Biomechanical evaluation of different semi-rigid junctional fixation techniques using finite element analysis.

BACKGROUND: Proximal junctional failure is a common complication attributed to the rigidity of long pedicle screw fixation constructs used for surgical correction of adult spinal deformity. Semi-rigid junctional fixation achieves a gradual transition in range of motion at the ends of spinal instrumentation, which could lead to reduced junctional stresses, and ultimately reduce the incidence of proximal junctional failure. This study investigates the biomechanical effect of different semi-rigid junctional fixation techniques in a T8-L3 finite element spine segment model. METHODS: First, degeneration of the intervertebral disc was successfully implemented by altering the height. Second, transverse process hooks, one- and two-level clamped tapes, and one- and two-level knotted tapes instrumented proximally to three-level pedicle screw fixation were validated against ex vivo range of motion data of a previous study. Finally, the posterior ligament complex forces and nucleus pulposus stresses were quantified. FINDINGS: Simulated range of motions demonstrated the fidelity of the general model and modelling of semi-rigid junctional fixation techniques. All semi-rigid junctional fixation techniques reduced the posterior ligament complex forces at the junctional zone compared to pedicle screw fixation. Transverse process hooks and knotted tapes reduced nucleus pulposus stresses, whereas clamped tapes increased nucleus pulposus stresses at the junctional zone. INTERPRETATION: The relationship between the range of motion transition and the reductions in posterior ligament complex and nucleus pulposus stresses was complex and dependent on the fixation techniques. Clinical trials are required to compare the effectiveness of semi-rigid junctional fixation techniques in terms of reducing proximal junctional failure incidence rates.

Biomechanical evaluation of a novel biomimetic artificial intervertebral disc in canine cervical cadaveric spines.

Background Context: Cervical disc replacement (CDR) aims to restore motion of the treated level to reduce the risk of adjacent segment disease (ASD) compared with spinal fusion. However, first-generation articulating devices are unable to mimic the complex deformation kinematics of a natural disc. Thus, a biomimetic artificial intervertebral CDR (bioAID), containing a hydroxyethylmethacrylate (HEMA)-sodium methacrylate (NaMA) hydrogel core representing the nucleus pulposus, an ultra-high-molecular-weight-polyethylene fiber jacket as annulus fibrosus, and titanium endplates with pins for primary mechanical fixation, was developed. Purpose: To assess the initial biomechanical effect of the bioAID on the kinematic behavior of the canine spine, an ex vivo biomechanical study in 6-degrees-of-freedom was performed. Study Design: A canine cadaveric biomechanical study. Methods: Six cadaveric canine specimens (C3-C6) were tested in flexion-extension (FE), lateral bending (LB) axial rotation (AR) using a spine tester in three conditions: intact, after C4-C5 disc replacement with bioAID, and after C4-C5 interbody fusion. A hybrid protocol was used where first the intact spines were subjected to a pure moment of ±1 Nm, whereafter the treated spines were subjected to the full range of motion (ROM) of the intact condition. 3D segmental motions at all levels were measured while recording the reaction torsion. Biomechanical parameters studied included ROM, neutral zone (NZ), and intradiscal pressure (IDP) at the adjacent cranial level (C3-C4). Results: The bioAID retained the sigmoid shape of the moment-rotation curves with a NZ similar to the intact condition in LB and FE. Additionally, the normalized ROMs at the bioAID-treated level were statistically equivalent to intact during FE and AR while slightly decreased in LB. At the two adjacent levels, ROMs showed similar values for the intact compared to the bioAID for FE and AR and an increase in LB. In contrast, levels adjacent to the fused segment showed an increased motion in FE and LB as compensation for the loss of motion at the treated level. The IDP at the adjacent C3-C4 level after implantation of bioAID was close to intact values. After fusion, increased IDP was found compared with intact but did not reach statistical significance. Conclusion: This study indicates that the bioAID can mimic the kinematic behavior of the replaced intervertebral disc and preserves that for the adjacent levels better than fusion. As a result, CDR using the novel bioAID is a promising alternative treatment for replacing severely degenerated intervertebral discs.

