A Novel and Inexpensive Technique for High-Tension Tendon Clamping With Expandable Mesh Sleeving for In Vitro Foot Biomechanics Testing.

In vitro biomechanical testing is common in the field of orthopedics when novel devices are investigated prior to human trials. It is typically necessary to apply loads through tendons to simulate normal activities, such as walking during a foot and ankle study. However, attachment of tendons to linear actuators has proven challenging because of the tendency of clamps to either slip off or rupture the tendon. Various techniques have been utilized. Freeze clamping is generally accepted as the gold standard for very high load testing in excess of 3000 N, but is expensive, time-consuming, and requires significant ancillary equipment. Purely mechanical solutions such as metal jaw clamps, wire meshes, and others have been explored, but these techniques are either costly, have low load capacities, or have not proven to be reproducible. We have developed a novel tendon clamping technique that utilizes a slip-resistant polyester mesh sleeving that encases the tendon and is fixated at the bottom of the tendon/sleeve interaction with a giftbox suture. The loose end of the sleeving can then be tied in to the linear actuator or load cell apparatus using a timber hitch knot. The sleeving technique allows for loads of 2000-2500 N on the Achilles tendon, and is inexpensive, reproducible, and can be modified to apply loads to smaller tendons as well, though a length of tendon/sleeve overlap of at least 16 cm is required to reach maximum loads. This technique should assist researchers in integrating muscle forces into future biomechanical study designs.

Assessment of L5-S1 anterior lumbar interbody fusion stability in the setting of lengthening posterior instrumentation constructs: a cadaveric biomechanical study.

OBJECTIVE: Excessive stress and motion at the L5-S1 level can lead to degenerative changes, especially in patients with posterior instrumentation suprajacent to L5. Attention has turned to utilization of L5-S1 anterior lumbar interbody fusion (ALIF) to stabilize the lumbosacral junction. However, questions remain regarding the effectiveness of stand-alone ALIF in the setting of prior posterior instrumented fusions terminating at L5. The purpose of this study was to assess the biomechanical stability of an L5-S1 ALIF with increasing lengths of posterior thoracolumbar constructs. METHODS: Seven human cadaveric spines (T9-sacrum) were instrumented with pedicle screws from T10 to L5 and mounted to a 6 degrees-of-freedom robot. Posterior fusion construct lengths (T10-L5, T12-L5, L2-5, and L4-5) were instrumented to each specimen, and torque-fusion level relationships were determined for each construct in flexion-extension, axial rotation, and lateral bending. A stand-alone L5-S1 ALIF was then instrumented, and L5-S1 motion was measured as increasing pure moments (2 to 12 Nm) were applied. Motion reduction was calculated by comparing L5-S1 motion across the ALIF and non-ALIF states. RESULTS: The average motion at L5-S1 in axial rotation, flexion-extension, and lateral bending was assessed for each fusion construct with and without ALIF. After adding ALIF to a posterior fusion, L5-S1 motion was significantly reduced relative to the non-ALIF state in all but one fused surgical condition (p < 0.05). Longer fusions with ALIF produced larger L5-S1 motions, and in some cases resulted in motions higher than native state motion. CONCLUSIONS: Posterior fusion constructs up to L4-5 could be appropriately stabilized by a stand-alone L5-S1 ALIF when using a nominal threshold of 80% reduction in native motion as a potential positive indicator of fusion. The results of this study allow conclusions to be drawn from a biomechanical standpoint; however, the clinical implications of these data are not well defined. These findings, when taken in appropriate clinical context, can be used to better guide clinicians seeking to treat L5-S1 pathology in patients with prior posterior thoracolumbar constructs.

Evaluating stability of the craniovertebral junction after unilateral C1 lateral mass resection: implications for the direct lateral approach.

