correlated significantly with BMD (p = 0.02; R2 = 0.898) (normal). In reduced TAD these parameters did not correlate significantly. Normal TAD resulted in failure in varus collapse (n = 6), whereas reduced TAD showed blade perforation (n = 3), rotation (n = 2), varus collapse (n = 1). Fixation stability of helical blades correlates with bone quality when implants are fixed in cancellous bone. Near cortical blade fixation might increase the risk of intraarticular blade perforation. © 2018 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 9999:1-6, 2019.

Assessment of the Breakaway Torque at the Posterior Pelvic Ring in Human Cadavers.

PURPOSE: To enhance the diminished screw purchase in cancellous, osteoporotic bone following the fixation of posterior pelvic ring injuries by iliosacral screws an increased bone-implant contact area using modificated screws, techniques or bone cement may become necessary. The aim of the study was to identify sites within the pathway of iliosacral screws requiring modifications of the local bone or the design of instrumentations placed at this site. MATERIALS AND METHODS: The breakaway torque was measured mechanically at the iliosacral joint ("ISJ"), the sacral lateral mass ("SLM") and the center of the S1 ("CS1"), at a superior and an inferior site under fluoroscopic control on five human cadaveric specimens (3 female; mean age 87 years, range: 76-99) using the DensiProbe™Spine device. RESULTS: The measured median (range) breakaway torque was 0.63 Nm (0.31-2.52) at the "iliosacral joint", 0.14 Nm (0.05-1.22) at the "sacral lateral mass", 0.57 Nm (0.05-1.42) at the "S1 center." The "sacral lateral mass" breakaway torque was lower than compared to that at the "iliosacral joint" (p < .001) or "S1 center" (p < .001). The median (range) breakaway torque measured at all superior measurement points was 0.52 Nm (0.10-2.52), and 0.48 Nm (0.05-1.18) at all inferior sites. The observed difference was statistically significant (p < .05). CONCLUSIONS: The lateral mass of the sacrum provides the lowest bone quality for implant anchorage. Iliosacral screws should be placed as superior as safely possible, should bridge the iliosacral joint and may allow for cement application at the lateral mass of the sacrum through perforations.

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.

Mechanical quantification of local bone quality in the humeral head: a feasibility study.

OBJECTIVES: Surgical treatment of proximal humerus fractures can be challenging due to osteoporosis. The weak bone stock makes stable implant anchorage difficult, which can result in low primary stability. Accordingly, significant failure rates, even with modern locking plates, are reported in the literature. Intraoperative knowledge of local bone quality could be helpful in improving results. This study evaluates the feasibility of local bone quality quantification using breakaway torque measurements. MATERIALS AND METHODS: A torque measurement tool (DensiProbe™) was developed to determine local resistance to breakaway offered by the cancellous bone in the humeral head to quantify local bone quality. The tool was adapted to a standard locking plate (PHILOS, Synthes), allowing measurement in the positions of the six humeral head screws, as provided by the aiming device of the plate. Two hundred and seventy measurements were performed in 44 fresh cadaveric human humeri. RESULTS: Handling of the tool was straight forward and provided reproducible results for the six different positions. The method allows discrimination between the respective positions with statistical significance, and thus provides reliable information on the local distribution of bone quality within the humeral head. DISCUSSION: This study introduces a new method using breakaway torque to determine local bone quality within the humeral head in real time. Because DensiProbe is adapted to a standard locking plate, there is the potential for intraoperative application. The information provided could enable the surgeon to improve fixation of osteoporotic proximal humerus fractures.

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.

DensiProbe Spine: a novel instrument for intraoperative measurement of bone density in transpedicular screw fixation.

STUDY DESIGN: Cadaver study. OBJECTIVE: To determine bone strength in vertebrae by measuring peak breakaway torque or indentation force using custom-made pedicle probes. SUMMARY OF BACKGROUND DATA: Screw performance in dorsal spinal instrumentation is dependent on bone quality of the vertebral body. To date no intraoperative measuring device to validate bone strength is available. Destructive testing may predict bone strength in transpedicular instrumentations in osteoporotic vertebrae. Insertional torque measurements showed varying results. METHODS: Ten human cadaveric vertebrae were evaluated for bone mineral density (BMD) measurements by quantitative computed tomography. Peak torque and indentation force of custom-made probes as a measure for mechanical bone strength were assessed via a transpedicular approach. The results were correlated to regional BMD and to biomechanical load testing after pedicle screw implementation. RESULTS: Both methods generated a positive correlation to failure load of the respective vertebrae. The correlation of peak breakaway torque to failure load was r = 0.959 (P = 0.003), therewith distinctly higher than the correlation of indentation force to failure load, which was r = 0.690 (P = 0.040). In predicting regional BMD, measurement of peak torque also performed better than that of indentation force (r = 0.897 [P = 0.002] vs. r = 0.777 [P = 0.017]). CONCLUSION: Transpedicular measurement of peak breakaway torque is technically feasible and predicts reliable local bone strength and implant failure for dorsal spinal instrumentations in this experimental setting.

