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.