OBJECTIVE: The direct lateral approach is an alternative to the transoral or endonasal approaches to ventral epidural lesions at the lower craniocervical junction. In this study, the authors performed, to their knowledge, the first in vitro biomechanical evaluation of the craniovertebral junction after sequential unilateral C1 lateral mass resection. The authors hypothesized that partial resection of the lateral mass would not result in a significant increase in range of motion (ROM) and may not require internal stabilization. METHODS: The authors performed multidirectional in vitro ROM testing using a robotic spine testing system on 8 fresh cadaveric specimens. We evaluated ROM in 3 primary movements (axial rotation [AR], flexion/extension [FE], and lateral bending [LB]) and 4 coupled movements (AR+E, AR+F, LB + left AR, and LB + right AR). Testing was performed in the intact state, after C1 hemilaminectomy, and after sequential 25%, 50%, 75%, and 100% C1 lateral mass resection. RESULTS: There were no significant increases in occipital bone (Oc)-C1, C1-2, or Oc-C2 ROM after C1 hemilaminectomy and 25% lateral mass resection. After 50% resection, Oc-C1 AR ROM increased by 54.4% (p = 0.002), Oc LB ROM increased by 47.8% (p = 0.010), and Oc-C1 AR+E ROM increased by 65.8% (p < 0.001). Oc-C2 FE ROM increased by 7.2% (p = 0.016) after 50% resection; 75% and 100% lateral mass resection resulted in further increases in ROM. CONCLUSIONS: In this cadaveric biomechanical study, the authors found that unilateral C1 hemilaminectomy and 25% resection of the C1 lateral mass did not result in significant biomechanical instability at the occipitocervical junction, and 50% resection led to significant increases in Oc-C2 ROM. This is the first biomechanical study of lateral mass resection, and future studies can serve to validate these findings.

A generalized framework for determination of functional musculoskeletal joint coordinate systems.

Establishing anatomical coordinate systems (CS) from anatomical landmarks is sensitive to landmark selection. Vastly different results can be obtained amongst observers which can greatly affect the resulting joint kinematics. The aim of this study is to introduce an objective method for calculating functional CS definitions for bones in joints that observe three-cylindrical-joint kinematic chain decomposition methods and to apply the method on tibiofemoral joint specimens. This method is driven by low resistance joint motion during loading profiles and not from anatomical landmark selection. Two anatomical CS definitions were established from points collected by five observers, for twelve knees. The knees underwent passive flexion and internal/external rotation using the anatomical CSs. The kinematics from these profiles were used in linear least squares minimization of off-axis motions to redefine the tibia and femur origins, the femur flexion axis and the tibia internal rotation axis. Significant improvements in reproducibility of 7.4 mm (tibia origin, p < 0.001), 3.4 mm (femur origin, p < 0.001), and 2.9° (femur FE-axis, p < 0.001) between the two functional CSs compared to the two anatomical CSs were observed. Functional CSs led to significant decreases in off-axis motion during discrete passive flexion profiles. This new strategy for establishing functional CSs provides an objective approach that will reduce the effects of observer error in establishing CSs. Additionally, functional CSs allow for better interpretations of kinematic responses due to loading because effects of kinematic cross-talk is minimized.

Specimen specific imaging and joint mechanical testing data for next generation virtual knees.

Virtual knees, with specimen-specific anatomy and mechanics, require heterogeneous data collected on the same knee. Specimen-specific data such as the specimen geometry, physiological joint kinematics-kinetics and contact mechanics are necessary in the development of virtual knee specimens for clinical and scientific simulations. These data are also required to capture or evaluate the predictive capacity of the model to represent joint and tissue mechanical response. This document details the collection of magnetic resonance imaging data and, tibiofemoral joint and patellofemoral joint mechanical testing data. These data were acquired for a cohort of eight knee specimens representing different populations with varying gender, age and perceived health of the joint. These data were collected as part of the Open Knee(s) initiative. Imaging data when combined with joint mechanics data, may enable development and assessment of authentic specimen-specific finite element models of the knee. The data may also guide prospective studies for association of anatomical and biomechanical markers in a specimen-specific manner.

Reference data on in vitro anatomy and indentation response of tissue layers of musculoskeletal extremities.

The skin, fat, and muscle of the musculoskeletal system provide essential support and protection to the human body. The interaction between individual layers and their composite structure dictate the body's response during mechanical loading of extremity surfaces. Quantifying such interactions may improve surgical outcomes by enhancing surgical simulations with lifelike tissue characteristics. Recently, a comprehensive tissue thickness and anthropometric database of in vivo extremities was acquired using a load sensing instrumented ultrasound to enhance the fidelity of advancing surgical simulations. However detailed anatomy of tissue layers of musculoskeletal extremities was not captured. This study aims to supplement that database with an enhanced dataset of in vitro specimens that includes ultrasound imaging supported by motion tracking of the ultrasound probe and two additional full field imaging modalities (magnetic resonance and computed tomography). The additional imaging datasets can be used in conjunction with the ultrasound/force data for more comprehensive modeling of soft tissue mechanics. Researchers can also use the image modalities in isolation if anatomy of legs and arms is needed.