Instrumentation Techniques to Prevent Proximal Junctional Kyphosis and Proximal Junctional Failure in Adult Spinal Deformity Correction: A Systematic Review of Clinical Studies.

STUDY DESIGN: Systematic review. OBJECTIVES: To summarize the results of clinical studies investigating spinal instrumentation techniques aiming to reduce the postoperative incidence of proximal junctional kyphosis (PJK) and/or failure (PJF) in adult spinal deformity (ASD) patients. METHODS: EMBASE and Medline® were searched for articles dating from January 2000 onward. Data was extracted by 2 independent authors and methodological quality was assessed using ROBINS-I. RESULTS: 18 retrospective- and prospective cohort studies with a severe or critical risk of bias were included. Different techniques were applied at the upper instrumented vertebra (UIV): tethers in various configurations, 2-level prophylactic vertebroplasty (2-PVP), transverse process hooks (TPH), flexible rods (FR), sublaminar tapes (ST) and multilevel stabilization screws (MLSS). Compared to a pedicle screw (PS) group, significant differences in PJK incidence were found using tethers in various configurations (18% versus 45%, P = 0.001, 15% versus 38%, P = 0.045), 2-PVP (24% vs 36%, P = 0.020), TPH (0% vs. 30%, P = 0.023) and FR (15% versus 38%, P = 0.045). Differences in revision rates for PJK were found in studies concerning tethers (4% versus 18%, P = 0.002), 2-PVP (0% vs 13%, P = 0.031) and TPH (0% vs 7%, P = n.a.). CONCLUSION: Although the studies are of low quality, the most frequently studied techniques, namely 2-PVP as anterior reinforcement and (tensioned) tethers or TPH as posterior semi-rigid fixation, show promising results. To provide a reliable comparison, more controlled studies need to be performed, including the use of clinical outcome measures and a uniform definition of PJF.

Biomechanical Evaluation of Semi-rigid Junctional Fixation Using a Novel Cable Anchor System to Prevent Proximal Junctional Failure in Adult Spinal Deformity Surgery.

STUDY DESIGN: A porcine cadaveric biomechanical study. OBJECTIVE: To biomechanically evaluate a novel Cable Anchor System as semi-rigid junctional fixation technique for the prevention of proximal junctional failure after adult spinal deformity surgery and to make a comparison to alternative promising prophylactic techniques. SUMMARY OF BACKGROUND DATA: The abrupt change of stiffness at the proximal end of a pedicle screw construct is a major risk factor for the development of proximal junctional failure after adult spinal deformity surgery. A number of techniques that aim to provide a gradual transition zone in range of motion (ROM) at the proximal junction have previously been studied. In this study, the design of a novel Cable Anchor System, which comprises a polyethylene cable for rod fixation, is assessed. METHODS: Ten T6-T13 porcine spine segments were subjected to cyclic 4 Nm pure-moment loading. The following conditions were tested: uninstrumented, 3 level pedicle screw fixation (PSF), and PSF with supplementary Cable Anchors applied proximally at 1-level (Anchor1) or 2-levels (Anchor2), transverse process hooks (TPH), and 2-level sublaminar tapes (Tape2). The normalized segmental range of motion in the junctional zone was compared using one-way analysis of variance and linear regression. RESULTS: Statistical comparison at the level proximal to PSF showed significantly lower ROMs for all techniques compared to PSF fixation alone in all movement directions. Linear regression demonstrated a higher linearity for Anchor1 (0.820) and Anchor2 (0.923) in the junctional zone in comparison to PSF (1-level: 0.529 and 2-level: 0.421). This linearity was similar to the compared techniques (TPH and Tape2). CONCLUSION: The Cable Anchor System presented in this study demonstrated a gradual ROM transition zone at the proximal end of a rigid pedicle screw construct similar to TPH and 2-level sublaminar tape semi-rigid junctional fixation constructs, while providing the benefit of preserving the posterior ligament complex.Level of Evidence: 5.

