Cadaveric biomechanical studies of ADDISC total lumbar disc prosthesis.

BACKGROUND: Most total disc replacements provide excessive mobility and not reproduce spinal kinematics, inducing zygapophyseal joint arthritic changes and chronic back pain. In cadaveric lumbosacral spines, we studied if a new lumbar disc prosthesis kinematics mimics the intact intervertebral disc. METHODS: In eight cold preserved cadaveric lumbosacral spines, we registered the movement ranges in flexion, extension, right and left lateral bending, and rotation in the intact status, post-discectomy, and after our prosthesis implantation, comparing them for each specimen. FINDINGS: Comparing the intact lumbosacral spine with the L4-L5 prosthesis implanted specimens, we saw statistically significant differences in lateral bending and right rotation but not in the full range of rotation. Analyzing segments, we also noticed statistically significant differences at L4-L5 in flexion-extension and rotation. On the other hand, the L4-L5 discectomy, compared to the baseline spine condition, showed a statistically significant mobility increase in flexion, extension, lateral bending, and axial rotation, with an abnormal instantaneous center of rotation, which destabilizes the segment partly due to anterior annulus surgical removal. Disc prosthesis implantation reversed these changes in instantaneous center of rotation, but the prosthesis failed to restore the initial range of motion due to the destabilization of the ligaments in the operated disc. INTERPRETATION: The ADDISC total disc replacement reproduces the intact disc kinematics and Instantaneous Center of Rotation, but the prosthesis fails to restore the initial range of motion due to ligament destabilization. More studies will be necessary to define a technique that restores the damaged ligaments when implanting the prosthesis.

Bionate® nucleus disc replacement: bench testing comparing two different designs.

BACKGROUND: Intervertebral disc nucleus degeneration initiates a degenerative cascade and can induce chronic low back pain. Nucleus replacement aims to replace the nucleus while the annulus is still intact. Over time, several designs have been introduced, but the definitive solution continues to be elusive. Therefore, we aimed to create a new nucleus replacement that replicates intact intervertebral disc biomechanics, and thus has the potential for clinical applications. MATERIALS AND METHODS: Two implants with an outer ring and one (D2) with an additional midline strut were compared. Static and fatigue tests were performed with an INSTRON 8874 following the American Society for Testing and Materials F2267-04, F2346-05, 2077-03, D2990-01, and WK4863. Implant stiffness was analyzed at 0-300 N, 500-2000 N, and 2000-6000 N and implant compression at 300 N, 1000 N, 2000 N, and 6000 N. Wear tests were performed following ISO 18192-1:2008 and 18192-2:2010. GNU Octave software was used to calculate movement angles and parameters. The statistical analysis package R was used with the Deducer user interface. Statistically significant differences between the two designs were analyzed with ANOVA, followed by a post hoc analysis. RESULTS: D1 had better behavior in unconfined compression tests, while D2 showed a "jump." D2 deformed 1 mm more than D1. Sterilized implants were more rigid and deformed less. Both designs showed similar behavior under confined compression and when adding shear. A silicone annulus minimized differences between the designs. Wear under compression fatigue was negligible for D1 but permanent for D2. D1 suffered permanent height deformation but kept its width. D2 suffered less height loss than D1 but underwent a permanent width deformation. Both designs showed excellent responses to compression fatigue with no breaks, cracks, or delamination. At 10 million cycles, D2 showed 3-times higher wear than D1. D1 had better and more homogeneous behavior, and its wear was relatively low. It showed good mechanical endurance under dynamic loading conditions, with excellent response to axial compression fatigue loading without functional failure after long-term testing. CONCLUSION: D1 performed better than D2. Further studies in cadaveric specimens, and eventually in a clinical setting, are recommended. Level of evidence 2c.

Barbed Dental Ti6Al4V Alloy Screw: Design and Bench Testing.

BACKGROUND CONTEXT: Dental implants are designed to replace a missing tooth. Implant stability is vital to achieving osseointegration and successful implantation. Although there are many implants available on the market, there is room for improvement. PURPOSE: We describe a new dental implant with improved primary stability features. STUDY DESIGN: Lab bench test studies. METHODS: We evaluated the new implant using static and flexion-compression fatigue tests with compression loads, 35 Ncm tightening torque, displacement control, 0.01 mm/s actuator movement speed, and 9-10 Hz load application frequency, obtaining a cyclic load diagram. We applied variable cyclic loadings of predetermined amplitude and recorded the number of cycles until failure. The test ended with implant failure (breakage or permanent deformation) or reaching five million cycles for each load. RESULTS: Mean stiffness was 1151.13 ± 133.62 SD N/mm, mean elastic limit force 463.94 ± 75.03 SD N, and displacement 0.52 ± 0.04 SD mm, at failure force 663.21 ± 54.23 SD N and displacement 1.56 ± 0.18 SD mm, fatigue load limit 132.6 ± 10.4 N, and maximum bending moment 729.3 ± 69.43 mm/N. CONCLUSIONS: The implant fatigue limit is satisfactory for incisor and canine teeth and between the values for premolars and molars for healthy patients. The system exceeds five million cycles when subjected to a 132.60 N load, ensuring long-lasting life against loads below the fatigue limit.