Development of a novel in vitro cadaveric model for analysis of biomechanics and surgical treatment of Bertolotti syndrome.

BACKGROUND CONTEXT: Bertolotti syndrome (BS) is caused by pseudoarticulation between an aberrant L5 transverse process and the sacral ala, termed a lumbosacral transitional vertebra (LSTV). BS is thought to cause low back pain and is treated with resection or fusion, both of which have shown success. Acquiring cadavers with BS is challenging. Thus, we combined 3D printing, based on BS patient CT scans, with normal cadaveric spines to create a BS model. We then performed biomechanical testing to determine altered kinematics from LSTV with surgical interventions. Force sensing within the pseudojoint modeled nociception for different trajectories of motion and surgical conditions. PURPOSE: This study examines alterations in spinal biomechanics with LSTVs and with various surgical treatments for BS in order to learn more about pain and degeneration in this condition, in order to help optimize surgical decision-making. In addition, this study evaluates BS histology in order to better understand the pathology and to help define pain generators-if, indeed, they actually exist. STUDY DESIGN/SETTING: Model Development: A retrospective patient review of 25 patients was performed to determine the imaging criteria that defines the classical BS patient. Surgical tissue was extracted from four BS patients for 3D-printing material selection. Biomechanical Analysis. This was a prospective cadaveric biomechanical study of seven spines evaluating spinal motions, and loads, over various surgical conditions (intact, LSTV, and LSTV with various fusions). Additionally, forces at the LSTV joint were measured for the LSTV and LSTV with fusion condition. Histological Analysis: Histologic analysis was performed prospectively on the four surgical specimens from patients undergoing pseudoarthrectomy for BS at our institution to learn more about potential pain generators. PATIENT SAMPLE: The cadaveric portion of the study involved seven cadaveric spines. Four patients were prospectively recruited to have their surgical specimens assessed histologically and biomechanically for this study. Patients under the age of 18 were excluded. OUTCOME MEASURES: Physiological measures recorded in this study were broken down into histologic analysis, tissue biomechanical analysis, and joint biomechanical analysis. Histologic analysis included pathologist interpretation of Hematoxylin and Eosin staining, as well as S-100 staining. Tissue biomechanical analysis included stiffness measurements. Joint biomechanical analysis included range of motion, resultant torques, relative axis angles, and LSTV joint forces. METHODS: This study received funding from the American Academy of Neurology Medical Student Research Scholarship. Three authors hold intellectual property rights in the simVITRO robotic testing system. No other authors had relevant conflicts of interest for this study. CT images were segmented for a representative BS patient and cadaver spines. Customized cutting and drilling guides for LSTV attachment were created for individual cadavers. 3D-printed bone and cartilage structural properties were based on surgical specimen stiffness, and specimens underwent histologic analysis via Hematoxylin and Eosin, as well as S-100 staining. Joint biomechanical testing was performed on the robotic testing system for seven specimens. Force sensors detected forces in the LSTV joint. Kruskal-Wallis tests and Dunnett's tests were used for statistical analysis with significance bounded to p<.05. RESULTS: LSTV significantly reduces motion at the L5-S1 level, particularly in lateral bending and axial rotation. Meanwhile, the LSTV increases adjacent segment motion significantly at the L2-L3 level, whereas other levels have nonsignificant trends toward increased motion with LSTV alone. Fusion involving L4-S1 (L4-L5 and L5-S1) to treat adjacent level degeneration associated with an LSTV is associated with a significant increase in adjacent segment motion at all levels other than L5-S1 compared to LSTV alone. Fusion of L5-S1 alone with LSTV significantly increases L3-L4 adjacent segment motion compared to LSTV alone. Last, ipsilateral lateral bending with or without ipsilateral axial rotation produces the greatest force on the LSTV, and these forces are significantly reduced with L5-S1 fusion. CONCLUSIONS: BS significantly decreases L5-S1 mobility, and increases some adjacent segment motion, potentially causing patient activity restriction and discomfort. Ipsilateral lateral bending with or without ipsilateral axial rotation may cause the greatest discomfort overall in these patients, and fusion of the L5-S1 or L4-S1 levels may reduce pain associated with these motions. However, due to increased adjacent segment motion with fusions compared to LSTV alone, resection of the joint may be the better treatment option if the superior levels are not unstable preoperatively. CLINICAL SIGNIFICANCE: This study's results indicate that patients with BS have significantly altered spinal biomechanics and may develop pain due to increased loading forces at the LSTV joint with ipsilateral lateral bending and axial rotation. In addition, increased motion at superior levels when an LSTV is present may lead to degeneration over time. Based upon results of LSTV joint force testing, these patients' pain may be effectively treated surgically with LSTV resection or fusion involving the LSTV level if conservative management fails. Further studies are being pursued to evaluate the relationship between in vivo motion of BS patients, spinal and LSTV positioning, and pain generation to gain a better understanding of the exact source of pain in these patients. The methodologies utilized in this study can be extrapolated to recreate other spinal conditions that are poorly understood, and for which few native cadaveric specimens exist.

