Novel technique for repairing posterior medial meniscus root tears using porcine knees and biomechanical study.

Transtibial pullout suture (TPS) repair of posterior medial meniscus root (PMMR) tears was shown to achieve good clinical outcomes. The purpose of this study was to compare biomechanically, a novel technique designed to repair PMMR tears using tendon graft (TG) and conventional TPS repair. Twelve porcine tibiae (n = 6 each) TG group: flexor digitorum profundus tendon was passed through an incision in the root area, created 5 mm postero-medially along the edge of the attachment area. TPS group: a modified Mason-Allen suture was created using no. 2 FiberWire. The tendon grafts and sutures were threaded through the bone tunnel and then fixed to the anterolateral cortex of the tibia. The two groups underwent cyclic loading followed by a load-to-failure test. Displacements of the constructs after 100, 500, and 1000 loading cycles, and the maximum load, stiffness, and elongation at failure were recorded. The TG technique had significantly lower elongation and higher stiffness compared with the TPS. The maximum load of the TG group was significantly lower than that of the TPS group. Failure modes for all specimens were caused by the suture or graft cutting through the meniscus. Lesser elongation and higher stiffness of the constructs in TG technique over those in the standard TPS technique might be beneficial for postoperative biological healing between the meniscus and tibial plateau. However, a slower rehabilitation program might be necessary due to its relatively lower maximum failure load.

Effect of different inner core diameters on structural strength of cannulated pedicle screws under various lumbar spine movements.

BACKGROUND: Currently, cannulated pedicle screws have been widely used in minimal invasive or navigation techniques. However, the stress distribution and the strength of different core diameters of cannulated screw are not clear. This study aimed to investigate the mechanical strength of cannulated screws with different inner core diameter under various lumbar spine movements using finite element analysis. RESULTS: The results showed that the von-Mises stress of a cannulated screw was larger than that of a solid screw in all loading conditions, especially above 2 mm in cannulated core diameter. In lateral bending, extension, and flexion, the maximum von-Mises stress was found approximate to the proximal thread for all types of screws. In rotation condition, the maximum von-Mises stress was located at the middle of the screw. Additionally, the difference in stiffness of instrumented levels was not significant among four screws under the same loading condition. CONCLUSION: Cannulated screws could provide enough stability for the vertebral body fusion comparing to solid screws. The diameter of cannulated core is suggested not to exceed 2.0 mm.

Biomechanical evaluation of a novel pedicle screw-based interspinous spacer: A finite element analysis.

Interspinous spacers have been designed to provide a minimally invasive surgical technique for patients with lumbar spinal stenosis or foraminal stenosis. A novel pedicle screw-based interspinous spacer has been developed in this study, and the aim of this finite element experiment was to investigate the biomechanical differences between the pedicle screw-based interspinous spacer (M-rod system) and the typical interspinous spacer (Coflex-F™). A validated finite element model of an intact lumbar spine was used to analyze the insertions of the Coflex-F™, titanium alloy M-rod (M-Ti), and polyetheretherketone M-rod (M-PEEK), independently. The range of motion (ROM) between each vertebrae, stiffness of the implanted level, the peak stress at the intervertebral discs, and the contact forces on spinous process were analyzed. Of all three devices, the Coflex-F™ provided the largest restrictions in extension, flexion and lateral bending. For intervertebral disc, the peak stress at the implanted segment decreased by 81% in the Coflex-F™, 60.2% in the M-Ti and 46.7% in the M-PEEK when compared to the intact model. For the adjacent segments, while the Coflex-F™ caused considerable increases in the ROM and disc stress, the M-PEEK only had small changes.

Measurement of Tip Apex Distance and Migration of Lag Screws and Novel Blade Screw Used for the Fixation of Intertrochanteric Fractures.