Quantification of bone strength by intraoperative torque measurement: a technical note.

INTRODUCTION: Bone strength describes the resistance of bone against mechanical failure. Bone strength depends on both the amount of bone and the bone's quality, and the bone strength may be looked upon as a relevant parameter to judge an osteosynthesis' stability. Information about bone strength was barely available intraoperatively in the past. The previous work of our group reported on development and laboratory evaluation of mechanical torque measurement as a method for the intraoperative quantification of bone strength. With the clinical series presented here we intend to verify that the im gesamten Text DensiProbe instrumentation for intraoperative torque measurement and the related measurement method are eligible for intraoperative use based on the following criteria: application of the method may not create complications, the measurement can be performed by the surgeon himself and may only cause a limited increase in the procedure time. PATIENTS AND METHODS: From December 2006 until May 2007 ten patients with a pertrochanteric femoral fracture or a lateral femoral neck fracture eligible for stabilization with DHS were included in the study after having received informed consent. Any medication and comorbidity that might have influenced bone quality or bone mineral density (BMD) in these patients was documented. Bone strength was intraoperatively measured with DensiProbe. Complications that were obviously related with torque measurement were documented as well as any deviation from the suggested procedure; 6 and 12 weeks postoperative follow-up included clinical and radiological examination. The time required for torque measurement, the overall operating time and the number of persons present in the operating room were protocolled. BMD values of the contralateral femoral neck were postoperatively assessed by dual energy X-ray absorptiometry (DEXA) and compared to intraoperative peak torque values measured by DensiProbe. RESULTS: No major complication was observed during intraoperative application of DensiProbe by trained surgeons. The unintended extraction of the guide wire together with the torque measurement probe was reported only once and is looked upon as a minor complication. Fracture healing was uneventful in all patients. The mean time for torque measurement was 2.35 +/- 0.9 min accounting for 2.2 +/- 1.1% of total surgery time. The presence of an additional person was not required to perform torque measurement but to protocol the data. There was a tendency towards correlation between BMD values of the femoral neck and intraoperative peak torque values. DISCUSSION: The data presented clearly indicate that the DensiProbe instrumentation and measurement principle are eligible for routine intraoperative use by trained surgeons. Interpretation of possible correlations between BMD values measured by means of DEXA and the Peak Torque values assessed by DensiProbe has to be considered very carefully, because BMD and Peak Torque analyse bone at a different scale. Only within the framework of a multicenter study it will be possible to include a sufficient number of patients for calculation of the methods' predictive value towards implant failure and to verify acceptance of the method by the surgeons.

Mechanical torque measurement predicts load to implant cut-out: a biomechanical study investigating DHS anchorage in femoral heads.

INTRODUCTION: Bone strength plays an important role in implant anchorage. Bone mineral density (BMD) is used as surrogate parameter to quantify bone strength and to predict implant anchorage. BMD can be measured by means of quantitative computer tomography (QCT) or dual energy X-ray absorptiometry (DXA). These noninvasive methods for BMD measurement are not available pre- or intra-operatively. Instead, the surgeon could determine bone strength by direct mechanical measurement. We have evaluated mechanical torque measurement for (A) its capability to quantify local bone strength and (B) its predictive value towards load at implant cut-out. MATERIALS AND METHODS: Our experimental study was performed using sixteen paired human cadaver proximal femurs. BMD was determined for all specimens by QCT. The torque to breakaway of the cancellous bone structure (peak torque) was measured by means of a mechanical probe at the exact position of subsequent DHS placement. The fixation strength of the DHS achieved was assessed by cyclic loading in a stepwise protocol beginning with 1,500 N increasing 500 N every 5,000 cycles until 4,000 N. RESULTS: A highly significant correlation of peak torque with BMD (QCT) was found (r = 0.902, r (2) = 0.814, P < 0.001). Peak torque correlated highly significant with the load at implant cut-out (r = 0.795, P < 0.001). All specimens with a measured peak torque below 6.79 Nm failed at the first load level of 1,500 N. The specimens with a peak torque above 8.63 Nm survived until the last load level of 4,000 N. CONCLUSION: Mechanical peak torque measurement is able to quantify bone strength. In an experimental setup, peak torque identifies those specimens that are likely to fail at low load. In clinical routine, implant migration and cut-out depend on several parameters, which are difficult to control, such as fracture type, fracture reduction achieved, and implant position. The predictive value of peak torque towards cut-out in a clinical set-up therefore has to be carefully validated.