Robotically Simulated Pivot Shift That Represents the Clinical Exam.

A thorough understanding of anterior cruciate ligament (ACL) function and the effects of surgical interventions on knee biomechanics requires robust technologies and simulation paradigms that align with clinical insight. In vitro orthopedic biomechanical testing for the elucidation of ACL integrity doesn't have an established testing paradigm to simulate the clinical pivot shift exam on cadaveric specimens. The study aim was to develop a robotically simulated pivot shift that represents the clinical exam. An orthopedic surgeon performed a pivot shift on an instrumented ACL-deficient cadaver leg to capture 6 degree-of-freedom motion/loads. The same knee was mounted to the robot and the sensitivity of the motion/loading profiles quantified. Three loading profile candidates that generated positive pivot shifts on the instrumented knee were selected and applied to 7 ACL-intact/deficient specimens and resulted in the identification of a profile that was able to induce a positive pivot shift in all ACL-deficient specimens ( p < 0.001). The simulated shifts began at 22 ± 8° and ended at 33 ± 6° of flexion with the average magnitude of the shifts being 12.8 ± 3.2 mm in anterior tibial translation and 17.6 ± 4.3° in external tibial rotation. The establishment and replication of a robotically simulated clinical pivot shift across multiple specimens show the robustness of the loading profile to accommodate anatomical and experimental variability. Further evaluation and refinement should be undertaken to create a useful tool in evaluating ACL function and reconstruction techniques. Statement of clinical significance: Creation and successful demonstration of the simulated clinical pivot shift validates a profile for robotic musculoskeletal simulators to analyze ACL related clinical questions. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 37:2601-2608, 2019.

Reference data on thickness and mechanics of tissue layers and anthropometry of musculoskeletal extremities.

Musculoskeletal extremities exhibit a multi-layer tissue structure that is composed of skin, fat, and muscle. Body composition and anthropometric measurements have been used to assess health status and build anatomically accurate biomechanical models of the limbs. However, comprehensive datasets inclusive of regional tissue anatomy and response under mechanical manipulation are missing. The goal of this study was to acquire and disseminate anatomical and mechanical data collected on extremities of the general population. An ultrasound system, instrumented with a load transducer, was used for in vivo characterization of skin, fat, and muscle thicknesses in the extremities of 100 subjects at unloaded (minimal force) and loaded (through indentation) states. For each subject, the unloaded and loaded state provided anatomic tissue layer measures and tissue indentation response for 48 and 8 regions, respectively. A publicly available web-based system has been used for data management and dissemination. This comprehensive database will provide the foundation for comparative studies in regional musculoskeletal composition and improve visual and haptic realism for computational models of the limbs.

The contribution of the acetabular labrum to hip joint stability: a quantitative analysis using a dynamic three-dimensional robot model.

The acetabular labrum provides mechanical stability to the hip joint in extreme positions where the femoral head is disposed to subluxation. We aimed to quantify the isolated labrum's stabilizing value. Five human cadaveric hips were mounted to a robotic manipulator, and subluxation potential tests were run with and without labrum. Three-dimensional (3D) kinematic data were quantified using the stability index (Colbrunn et al., 2013, "Impingement and Stability of Total Hip Arthroplasty Versus Femoral Head Resurfacing Using a Cadaveric Robotics Model," J. Orthop. Res., 31(7), pp. 1108-1115). Global and regional stability indices were significantly greater with labrum intact than after total labrectomy for both anterior and posterior provocative positions. In extreme positions, the labrum imparts significant overall mechanical resistance to hip subluxation. Regional stability contributions vary with joint orientation.