Fixation with a dynamic hip screw (DHS) is one of the most common methods for stabilizing intertrochanteric fractures, except for unstable and reverse oblique fracture types. However, failure is often observed in osteoporotic patients whereby the lag screw effectively 'cuts out' through the weak bone. Novel anti-migration blades have been developed to be used in combination with a lag screw ('Blade Screw') to improve the fixation strength in osteoporotic intertrochanteric fractures. An in-vitro biomechanical study and a retrospective clinical study were performed to evaluate lag screw migration when using the novel Blade Screw and a traditional threaded DHS. The biomechanical study showed both the Blade Screw and DHS displayed excessive migration (≥10 mm) before reaching 20,000 loading cycles in mild osteoporotic bone, but overall migration of the Blade Screw was significantly less (p ≤ 0.03). Among the patients implanted with a Blade Screw in the clinical study, there was no significant variation in screw migration at 3-months follow-up (P = 0.12). However, the patient's implanted with a DHS did display significantly greater migration (P<0.001) than those implanted with the Blade Screw. In conclusion, the Blade Screw stabilizes the bone fragments during dynamic loading so as to provide significantly greater resistance to screw migration in patients with mild osteoporosis.

Translational research of one dynamic hip screw system-from the SCI to the FDA.

BACKGROUND/OBJECTIVE: When researchers or developers wish to apply their findings to clinical usages, it must be approved by public authorities such as the US Food and Drug Administration (FDA). In addition to the development records and risk control documents, all of the materials and testing must be completed by laboratories or manufacturers with good quality controls in accordance with related regulations or standards. The Orthopaedic Device Research Center dynamic hip screw system (ODRC-DHS system), which was developed by the ODRC, National Yang-Ming University, Taipei, Taiwan, obtained FDA 510(k) clearance in 2011. METHODS: The application process was divided into five steps: (1) make sure that the product is a medical device and classify it; (2) find the predicate devices cleared by the FDA; (3) research any standards and/or guidance documents; (4) prepare the appropriate information for premarket submission to the FDA; and (5) send premarket submission to the FDA and interact with the FDA staff. RESULTS AND CONCLUSION: The relevant regulations, guidelines, and strategies were detailed by step-by-step demonstration so that readers can quickly understand the requirements and know-how of a translational research.

Effect of different radial hole designs on pullout and structural strength of cannulated pedicle screws.

Cannulated pedicle screws are designed for bone cement injection to enhance fixation strength in severely osteoporotic spines. However, the screws commonly fracture during insertion. This study aims to evaluate how different positions/designs of radial holes may affect the pullout and structural strength of cannulated pedicle screws using finite element analysis. Three different screw hole designs were evaluated under torsion and bending conditions. The pullout strength for each screw was determined by axial pullout failure testing. The results showed that when the Von Mises stress reached the yield stress of titanium alloy the screw with four radial holes required a greater torque or bending moment than the nine and twelve hole screws. In the pullout test, the strength and stiffness of each screw with cement augmentation showed no significant differences, but the screw with four radial holes had a greater average pullout strength, which probably resulted from the significantly greater mean maximum lengths of cement augmentation. Superior biomechanical responses, with lower stress around the radial holes and greater pullout strength, represented by cannulated pedicle screw with four radial holes may worth recommending for clinical application.

The effect of graft strength on knee laxity and graft in-situ forces after posterior cruciate ligament reconstruction.

Surgical reconstruction is generally recommended for posterior cruciate ligament (PCL) injuries; however, the use of grafts is still a controversial problem. In this study, a three-dimensional finite element model of the human tibiofemoral joint with articular cartilage layers, menisci, and four main ligaments was constructed to investigate the effects of graft strengths on knee kinematics and in-situ forces of PCL grafts. Nine different graft strengths with stiffness ranging from 0% (PCL rupture) to 200%, in increments of 25%, of an intact PCL's strength were used to simulate the PCL reconstruction. A 100 N posterior tibial drawer load was applied to the knee joint at full extension. Results revealed that the maximum posterior translation of the PCL rupture model (0% stiffness) was 6.77 mm in the medial compartment, which resulted in tibial internal rotation of about 3.01°. After PCL reconstruction with any graft strength, the laxity of the medial tibial compartment was noticeably improved. Tibial translation and rotation were similar to the intact knee after PCL reconstruction with graft strengths ranging from 75% to 125% of an intact PCL. When the graft's strength surpassed 150%, the medial tibia moved forward and external tibial rotation greatly increased. The in-situ forces generated in the PCL grafts ranged from 13.15 N to 75.82 N, depending on the stiffness. In conclusion, the strength of PCL grafts have has a noticeable effect on anterior-posterior translation of the medial tibial compartment and its in-situ force. Similar kinematic response may happen in the models when the PCL graft's strength lies between 75% and 125% of an intact PCL.