Biomechanical comparison of semirigid junctional fixation techniques to prevent proximal junctional failure after thoracolumbar adult spinal deformity correction.

BACKGROUND CONTEXT: Adult spinal deformity patients treated operatively by long-segment instrumented spinal fusion are prone to develop proximal junctional kyphosis (PJK) and failure (PJF). A gradual transition in range of motion (ROM) at the proximal end of spinal instrumentation may reduce the incidence of PJK and PJF, however, previously evaluated techniques have not directly been compared. PURPOSE: To determine the biomechanical characteristics of five different posterior spinal instrumentation techniques to achieve semirigid junctional fixation, or "topping-off," between the rigid pedicle screw fixation (PSF) and the proximal uninstrumented spine. STUDY DESIGN: Biomechanical cadaveric study. METHODS: Seven fresh-frozen human cadaveric spine segments (T8-L3) were subjected to ex vivo pure moment loading in flexion-extension, lateral bending and axial rotation up to 5 Nm. The native condition, three-level PSF (T11-L2), PSF with supplemental transverse process hooks at T10 (TPH), and two sublaminar taping techniques (knotted and clamped) as one- (T10) or two-level (T9, T10) semirigid junctional fixation techniques were compared. The ROM and neutral zone (NZ) of the segments were normalized to the native condition. The linearity of the transition zones over three or four segments was determined through linear regression analysis. RESULTS: All techniques achieved a significantly reduced ROM at T10-T11 in flexion-extension and axial rotation relative to the PSF condition. Additionally, both two-level sublaminar taping techniques (CT2, KT2) had a significantly reduced ROM at T9-T10. One-level clamped sublaminar tape (CT1) had a significantly lower ROM and NZ compared with one-level knotted sublaminar tape (KT1) at T10-T11. Linear regression analysis showed the highest linear correlation between ROM and vertebral level for TPH and the lowest linear correlation for CT2. CONCLUSIONS: All studied semirigid junctional fixation techniques significantly reduced the ROM at the junctional levels and thus provide a more gradual transition than pedicle screws. TPH achieves the most linear transition over three vertebrae, whereas KT2 achieves that over four vertebrae. In contrast, CT2 effectively is a one-level semirigid junctional fixation technique with a shift in the upper rigid fixation level. Clamped sublaminar tape reduces the NZ greatly, whereas knotted sublaminar tape and TPH maintain a more physiologic NZ. Clinical validation is ultimately required to translate the biomechanics of various semirigid junctional fixation techniques into the clinical goal of reducing the incidence of proximal junctional kyphosis and failure. CLINICAL SIGNIFICANCE: The direct biomechanical comparison of multiple instrumentation techniques that aim to reduce the incidence of PJK after thoracolumbar spinal fusion surgery provides a basis upon which clinical studies could be designed. Furthermore, the data provided in this study can be used to further analyze the biomechanical effects of the studied techniques using finite element models to better predict their post-operative effectiveness.

Instrumentation techniques to prevent proximal junctional kyphosis and proximal junctional failure in adult spinal deformity correction-a systematic review of biomechanical studies.