Biomechanical analysis of posterior cruciate ligament reconstruction with aperture femoral fixation.

The goal of this study was to determine whether single-tunnel-double-bundle-equivalent posterior cruciate ligament (PCL) reconstruction using an aperture femoral fixation device better replicated normal knee kinematics than single-bundle reconstruction. Eight fresh-frozen human cadaver knees underwent arthroscopically assisted PCL reconstruction and were examined with a robotic testing system to assess knee joint kinematics under combinations of applied internal, neutral, and external rotational tibial torque and anteroposterior translational forces at 0°, 30°, 60°, 90°, and 120° flexion. Three conditions were tested: (1) intact PCL; (2) single-tunnel PCL reconstruction with anterolateral and posteromedial bundle fixation at 90°/90° (single bundle); and (3) 90°/0° (double-bundle equivalent), respectively. Posterior tibial translation was the primary outcome measure. Compared with the intact knee, double-bundle-equivalent reconstruction under external tibial torque allowed greater posterior translation across the flexion arc as a whole (P=.025) and at 30° flexion (P=.027) when results were stratified by flexion angle. No other kinematic differences were found with single-bundle or double-bundle-equivalent fixation, including mediolateral translation and both coupled and isolated tibial rotation (P>.05). Single-bundle PCL reconstruction closely approximated native knee rotational and translational kinematics, whereas double-bundle-equivalent reconstruction permitted increased posterior translation with applied external tibial torque, particularly at lower flexion angles. Single-bundle PCL reconstruction provides knee stability similar to the intact condition, making it a practical alternative to conventional double-bundle PCL reconstruction. The authors found that double-bundle-equivalent reconstruction provided no advantage to justify its clinical use.

Biomechanical evaluation of a simulated T-9 burst fracture of the thoracic spine with an intact rib cage.

OBJECT: Classic biomechanical models have used thoracic spines disarticulated from the rib cage, but the biomechanical influence of the rib cage on fracture biomechanics has not been investigated. The well-accepted construct for stabilizing midthoracic fractures is posterior instrumentation 3 levels above and 2 levels below the injury. Short-segment fixation failure in thoracolumbar burst fractures has led to kyphosis and implant failure when anterior column support is lacking. Whether shorter constructs are viable in the midthoracic spine is a point of controversy. The objective of this study was the biomechanical evaluation of a burst fracture at T-9 with an intact rib cage using different fixation constructs for stabilizing the spine. METHODS: A total of 8 human cadaveric spines (C7-L1) with intact rib cages were used in this study. The range of motion (ROM) between T-8 and T-10 was the outcome measure. A robotic spine testing system was programmed to apply pure moment loads (± 5 Nm) in lateral bending, flexion-extension, and axial rotation to whole thoracic specimens. Intersegmental rotations were measured using an optoelectronic system. Flexibility tests were conducted on intact specimens, then sequentially after surgically induced fracture at T-9, and after each of 4 fixation construct patterns. The 4 construct patterns were sequentially tested in a nondestructive protocol, as follows: 1) 3 above/2 below (3A/2B); 2) 1 above/1 below (1A/1B); 3) 1 above/1 below with vertebral body augmentation (1A/1B w/VA); and 4) vertebral body augmentation with no posterior instrumentation (VA). A repeated-measures ANOVA was used to compare the segmental motion between T-8 and T-10 vertebrae. RESULTS: Mean ROM increased by 86%, 151%, and 31% after fracture in lateral bending, flexion-extension, and axial rotation, respectively. In lateral bending, there was significant reduction compared with intact controls for all 3 instrumented constructs: 3A/2B (-92%, p = 0.0004), 1A/1B (-63%, p = 0.0132), and 1A/1B w/VA (-66%, p = 0.0150). In flexion-extension, only the 3A/2B pattern showed a significant reduction (-90%, p = 0.011). In axial rotation, motion was significantly reduced for the 3 instrumented constructs: 3A/2B (-66%, p = 0.0001), 1A/1B (-53%, p = 0.0001), and 1A/1B w/VA (-51%, p = 0.0002). Between the 4 construct patterns, the 3 instrumented constructs (3A/2B, 1A/1B, and 1A/1B w/VA) showed comparable stability in all 3 motion planes. CONCLUSIONS: This study showed no significant difference in the stability of the 3 instrumented constructs tested when the rib cage is intact. Fractures that might appear more grossly unstable when tested in the disarticulated spine may be bolstered by the ribs. This may affect the extent of segmental spinal instrumentation needed to restore stability in some spine injuries. While these initial findings suggest that shorter constructs may adequately stabilize the spine in this fracture model, further study is needed before these results can be extrapolated to clinical application.