Is the posterior cruciate ligament necessary for medial pivot knee prostheses with regard to postoperative kinematics?

PURPOSE: Excellent clinical and kinematical performance is commonly reported after medial pivot knee arthroplasty. However, there is conflicting evidence as to whether the posterior cruciate ligament should be retained. This study simulated how the posterior cruciate ligament, post-cam mechanism and medial tibial insert morphology may affect postoperative kinematics. METHODS: After the computational intact knee model was validated according to the motion of a normal knee, four TKA models were built based on a medial pivot prosthesis; PS type, modified PS type, CR type with PCL retained and CR type with PCL sacrificed. Anteroposterior translation and axial rotation of femoral condyles on the tibia during 0°-135° knee flexion were analyzed. RESULTS: There was no significant difference in kinematics between the intact knee model and reported data for a normal knee. In all TKA models, normal motion was almost fully restored, except for the CR type with PCL sacrificed. Sacrificing the PCL produced paradoxical anterior femoral translation and tibial external rotation during full flexion. CONCLUSION: Either the posterior cruciate ligament or post-cam mechanism is necessary for medial pivot prostheses to regain normal kinematics after total knee arthroplasty. The morphology of medial tibial insert was also shown to produce a small but noticeable effect on knee kinematics. LEVEL OF EVIDENCE: V.

Biomechanical considerations in the design of high-flexion total knee replacements.

Typically, joint arthroplasty is performed to relieve pain and improve functionality in a diseased or damaged joint. Total knee arthroplasty (TKA) involves replacing the entire knee joint, both femoral and tibial surfaces, with anatomically shaped artificial components in the hope of regaining normal joint function and permitting a full range of knee flexion. In spite of the design of the prosthesis itself, the degree of flexion attainable following TKA depends on a variety of factors, such as the joint's preoperative condition/flexion, muscle strength, and surgical technique. High-flexion knee prostheses have been developed to accommodate movements that require greater flexion than typically achievable with conventional TKA; such high flexion is especially prevalent in Asian cultures. Recently, computational techniques have been widely used for evaluating the functionality of knee prostheses and for improving biomechanical performance. To offer a better understanding of the development and evaluation techniques currently available, this paper aims to review some of the latest trends in the simulation of high-flexion knee prostheses.

Biomechanical study of expandable pedicle screw fixation in severe osteoporotic bone comparing with conventional and cement-augmented pedicle screws.

Pedicle screws are widely utilized to treat the unstable thoracolumbar spine. The superior biomechanical strength of pedicle screws could increase fusion rates and provide accurate corrections of complex deformities. However, osteoporosis and revision cases of pedicle screw substantially reduce screw holding strength and cause loosening. Pedicle screw fixation becomes a challenge for spine surgeons in those scenarios. The purpose of this study was to determine if an expandable pedicle screw design could be used to improve biomechanical fixation in osteoporotic bone. Axial mechanical pull-out test was performed on the expandable, conventional and augmented pedicle screws placed in a commercial synthetic bone block which mimicked a human bone with severe osteoporosis. Results revealed that the pull-out strength and failure energy of expandable pedicle screws were similar with conventional pedicle screws augmented with bone cement by 2 ml. The pull-out strength was 5-fold greater than conventional pedicle screws and the failure energy was about 2-fold greater. Besides, the pull-out strength of expandable screw was reinforced by the expandable mechanism without cement augmentation, indicated that the risks of cement leakage from vertebral body would potentially be avoided. Comparing with the biomechanical performances of conventional screw with or without cement augmentation, the expandable screws are recommended to be applied for the osteoporotic vertebrae.

The effect of different humeral prosthesis fin designs on shoulder stability: a computational model.