ADDISC lumbar disc prosthesis: Analytical and FEA testing of novel implants.

The intact intervertebral disc is a six-freedom degree elastic deformation structure with shock absorption. "Ball-and-socket" TDR do not reproduce these properties inducing zygapophyseal joint overload. Elastomeric TDRs reproduce better normal disc kinematics, but repeated core deformation causes its degeneration. We aimed to create a new TDR (ADDISC) reproducing healthy disc features. We designed TDR, analyzed (Finite Element Analysis), and measured every 500,000 cycles for 10 million cycles of the flexion-extension, lateral bending, and axial rotation cyclic compression bench-testing. In the inlay case, we weighted it and measured its deformation. ADDISC has two semi-spherical articular surfaces, one rotation centre for flexion, another for extension, the third for lateral bending, and a polycarbonate urethane inlay providing shock absorption. The first contact is between PCU and metal surfaces. There is no metal-metal contact up to 2000 N, and CoCr28Mo6 absorbs the load. After 10 million cycles at 1.2-2.0 kN loads, wear 140.96 mg (35.50 mm3), but no implant failures. Our TDR has a physiological motion range due to its articular surfaces' shape and the PCU inlay bumpers, minimizing the facet joint overload. ADDISC mimics healthy disc biomechanics and Instantaneous Rotation Center, absorbs shock, reduces wear, and has excellent long-term endurance.

Bionate Lumbar Disc Nucleus Prosthesis: Biomechanical Studies in Cadaveric Human Spines.

DESIGN: cadaveric spine nucleus replacement study. OBJECTIVE: determining Bionate 80A nucleus replacement biomechanics in cadaveric spines. METHODS: in cold preserved spines, with ligaments and discs intact, and no muscles, L3-L4, L4-L5, and L5-S1 nucleus implantation was done. Differences between customized and overdimensioned implants were compared. Flexion, extension, lateral bending, and torsion were measured in the intact spine, nucleotomy, and nucleus implantation specimens. Increasing load or bending moment was applied four times at 2, 4, 6, and 8 Nm, twice in increasing mode and twice in decreasing mode. Spine motion was recorded using stereophotogrammetry. Expulsion tests: cyclic compression of 50-550 N for 50,000 cycles, increasing the load until there was extreme flexion, implant extrusion, or anatomical structure collapse. Subsidence tests were done by increasing the compression to 6000 N load. RESULTS: nucleotomy increased the disc mobility, which remained unchanged for the adjacent upper level but increased for the lower adjacent one, particularly in lateral bending and torsion. Nucleus implantation, compared to nucleotomy, reduced disc mobility except in flexion-extension and torsion, but intact mobility was no longer recovered, with no effect on upper or lower adjacent segments. The overdimensioned implant, compared to the customized implant, provided equal or sometimes higher mobility. Lamina, facet joint, and annulus removal during nucleotomy caused more damaged than that restored by nucleus implantation. No implant extrusion was observed under compression loads of 925-1068 N as anatomical structures collapsed before. No subsidence or vertebral body fractures were observed under compression loads of 6697.8-6812.3 N. CONCLUSIONS: nucleotomized disc and L1-S1 mobility increased moderately after cadaveric spine nucleus implantation compared to the intact status, partly due to operative anatomical damage. Our implant had shallow expulsion and subsidence risks.

Bionate Biocompatibility: In Vivo Study in Rabbits.

Response to foreign materials includes local tissue reaction, osteolysis, implant loosening, and migration to lymph nodes and organs. Bionate 80A human explants show minor wear and slight local tissue reaction, but we do not know the response at the spinal cord, nerve roots, lymph nodes, or distant organs. This study aims to figure out reactions against Bionate 80A when implanted at the spinal epidural space of 24 20-week-old New Zealand white rabbits. In one group of 12 rabbits, we implanted Bionate 80A on the spinal epidural space, and another group of 12 rabbits was used as the control group. We studied tissues, organs, and tissue damage markers on blood biochemistry, urine tests, and necropsy. The animals' clinical parameters and weight showed no statistically significant differences. At 3 months, the basophils increased slightly in the implant group, platelets decreased in all, and at 6 months, implanted animals showed slight eosinophilia, but none of these changes was statistically significant. External, organ, and spinal tissue examination showed neither toxic reaction, inflammatory changes, or noticeable differences between groups or survival periods. Under microscopic examination, the Bionate 80A particles induced a chronic granulomatous response always outside the dura mater, with giant multinucleated cells holding phagocytized particles and no particle migration to lymph nodes or organs. Thus, it was concluded that Bionate particles, when implanted in the rabbit lumbar epidural space, do not generate a significant reaction limited to the surrounding soft tissues with giant multinucleated cells. In addition, the particles did not cross the dura mater or migrate to lymph nodes or organs.