Mechanical evaluation of balloon-type gastrostomy devices.

Purpose is to evaluate the durability of two commonly used gastrostomy devices. The performance of balloon-type gastrostomy devices was evaluated in an accelerated aging failure mode as well as a feeding tube interlock pullout failure mode. Two commonly used devices were tested: MINI (Applied Medical Technology Inc.) and MIC-Key (Kimberly Clark/Ballard Medical). In the aging test, devices (n = 20) from each manufacturer were pressurized and subjected to controlled pH and temperature conditions to evaluate the product life. In the pullout failure test, devices were subjected to controlled mechanical loading to evaluate the force at which each plastic interlock pulls out of the rubber that encapsulates it. In the aging testing, the MIC-Key devices had a lifespan of 98 ± 34 h and the MINI survived for 1187 ± 422 h. The difference was statistically significant (p < 1 × 10-9). In the pullout testing, the MIC-Key failed at 183 ± 24 N whereas the MINI failed at 202 ± 26 N (p < 0.04). Pullout strength for both devices appears adequate in view of estimated in vivo loads during normal use of the device with the MINI requiring a statistically significantly greater pullout strength. Although the aging tests were performed using an accelerated protocol, the aging tests suggest that the in vivo lifespan and failure mode of the MINI may be superior to the MIC-Key.

Properties of an interspinous fixation device (ISD) in lumbar fusion constructs: a biomechanical study.

BACKGROUND: Segmental fixation improves fusion rates and promotes patient mobility by controlling instability after lumbar surgery. Efforts to obtain stability using less invasive techniques have lead to the advent of new implants and constructs. A new interspinous fixation device (ISD) has been introduced as a minimally invasive method of stabilizing two adjacent interspinous processes by augmenting an interbody cage in transforaminal interbody fusion. The ISD is intended to replace the standard pedicle screw instrumentation used for posterior fixation. PURPOSE: The purpose of this study is to compare the rigidity of these implant systems when supplementing an interbody cage as used in transforaminal lumbar interbody fusion. STUDY DESIGN: An in vitro human cadaveric biomechanical study. METHODS: Seven human cadaver spines (T12 to the sacrum) were mounted in a custom-designed testing apparatus, for biomechanical testing using a multiaxial robotic system. A comparison of segmental stiffness was carried out among five conditions: intact spine control; interbody spacer (IBS), alone; interbody cage with ISD; IBS, ISD, and unilateral pedicle screws (unilat); and IBS, with bilateral pedicle screws (bilat). An industrial robot (KUKA, GmbH, Augsburg, Germany) applied a pure moment (±5 Nm) in flexion-extension (FE), lateral bending (LB), and axial rotation (AR) through an anchor to the T12 vertebral body. The relative vertebral motion was captured using an optoelectronic camera system (Optotrak; Northern Digital, Inc., Waterloo, Ontario, Canada). The load sensor and the camera were synchronized. Maximum rotation was measured at each level and compared with the intact control. Implant constructs were compared with the control and with each other. A statistical analysis was performed using analysis of variance. RESULTS: A comparison between the intact spine and the IBS group showed no significant difference in the range of motion (ROM) in FE, LB, or AR for the operated level, L3-L4. After implantation of the ISD to augment the IBS, there was a significant decrease in the ROM of 74% in FE (p<.001) but no significant change in the ROM in LB and AR. The unilat construct significantly reduced the ROM by 77% compared with FE control (p<.001) and by 55% (p=.002) and 42% (p=.04) in LB and AR, respectively, compared with control. The bilat construct reduced the ROM in FE by 77% (p<.001), LB by 77% (p=.001), and AR by 65% (p=.001) when compared with the control spine. There was no statistically significant difference in the ROM in FE among the stand-alone ISD, unilat, and bilat constructs. However, in both LB and AR, the unilat and the bilat constructs were significantly stiffer (reduction in the ROM) than the ISD and the IBS combination. The ISD stability in LB and AR was not different from the intact control with no instrumentation at all. There was no statistical difference between the stability of the unilat and the bilat constructs in any direction. However, LB and AR in the unilat group produced a mean rotation of 3.83°±3.30° and 2.33°±1.33°, respectively, compared with the bilat construct that limited motion to 1.96°±1.46° and 1.39°±0.73°. There was a trend suggesting that the bilat construct was the most rigid construct. CONCLUSIONS: In FE, the ISD can provide lumbar stability comparable with Bilat instrumentation. It provides minimal rigidity in LB and AR when used alone to stabilize the segment after an IBS placement. The unilat and the more typical bilat screw constructs were shown to provide similar levels of stability in all directions after an IBS placement, though the bilat construct showed a trend toward improved stiffness overall.