Humeral prostheses commonly use a fin structure as an attachment point for the supraspinatus muscle in total shoulder arthroplasty (TSA), but these fins may cause injury to the muscle during implantation, inadvertently influencing stability. In order to prevent supraspinatus injury, the effect of different humeral prostheses on shoulder joint stability needs to be investigated. A commercially available prosthesis and two modified humeral prostheses that substituted the fin structure for 2 (2H) or 3 holes (3H) were evaluated using computational models. Glenohumeral abduction was simulated and the superioinferior/anterioposterior stability of the shoulder joint after TSA was calculated. The results revealed that the 2H design had better superioinferior stability than the other prostheses, but was still less stable than the intact shoulder. There were no obvious differences in anterioposterior stability, but the motion patterns were clearly distinguishable from the intact shoulder model. In conclusion, the 2H design showed better superioinferior stability than the 3H design and the commercial product during glenohumeral joint abduction; the three prostheses show similar results in anterioposterior stability. However, the stability of each tested prosthesis was not comparable to the intact shoulder. Therefore, as a compromise, the 2H design should be considered for TSA because of its superior stability.

Biomechanical analysis of different types of pedicle screw augmentation: a cadaveric and synthetic bone sample study of instrumented vertebral specimens.

This study aims to determine the pull-out strength, stiffness and failure pull-out energy of cement-augmented, cannulated-fenestrated pedicle screws in an osteoporotic cadaveric thoracolumbar model, and to determine, using synthetic bone samples, the extraction torques of screws pre-filled with cement and those with cement injected through perforations. Radiographs and bone mineral density measurements from 32 fresh thoracolumbar vertebrae were used to define specimen quality. Axial pull-out strength of screws was determined through mechanical testing. Mechanical pull-out strength, stiffness and energy-to-failure ratio were recorded for cement-augmented and non-cement-augmented screws. Synthetic bone simulating a human spinal bone with severe osteoporosis was used to measure the maximum extraction torque. The pull-out strength and stiffness-to-failure ratio of cement pre-filled and cement-injected screws were significantly higher than the non-cement-augmented control group. However, the cement pre-filled and cement-injected groups did not differ significantly across these values (p=0.07). The cement pre-filled group had the highest failure pull-out energy, approximately 2.8 times greater than that of the cement-injected (p<0.001), and approximately 11.5 times greater than that of the control groups (p<0.001). In the axial pull-out test, the cement-injected group had a greater maximum extraction torque than the cement pre-filled group, but was statistically insignificant (p=0.17). The initial fixation strength of cannulated screws pre-filled with cement is similar to that of cannulated screws injected with cement through perforations. This comparable strength, along with the heightened pull-out energy and reduced extraction torque, indicates that pedicle screws pre-filled with cement are superior for bone fixation over pedicle screws injected with cement.

Biomechanical comparisons between a new avascular necrosis of femaral head stem based on Chinese patients with avascular necrosis and two other designs.

BACKGROUND: There is a relatively high failure rate of the femoral component in patients with avascular necrosis at the intermediate-term follow-up. Improving the geometrical fit of the femoral stem against the medullary canal may help to provide long-term survivorship of the hip replacement for patients with avascular necrosis. METHODS: We designed a specific stem, based on morphometric studies of proximal femoral canals in Chinese avascular necrosis patients and evaluated the stem by finite element analyses, comparing the novel stem with two commercially available and commonly used stems. RESULTS: The morphometric data from avascular necrosis patients showed specific geometric differences in the proximal femoral canal, including profile curves in both the sagittal and coronary planes than the patients with femoral neck fracture. The shorter stemmed prostheses (Fitmore(®) and our stem) performed better than the longer stemmed prosthesis (VerSys(®)). CONCLUSIONS: This is the first study to investigate the femoral geometries of Chinese avascular necrosis patients. Our stem provides better stability and is theoretically beneficial to bone ingrowth, which may increase the long-term stability and fixation of the implant.

Concave polyethylene component improves biomechanical performance in lumbar total disc replacement--modified compressive-shearing test by finite element analysis.

