Multidirectional flexibility analysis of cervical artificial disc reconstruction: in vitro human cadaveric spine model.

OBJECT: This in vitro experimental study was conducted to investigate the initial biomechanical effect of artificial intervertebral disc replacement in the cervical spine. The multidirectional flexibility of replaced and adjacent spinal segments were analyzed using a cadaveric cervical spine model. METHODS: The following three cervical reconstructions were sequentially performed at the C5-6 level after anterior discectomy in seven human cadaveric occipitocervical spines: anterior artificial disc replacement with a bioactive three-dimensional (3D) fabric disc (FD); anterior iliac bone graft; and anterior plate fixation with iliac bone graft. Six unconstrained pure moments were applied with a 6-df spine simulator, and 3D segmental motions at the operative and adjacent segments were measured with an optoelectronic motion measurement system. The 3D FD group demonstrated statistically equivalent ranges of motion (ROMs) when compared with intact values in axial rotation and lateral bending. The 45% increase in flexion-extension ROM was demonstrated in 3D FD group; however, neutral zone analysis did not reach statistical significance between the intact spine and 3D FD. The anterior iliac bone graft and iliac bone graft reconstructions demonstrated statistically lower ROMs when compared with 3D FD in all loading modes (p < 0.05). The adjacent-level ROMs of the 3D FD group demonstrated nearly physiological characteristics at upper and lower adjacent levels. Excellent stability at the interface was maintained during the whole testing without any device displacement and dislodgment. CONCLUSIONS: The stand-alone cervical 3D FD demonstrated nearly physiological biomechanical characteristics at both operative and adjacent spinal segments in vitro, indicating an excellent clinical potential for cervical artificial disc replacement

Multidirectional flexibility analysis of anterior and posterior lumbar artificial disc reconstruction: in vitro human cadaveric spine model.

The in vitro multidirectional flexibility analysis was conducted to investigate the initial biomechanical effect of biomimetic artificial intervertebral disc replacement from either anterior or posterior approach in a cadaveric lumbosacral spine model. Two designs of anterior total and posterior subtotal artificial discs were developed using bioactive three-dimensional fabric and bioresorbable hydroxyapatite/poly-l-lactide material (3DF disc). Both models were designed to obtain the stable interface bonding to vertebral endplates with maximum surface area occupation. Using seven cadaveric lumbosacral spines, the following three anterior reconstruction methods were sequentially performed at L4–5 level: anterior 3DF disc replacement; anterior BAK cages (BAK); and posterior pedicle screw fixation and anterior BAK cages combined (BAK + PS). The L2–3 level received two methods of posterior reconstructions: subtotal 3DF disc replacement (two implants), and posterior interbody cages and pedicle screw fixation (PLIF). Six unconstrained pure moments were applied and three-dimensional segmental motions were measured with an optoelectronic motion measurement system. The center of rotation (COR) calculation was conducted radiographically using flexion-extension films. Both anterior and posterior 3DF replacements statistically demonstrated equivalent range of motions (ROMs) in all loading modes compared to intact segment. Anterior BAK, BAK + PS, and PLIF demonstrated significantly lower ROMs when compared to intact and 3DF groups (P<0.05). The 3DF reconstruction tended to realign the COR to the posterior third or surrounding position at the operative disc level. The stand-alone lumbar 3DF disc replacement demonstrated biomechanical characteristics nearly equivalent to the intact spinal segments even through anterior or posterior approach in vitro, suggesting an excellent clinical potential

Two-year observation of artificial intervertebral disc replacement: results after supplemental ultra-high strength bioresorbable spinal stabilization.

OBJECT: This 2-year experimental study was conducted to investigate the efficacy of a bioactive three-dimensional (3D) fabric disc for lumbar intervertebral disc replacement. The authors used a bioresorbable spinal fixation rod consisting of a forged composite of particulate unsintered hydroxyapatite/poly-L-lactide acid (HA/PLLA) for stability augmentation. The biomechanical and histological alterations as well as possible device-related loosening were examined at 2 years postoperatively. METHODS: Two lumbar intervertebral discs (L2-3 and L4-5) were replaced with the 3D fabric discs, which were augmented by two titanium screws and a spanning bioresorbable rod (HA/PLLA). The segmental biomechanics and interface bone ingrowth were investigated at 6, 15, and 24 months postoperatively, and results were compared with the other two surgical groups (3D fabric disc alone; 3D fabric disc with additional anterior instrumentation stabilization). The 3D fabric disc and HA/PLLA-spinal segments demonstrated segmental mobility at 15 and 24 months; however, the range of motion (ROM) in flexion-extension decreased to 49 and 40%, respectively, despite statistically equivalent preserved torsional ROM. Histologically there was excellent osseous fusion at the 3D fabric disc surface-vertebral body interface. At 2 years posttreatment, no adverse tissue reaction nor aseptic loosening of the device was observed. CONCLUSIONS: Intervertebral disc replacement with the 3D fabric disc was viable and when used in conjunction with the bioresorbable HA/PLLA spinal augmentation. Further refinements of device design to create a stand-alone type are necessary to obviate the need for additional spinal stabilization

Bioactive and bioresorbable cellular cubic-composite scaffolds for use in bone reconstruction

We used a novel composite fibre-precipitation method to create bioactive and bioresorbable cellular cubic composites containing calcium phosphate (CaP) particles (unsintered and uncalcined hydroxyapatite (u-HA), α-tricalcium phosphate, β-tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate dihydrate, dicalcium phosphate anhydrate or octacalcium phosphate) in a poly-d/l-lactide matrix. The CaP particles occupied greater than or equal to 70 wt% (greater than or equal to 50 vol%) fractions within the composites. The porosities of the cellular cubic composites were greater than or equal to 70% and interconnective pores accounted for greater than or equal to 70% of these values. In vitro changes in the cellular geometries and physical properties of the composites were evaluated over time. The Alamar Blue assay was used to measure osteoblast proliferation, while the alkaline phosphatase assay was used to measure osteoblast differentiation. Cellular cubic C-u-HA70, which contained 70 wt% u-HA particles in a 30 wt% poly-d/l-lactide matrix, showed the greatest three-dimensional cell affinity among the materials tested. This composite had similar compressive strength and cellular geometry to cancellous bone, could be modified intraoperatively (by trimming or heating) and was able to form cortico-cancellous bone-like hybrids. The osteoinductivity of C-u-HA70, independent of biological growth factors, was confirmed by implantation into the back muscles of beagles. Our results demonstrated that C-u-HA70 has the potential as a cell scaffold or temporary hard-tissue substitute for clinical use in bone reconstruction