Finite Element Analysis of a Bionate Ring-Shaped Customized Lumbar Disc Nucleus Prosthesis.

Study design: Biomechanical study of a nucleus replacement with a finite element model. Objective: To validate a Bionate 80A ring-shaped nucleus replacement. Methods: The ANSYS lumbar spine model made from lumbar spine X-rays and magnetic resonance images obtained from cadaveric spine specimens were used. All materials were assumed homogeneous, isotropic, and linearly elastic. We studied three options: intact spine, nucleotomy, and nucleus implant. Two loading conditions were evaluated at L3-L4, L4-L5, and L5-S1 discs: a 1000 N axial compression load and this load after the addition of 8 Nm flexion moment in the sagittal plane plus 8 Nm axial rotation torque. Results: Maximum nucleus implant axial compression stresses in the range of 16-34 MPa and tensile stress in the range of 5-16 MPa, below Bionate 80A resistance were obtained. Therefore, there is little risk of permanent implant deformation or severe damage under normal loading conditions. Nucleotomy increased segment mobility, zygapophyseal joint and end plate pressures, and annulus stresses and strains. All these parameters were restored satisfactorily by nucleus replacement but never reached the intact status. In addition, annulus stresses and strains were lower with the nucleus implant than in the intact spine under axial compression and higher under complex loading conditions. Conclusions: Under normal loading conditions, there is a negligible risk of nucleus replacement, permanent deformation or severe damage. Nucleotomy increased segmental mobility, zygapophyseal joint pressures, and annulus stresses and strains. Nucleus replacement restored segmental mobility and zygapophyseal joint pressures close to the intact spine. End plate pressures were similar for the intact and nucleus implant conditions under both loading modes. Manufacturing customized nucleus implants is considered feasible, as satisfactory biomechanical performance is confirmed.

Talipes Equinovarus Treatment in Infants Treated by the Ponseti Method Compared With Posterior-Only Release: A Mid-Childhood Comparison of Results.

The aim of this study is to evaluate children in middle childhood with clubfoot treated with Ponseti method vs posterior-only release and to compare their results to a control group with 4 modules (physical examination, gait study, radiographic measurements, and questionnaires). From 01/01/2004 until 01/01/2009, 31 children (45 feet) were treated with the posterior-only release protocol and 22 patients (34 feet) were treated with the Ponseti method. In 2016, patients were evaluated and compared with 25 children without neuromuscular disorders. Parents completed 3 outcome questionnaires. Radiographs evaluated residual deformity and osteoarthritis. A physical examination and a 3-dimensional gait analysis were performed to evaluate range of motion, kinematic, and kinetic data. Recurrence rate was similar between treatment groups; however, type of surgery to treat residual deformity was more aggressive in the posterior-only release (91% required major surgery), p = .024. Radiographic examination showed similar residual deformity with greater hindfoot varus in posterior-only release (68%), p = .02. Reduced cadence, increased stance dorsiflexion, calcaneus gait and forced eversion prior to swing were the main characteristics of gait in posterior-only release. Four (11%) feet treated with posterior-only release vs 11 (33%) feet treated with Ponseti method had a normal gait, p = .016. Our study showed that biomechanical function and long-term outcomes of children in middle childhood treated with the Ponseti method more closely compare with healthy individuals than those treated using posterior-only surgical technique.

ICR in human cadaveric specimens: An essential parameter to consider in a new lumbar disc prosthesis design.

STUDY DESIGN: Biomechanical study in cadaveric specimens. BACKGROUND: The commercially available lumbar disc prostheses do not reproduce the intact disc's Instantaneous centre of Rotation (ICR), thus inducing an overload on adjacent anatomical structures, promoting secondary degeneration. AIM: To examine biomechanical testing of cadaveric lumbar spine specimens in order to evaluate and define the ICR of intact lumbar discs. MATERIAL AND METHODS: Twelve cold preserved fresh human cadaveric lumbosacral spine specimens were subjected to computerized tomography (CT), magnetic resonance imaging (MRI) and biomechanical testing. Kinematic studies were performed to analyse range of movements in order to determine ICR. RESULTS: Flexoextension and lateral bending tests showed a positive linear correlation between the angle rotated and the displacement of the ICR in different axes. DISCUSSION: ICR has not been taken into account in any of the available literature regarding lumbar disc prosthesis. Considering our results, neither the actual ball-and-socket nor the withdrawn elastomeric nucleus models fit the biomechanics of the lumbar spine, which could at least in part explain the failure rates of the implants in terms of postoperative failed back syndrome (low back pain). It is reasonable to consider then that an implant should also adapt the equations of the movement of the intact ICR of the joint to the post-surgical ICR. CONCLUSIONS: This is the first cadaveric study on the ICR of the human lumbar spine. We have shown that it is feasible to calculate and consider this parameter in order to design future prosthesis with improved clinical and biomechanical characteristics.