Failure of ultra-high molecular weight polyethylene components after total disc replacements in the lumbar spine has been reported in several retrieval studies, but immediate biomechanical evidence for those mechanical failures remained unclear. Current study aimed to investigate the failure mechanisms of commercial lumbar disc prostheses and to enhance the biomechanical performances of polyethylene components by modifying the articulating surface into a convex geometry. Modified compressive-shearing tests were utilized in finite element analyses for comparing the contact, tensile, and shearing stresses on two commercial disc prostheses and on a concave polyethylene design. The influence of radial clearance on stress distributions and prosthetic stability were considered. The modified compressive-shearing test revealed the possible mechanisms for transverse and radial cracks of polyethylene components, and would be helpful in observing the mechanical risks in the early design stage. Additionally, the concave polyethylene component exhibited lower contact and shearing stresses and more acceptable implant stability when compared with the convex polyethylene design through all radial clearances. Use of a concave polyethylene component in lumbar disc replacements decreased the risk of transverse and radial cracks, and also helped to maintain adequate stability. This design concept should be considered in lumbar disc implant designs in the future.

Morphometrical measurement of resected surface of medial and lateral proximal tibia for Chinese population.

PURPOSE: The objective of this study was to analyze the morphology of the medial tibial plateau and lateral tibial plateau in Chinese knees and compared these measurements and features with those of commercial unicondylar tibial baseplates. METHODS: Three-dimensional knee models were reconstructed from computed tomography slices of 81 subjects. Among the series, 27 knees were from male subjects and 54 knees from female subjects. The dimensions and shape of the medial and lateral tibial plateaus were measured and compared with six commercially available unicondylar tibial baseplates. RESULTS: The results showed significant differences between the shapes of the medial and lateral tibial plateaus. For the lateral tibial plateau, the shape was symmetric about the mediolateral axis. The medial plateaus presented their widest mediolateral width in an obviously more posterior position than the lateral compartment. Additionally, the plateau aspect ratio decreased with increasing mediolateral dimensions, in contrast to the constant aspect ratio shown by conventional unicondylar knee prostheses. CONCLUSION: Compartment-specific designs may optimize coverage between the prosthesis and resected tibial surface. The morphometrical measurements presented may allow manufacturers to design tibial baseplates that accommodate the structural variability between different ethnic groups. LEVEL OF EVIDENCE: Prospective comparative study, Level II.

Biomechanical evaluation of proximal tibial behavior following unicondylar knee arthroplasty: modified resected surface with corresponding surgical technique.

Persistent pain and periprosthetic fracture of the proximal tibia are troublesome complications in modern unicondylar knee arthroplasty (UKA). Surgical errors and acute corners on the resected surface can place excessive strains on the bone, leading to bone degeneration. This study attempted to lower strains by altering the orthogonal geometry and avoiding extended vertical saw cuts. Finite element models were utilized to predict biomechanical behavior and were subsequently compared against experimental data. On the resected surface of the extended saw cut model, the greatest strains showed a 50% increase over a standard implant; conversely, the strains decreased by 40% for the radial-corner shaped model. For all UKA models, the peak strains below the resection level increased by 40% relative to an intact tibia. There was no significant difference among the implanted models. This study demonstrated that a large increase in strains arises on the tibial plateau to resist a cantilever-like bending moment following UKA. Surgical errors generally weaken the tibial support and increase the risk of fractures. This study provides guidance on altering the orthogonal geometry into a radial-shape to reduce strains and avoid degenerative remodeling. Furthermore, it could be expected that predrilling a posteriorly sloped tunnel through the tibia prior to cutting could achieve greater accuracy in surgical preparations.

Influence of post-cam design of posterior stabilized knee prosthesis on tibiofemoral motion during high knee flexion.