BACKGROUND CONTEXT: Correction of adult spinal deformity (ASD) by long segment instrumented spinal fusion is an increasingly common surgical intervention. However, it is associated with high rates of complications and revision surgery, especially in the elderly patient population. The high construct stiffness of instrumented thoracolumbar spinal fusion has been postulated to lead to a higher incidence of proximal junctional kyphosis (PJK) and failure (PJF). Several cadaveric biomechanical studies have reported on surgical techniques to reduce the incidence of PJF/PJK. As yet, no overview has been made of these biomechanical studies. PURPOSE: To summarize the evidence of all biomechanical studies that have assessed techniques to reduce PJK/PJF following long segment instrumented spinal fusion in the ASD patient population. STUDY DESIGN: A systematic review. METHODS: EMBASE and MEDLINE databases were searched for human and animal cadaveric biomechanical studies investigating the effect of various surgical techniques to reduce PJK/PJF following long segment instrumented thoracolumbar spinal fusion in the adult patient population. Studied techniques, biomechanical test methods, range of motion (ROM), intervertebral disc pressure (IDP) and other relevant outcome parameters were documented. RESULTS: Twelve studies met the inclusion criteria. Four of these studies included non-human cadaveric material. One study investigated the prophylactic application of cement augmentation (vertebroplasty), whereas the remaining studies investigated semi-rigid junctional fixation techniques to achieve a gradual transition zone of forces at the proximal end of a fusion construct, so-called topping-off. An increased gradual transition zone in terms of ROM compared to pedicle screw constructs was demonstrated for sublaminar tethers, sublaminar tape, pretensioned suture loops, transverse hooks and laminar hooks. Furthermore, reduced IDP was found after the application of sublaminar tethers, suture loops, sublaminar tapes and laminar hooks. Finally, two-level prophylactic vertebroplasty resulted in a lower incidence of vertebral compression fractures in a flexion-compression experiment. CONCLUSIONS: A variety of techniques, involving either posterior semi-rigid junctional fixation or the reinforcement of vertebral bodies, has been biomechanically assessed. However, the low number of studies and variation in study protocols hampers direct comparison of different techniques. Furthermore, determination of what constitutes an optimal gradual transition zone and its translation to clinical practice, would aid comparison and further development of different semi-rigid junctional fixation techniques. Even though biomechanics are extremely important in the development of PJK/PJF, patient-specific factors should always be taken into account on a case-by-case basis when considering to apply a semi-rigid junctional fixation technique.

Ultra-high-molecular-weight polyethylene sublaminar tape as semirigid fixation or pedicle screw augmentation to prevent failure in long-segment spine surgery: an ex vivo biomechanical study.

OBJECTIVE: Complications after adult spinal deformity surgery are common, with implant-related complications occurring in up to 27.8% of cases. Sublaminar wire fixation strength is less affected by decreasing trabecular bone density in comparison to pedicle screw (PS) fixation due to the predominant cortical bone composition of the lamina. Sublaminar fixation may thus aid in decreasing implant-related complications. The goal of this study was to compare fixation characteristics of titanium sublaminar cables (SCs), ultra-high-molecular-weight polyethylene (UHMWPE) tape, PSs, and PSs augmented with UHMWPE tape in an ex vivo flexion-bending setup. METHODS: Thirty-six human cadaver vertebrae were stratified into 4 different fixation groups: UHMWPE sublaminar tape (ST), PS, metal SC, and PS augmented with ST (PS + ST). Individual vertebrae were embedded in resin, and a flexion-bending moment was applied that closely resembles the in vivo loading pattern at transitional levels of spinal instrumentation. RESULTS: The failure strength of PS + ST (4522 ± 2314 N) was significantly higher compared to the SC (2931 ± 751 N) and PS (2678 ± 827 N) groups, which had p values of 0.028 and 0.015, respectively (all values expressed as the mean ± SD). Construct stiffness was significantly higher for the PS groups compared to the stand-alone sublaminar wiring groups (p = 0.020). In contrast to SC, ST did not show any case of cortical breach. CONCLUSIONS: The higher failure strength of PS + ST compared to PS indicates that PS augmentation with ST may be an effective measure to reduce the incidence of screw pullout, even in osteoporotic vertebrae. Moreover, the lower stiffness of sublaminar fixation techniques and the absence of damage to the cortices in the ST group suggest that ST as a stand-alone fixation technique in adult spinal deformity surgery may also be clinically feasible and offer clinical benefits.