Biomechanical study of pelvic discontinuity in failed total hip arthroplasty. Lessons learnt from the treatment of pelvic fractures.

Pelvic discontinuity is a rare but serious problem in orthopedic surgery. Acetabular reconstruction in case of severe bone loss after failed total hip arthroplasty is technically difficult, especially in segmental loss type III (anterior or posterior) or pelvic discontinuity (type IV). Acetabular reinforcement devices are frequently used as load-sharing devices to allow allograft incorporation and in order to serve as support of acetabular implants. This study tries to show, by means of biomechanic work, the efficiency of reinforced plate in anterior column in a segmental pelvic loss, illustrated with a clinical case, which shows the socket stability of hip prosthesis.

Finite element analysis and cadaveric cinematic analysis of fixation options for anteriorly implanted trabecular metal interbody cages.

PURPOSE: To assess, with finite element analysis and an in vitro biomechanical study in cadaver, whether the implementation of an anterior interbody cage made of hedrocel with nitinol shape memory staples in compression increases the stiffness of the stand-alone interbody cage and to compare these constructs' stiffness to other constructs common in clinical practice. METHODS: A biomechanical study with a finite element analysis and cadaveric testing assessed the stiffness of different fixation modes for the L4-L5 functional spinal unit: intact spine, destabilized spine with discectomy, posterior pedicle-screw fixation, anterior stand-alone interbody cage, anterior interbody cage with bilateral pedicle screws and anterior interbody cage with two shape memory staples in compression. These modalities of vertebral fixation were compared in four loading modes (flexion, extension, lateral bending, and axial rotation). RESULTS: The L4-L5 spinal unit with an anterior interbody cage and two staples was stiffer than the stand-alone cage. The construct stiffness was similar to that of a model of posterior pedicular stabilization. The stiffness was lower than that of the anterior cage plus bilateral pedicle-screw fixation. CONCLUSION: The use of an anterior interbody implant with shape memory staples in compression may be an alternative to isolated posterior fixation and to anterior isolated implants, with increased stiffness.

Action of recombinant human BMP-2 on fracture healing in rabbits is dependent on the mechanical environment.

The utility of recombinant human bone morphogenetic protein-2 (rhBMP-2) in inducing bone formation in fractures of bone is well known. However, the influence of the mechanical environment on the actions of rhBMP-2 on fracture healing is not clear. An experimental model of fractures of the tibia in rabbits was developed and utilized to investigate the role of mechanical environment on rhBMP-2 action. A 1 mm osteotomy gap was stabilized by either a low- or high-stiffness fixator (LSF or HSF, respectively), and local treatment with rhBMP-2 in an absorbable collagen sponge (ACS) was evaluated. The results of the investigation were analysed by both histomorphometry and biomechanics. The LSF caused an increase in mineralized periosteal callus compared to HSF, the rhBMP-2 in ACS accelerated fracture healing only in the LSF group but not in the HSF group. The area of mineralized tissue in interfragmentary callus was determined by fixation stiffness and not by BMP treatment. rhBMP-2 caused higher bone resorption in the endosteal callus during the late stages of fracture healing, but these histological differences did not affect the mechanical properties. Biomechanical evaluation showed only differences at 3 weeks between LSF-rhBMP-2 and LSF-ACS. The bending and torsional properties were higher in the rhBMP-2/ACS group compared to ACS alone at 3 weeks.

Analysis of multiple waveforms by means of functional principal component analysis: normal versus pathological patterns in sit-to-stand movement.

This paper presents an application of functional principal component analysis (FPCA) to describe the inter-subject variability of multiple waveforms. This technique was applied to the study of sit-to-stand movement in two groups of people, osteoarthritic patients and healthy subjects. Although STS movement has not been extensively applied to the study of knee osteoarthritis, it can provide relevant information about the effect of osteoarthritis on knee joint function. Two waveforms, knee flexion angle and flexion moment, were analysed simultaneously. Instead of using the common multivariate approach we used the functional one, which allows working with continuous functions with neither discretization nor time-scale normalization. The results show that time-scale normalization can alter the FPCA solution. Furthermore, FPCA presents better discriminatory power compared with the classical multivariate approach. This technique can, therefore, be applied as a functional assessment tool, allowing the identification of relevant variables to discriminate heterogeneous groups such as healthy and pathological subjects.