Hybrid dynamic stabilization: a biomechanical assessment of adjacent and supraadjacent levels of the lumbar spine.

OBJECT: The object of this study was to evaluate the effect of hybrid dynamic stabilization on adjacent levels of the lumbar spine. METHODS: Seven human spine specimens from T-12 to the sacrum were used. The following conditions were implemented: 1) intact spine; 2) fusion of L4-5 with bilateral pedicle screws and titanium rods; and 3) supplementation of the L4-5 fusion with pedicle screw dynamic stabilization constructs at L3-4, with the purpose of protecting the L3-4 level from excessive range of motion (ROM) and to create a smoother motion transition to the rest of the lumbar spine. An industrial robot was used to apply continuous pure moment (± 2 Nm) in flexion-extension with and without a follower load, lateral bending, and axial rotation. Intersegmental rotations of the fused, dynamically stabilized, and adjacent levels were measured and compared. RESULTS: In flexion-extension only, the rigid instrumentation at L4-5 caused a 78% decrease in the segment's ROM when compared with the intact specimen. To compensate, it caused an increase in motion at adjacent levels L1-2 (45.6%) and L2-3 (23.2%) only. The placement of the dynamic construct at L3-4 decreased the operated level's ROM by 80.4% (similar stability as the fusion at L4-5), when compared with the intact specimen, and caused a significant increase in motion at all tested adjacent levels. In flexion-extension with a follower load, instrumentation at L4-5 affected only a subadjacent level, L5-sacrum (52.0%), while causing a reduction in motion at the operated level (L4-5, -76.4%). The dynamic construct caused a significant increase in motion at the adjacent levels T12-L1 (44.9%), L1-2 (57.3%), and L5-sacrum (83.9%), while motion at the operated level (L3-4) was reduced by 76.7%. In lateral bending, instrumentation at L4-5 increased motion at only T12-L1 (22.8%). The dynamic construct at L3-4 caused an increase in motion at T12-L1 (69.9%), L1-2 (59.4%), L2-3 (44.7%), and L5-sacrum (43.7%). In axial rotation, only the placement of the dynamic construct at L3-4 caused a significant increase in motion of the adjacent levels L2-3 (25.1%) and L5-sacrum (31.4%). CONCLUSIONS: The dynamic stabilization system displayed stability characteristics similar to a solid, all-metal construct. Its addition of the supraadjacent level (L3-4) to the fusion (L4-5) did protect the adjacent level from excessive motion. However, it essentially transformed a 1-level lumbar fusion into a 2-level lumbar fusion, with exponential transfer of motion to the fewer remaining discs.

Surface contaminants inhibit osseointegration in a novel murine model.

Surface contaminants, such as bacterial debris and manufacturing residues, may remain on orthopedic implants after sterilization procedures and affect osseointegration. The goals of this study were to develop a murine model of osseointegration in order to determine whether removing surface contaminants enhances osseointegration. To develop the murine model, titanium alloy implants were implanted into a unicortical pilot hole in the mid-diaphysis of the femur and osseointegration was measured over a five week time course. Histology, backscatter scanning electron microscopy and X-ray energy dispersive spectroscopy showed areas of bone in intimate physical contact with the implant, confirming osseointegration. Histomorphometric quantification of bone-to-implant contact and peri-implant bone and biomechanical pullout quantification of ultimate force, stiffness and work to failure increased significantly over time, also demonstrating successful osseointegration. We also found that a rigorous cleaning procedure significantly enhances bone-to-implant contact and biomechanical pullout measures by two-fold compared with implants that were autoclaved, as recommended by the manufacturer. The most likely interpretation of these results is that surface contaminants inhibit osseointegration. The results of this study justify the need for the development of better detection and removal techniques for contaminants on orthopedic implants and other medical devices.