BACKGROUNDS: The post-cam design of contemporary posterior stabilized knee prosthesis can be categorized into flat-on-flat or curve-on-curve contact surfaces. The curve-on-curve design has been demonstrated its advantage of reducing stress concentration when the knee sustained an anteroposterior force with tibial rotation. How the post-cam design affects knee kinematics is still unknown, particularly, to compare the difference between the two design features. Analyzing knee kinematics of posterior stabilized knee prosthesis with various post-cam designs should provide certain instructions to the modification of prosthesis design. METHODS: A dynamic knee model was utilized to investigate tibiofemoral motion of various post-cam designs during high knee flexion. Two posterior stabilized knee models were constructed with flat-on-flat and curve-on-curve contact surfaces of post-cam. Dynamic data of axial tibial rotation and femoral translation were measured from full-extension to 135°. FINDINGS: Internal tibial rotation increased with knee flexion in both designs. Before post-cam engagement, the magnitude of internal tibial rotation was close in the two designs. However, tibial rotation angle decreased beyond femoral cam engaged with tibial post. The rate of reduction of tibial rotation was relatively lower in the curve-on-curve design. From post-cam engagement to extreme flexion, the curve-on-curve design had greater internal tibial rotation. INTERPRETATION: Motion constraint was generated by medial impingement of femoral cam on tibial post. It would interfere with the axial motion of the femur relative to the tibia, resulting in decrease of internal tibial rotation. Elimination of rotational constraint should be necessary for achieving better tibial rotation during high knee flexion.

Anatomic-like polyethylene insert could improve knee kinematics after total knee arthroplasty--a computational assessment.

BACKGROUNDS: Deficiencies in contemporary posterior crucitate retaining knee included inadequate femoral rollback and insufficient tibial rotation. Current study attempted to restore normal femoral rollback and tibial rotation to facilitate in knee flexion/extension and to achieve appropriate posture at deep knee bending after total knee arthroplasy by mimicking the morphology of convexly lateral tibial plateau of intact knee. METHODS: Computational simulation was utilized to analyze motion of three-dimensional knee models, including intact, traditionally symmetrical posterior crucitate retaining and newly anatomic-like posterior crucitate retaining knees. Solid bones, attachments of ligaments and tendons of simulation models were reconstructed by magnetic resonance images of the subject. According to the representative literature, the distal femur was modeled to rotate about the specific axes and the motion of the proximal tibial was unconstrained except for the flexion/extension. Movements of the medial/lateral condyles and tibial rotation were recorded and analyzed. FINDINGS: The newly anatomic-like posterior crucitate retaining knee improved the posterior movement of lateral condyle and tibial internal rotation significantly during full range of flexion. Compared with traditionally symmetrical posterior crucitate retaining knee, the improvements displayed by newly developed posterior crucitate retaining knee in posterior movement of lateral condyle and tibial internal rotation were 11.2mm and 9.3° at full flexion, respectively. INTERPRETATION: The newly anatomic-like posterior crucitate retaining knee demonstrated that mimicking the morphology of convexly lateral tibial plateau can be expected to restore normal knee kinematics.

Incidence of hip replacement among national health insurance enrollees in Taiwan.

BACKGROUND: There is no national joint replacement registry in the country of Asia and reports of national outcomes of joint replacement in Asia as yet. Therefore, this study was then to report a national data of the number of hip replacements, incidence rate, demographic characteristics of hip replacement patients, and short-time survival rate after hip replacement of Han Chinese in Taiwan. METHODS: We analyzed 105,688 cases of hip replacements (including primary partial hip replacement, primary total hip replacement and revision of hip replacement) from National Health Insurance research database between 1996 and 2004. The survival rate of primary hip replacement was estimated for each disease by the Kaplan-Meier method. RESULTS: Average annual number of primary partial hip replacement and primary total hip replacement were 4,257 and 6,206 cases, respectively. The most two common diagnosis of primary partial hip replacement were femoral neck fractures (73.6%, 34% men, mean age 76 years) and avascular necrosis (18.0%, 84% men, mean age 48 years). In primary total hip replacements, the most two common diagnosis were avascular necrosis (46.9%, 79% men, mean age 50 years) and osteoarthrosis (41.6%, 43% men, mean age 60 years). Both the number of primary partial hip replacements and primary total hip replacements increased steadily between 1996 and 2004. The cumulative survival of primary partial hip replacements and primary total hip replacements in all patients were 93.97% and 79.47% in 9 years follow-up, respectively. CONCLUSION: Avascular necrosis is the main disease in total hip replacement in Taiwan. The epidemiology of hip diseases was different between Han Chinese (in Taiwan) and Caucasian and the number of hip replacements increased substantially in Taiwan between 1996 and 2004.