Design and validation of a general purpose robotic testing system for musculoskeletal applications.

Orthopaedic research on in vitro forces applied to bones, tendons, and ligaments during joint loading has been difficult to perform because of limitations with existing robotic simulators in applying full-physiological loading to the joint under investigation in real time. The objectives of the current work are as follows: (1) describe the design of a musculoskeletal simulator developed to support in vitro testing of cadaveric joint systems, (2) provide component and system-level validation results, and (3) demonstrate the simulator's usefulness for specific applications of the foot-ankle complex and knee. The musculoskeletal simulator allows researchers to simulate a variety of loading conditions on cadaver joints via motorized actuators that simulate muscle forces while simultaneously contacting the joint with an external load applied by a specialized robot. Multiple foot and knee studies have been completed at the Cleveland Clinic to demonstrate the simulator's capabilities. Using a variety of general-use components, experiments can be designed to test other musculoskeletal joints as well (e.g., hip, shoulder, facet joints of the spine). The accuracy of the tendon actuators to generate a target force profile during simulated walking was found to be highly variable and dependent on stance position. Repeatability (the ability of the system to generate the same tendon forces when the same experimental conditions are repeated) results showed that repeat forces were within the measurement accuracy of the system. It was determined that synchronization system accuracy was 6.7+/-2.0 ms and was based on timing measurements from the robot and tendon actuators. The positioning error of the robot ranged from 10 microm to 359 microm, depending on measurement condition (e.g., loaded or unloaded, quasistatic or dynamic motion, centralized movements or extremes of travel, maximum value, or root-mean-square, and x-, y- or z-axis motion). Algorithms and methods for controlling specimen interactions with the robot (with and without muscle forces) to duplicate physiological loading of the joints through iterative pseudo-fuzzy logic and real-time hybrid control are described. Results from the tests of the musculoskeletal simulator have demonstrated that the speed and accuracy of the components, the synchronization timing, the force and position control methods, and the system software can adequately replicate the biomechanics of human motion required to conduct meaningful cadaveric joint investigations.

Effect of humeral head defect size on glenohumeral stability: a cadaveric study of simulated Hill-Sachs defects.

BACKGROUND: Hill-Sachs lesions are often present with recurrent shoulder instability and may be a cause of failed Bankart repair. HYPOTHESIS: Glenohumeral joint stability decreases with increasingly larger humeral head defects. STUDY DESIGN: Descriptive laboratory study. METHODS: Humeral head defects, 1/8, 3/8, 5/8, and 7/8 of the humeral head radius, were created in 8 human cadaveric shoulders, simulating Hill-Sachs defects. Testing positions included 45 degrees and 90 degrees of abduction and 40 degrees of internal rotation, neutral, and 40 degrees of external rotation. Testing occurred at each defect size sequentially from smallest to largest for all abduction and rotation combinations. The humeral head was translated at 0.5 mm/s 45 degrees anteroinferiorly to the horizontal glenoid axis until dislocation. Distance to dislocation, defined as humeral head translation until it began to subluxate, was the primary outcome measure. RESULTS: Significant factors by ANOVA were rotation (P < .001) and defect size (P < .001). There was no difference for the 2 abduction angles. External rotation of 40 degrees significantly reduced distance to dislocation compared with neutral and 40 degrees internal rotation (P < .001). Osteotomies of 5/8 and 7/8 radius significantly decreased distance to dislocation over the intact state (P = .009 and P <.001, respectively). Post hoc analysis determined significant differences for the rotational positions. Decreased distance to dislocation occurred at 5/8 radius osteotomy at 40 degrees external rotation with 90 degrees of abduction (P = .008). For the 7/8 radius osteotomy at 90 degrees abduction, there was a decreased distance to dislocation for neutral and 40 degrees external rotation (P < .001); at 45 degrees abduction, there was a decreased distance to dislocation at 40 degrees external rotation (P <.001). With the humerus internally rotated, there was no significant change in distance to dislocation. CONCLUSION: Glenohumeral stability decreases at a 5/8 radius defect in external rotation and abduction. At 7/8 radius, there was a further decrease in stability at neutral and external rotation. CLINICAL RELEVANCE: Defects of 5/8 the humeral head radius may require treatment to decrease the failure rate of shoulder instability repair.