SAS journal最新文献

Study design: This study is a systematic review of published biomechanical studies involving pedicle screw-based posterior dynamic stabilization devices (PDS) with a special focus on kinematics and load transmission through the functional spine unit (FSU).

Methods: A literature search was performed via the PubMed online database from 1990 to 2008 using the following key words: "biomechanics," "lumbar dynamic stabilization," "Graf system," "Dynesys," and "posterior dynamic implant." Citations were limited to papers describing biomechanics of pedicle screw-based PDS devices currently available for clinical use. Studies describing clinical experience, radiology, and in vivo testing were excluded from the review. Parameters measured included kinematics of the FSU (range of motion (ROM), neutral zone (NZ), and location of the center of rotation) and load transmission through the disk, facets, and instrumentation.

Results: A total of 27 publications were found that concerned the biomechanical evaluation of lumbar pedicle screw-based dynamic stabilization instrumentation. Nine in vitro experimental studies and 4 finite element analyses satisfied the inclusion criteria. The Dynesys implant was the most investigated pedicle screw-based PDS system. In vitro cadaveric studies mainly focused on kinematics comparing ROM of intact versus instrumented spines whereas finite element analyses allowed analysis of load transmission at the instrumented and adjacent levels.

Conclusion: Biomechanical studies demonstrate that pedicle screw-based PDS devices limit intervertebral motion while unloading the intervertebral disk. The implant design and the surgical technique have a significant impact on the biomechanical behavior of the instrumented spinal segment. The posterior placement of such devices results in non-physiologic intervertebral kinematics with a posterior shift of the axis of rotation. Biomechanical studies suggest that the difference at the adjacent level between investigated dynamic devices and rigid stabilization systems may not be as high as reported. Finally, additional investigations of semirigid devices are needed to further evaluate their biomechanical properties compared to soft stabilization PDS systems.

Background: The increasing complexity of articulating spinal implants prohibits the use of serum-supplemented simulator fluid testing because multicomponent interfaces retain residual protein and preclude gravimetric measurement. Our original hypothesis was that simulator testing of a posterior dynamic stabilization implant that has metal-on-metal articulating bearings will not produce dramatically different wear debris when tested using pure saline versus testing in saline supplemented with 20% serum.

Methods: This hypothesis was tested using simulator testing of 12 dynamic stabilization spinal implants, 6 in 100% saline and 6 in 20%-serum saline. Gravimetric and particle analysis were performed after every million cycles up to 10 million cycles, with flexion of 11.3°/extension of 5.6° coupled with axial rotation of ± 4°.

Results: The mean gravimetric weight loss was approximately 200 mg over 10 million cycles for the implants tested in 100% saline, while the mean weight loss for those tested in 20%-serum saline was below the method detection limits (< 10 mg over 10 million cycles). For the 100%-saline and 20%-serum simulator fluids, the average particle size over the course of 0 to 10 million cycles remained relatively constant at 0.2 µm-dia (saline) and 3.2 µm-dia (20%-serum saline). Testing in 100% saline generated > 1000-fold more particles, compared to testing in 20% serum-supplemented saline. Energy-dispersive X-ray (EDAX) analyses of particles demonstrated that the 100% saline debris was composed of Co-Cr-P-O (Cr-Co metal oxides), and for the 20%-serum saline debris only bulk metal Co-Cr was detected.

Conclusion: Our initial hypothesis was not supported. There were significant differences in gravimetric wear, average size, and type of wear debris that were mechanistically attributable to the type of simulator fluid used. The over-protective effect of serum proteins appears to underscore the importance of using both saline and serum when establishing upper and lower bounds of predictive implant debris generation modeling, where saline represents a worst-case scenario and as little as 20% serum masks all weight loss completely in highly modular articulating implants.

Clinical relevance: Clinical Relevance = 5 (Oxford Centre for Evidence-based Medicine Levels of Evidence). Study findings are limited to a greater understanding of the science associated with predictive wear testing of articulating spinal implants.

Background: Computer-assisted spinal navigation allows for real time localization of surgical instruments in multiple views. Its use decreases radiation exposure and clears the surgical field of the C-arm fluoroscope. Despite these advantages, spinal navigation has yet to gain general acceptance among spine surgeons. The purpose of this study is to survey spine surgeons about their opinions on the strengths and weaknesses of spinal navigation.

Methods: Spine surgeons from the membership of the Spine Arthroplasty Society (SAS) and the Society for Minimally Invasive Spine Surgery (SMISS) were surveyed regarding their current use of spinal navigation and their perceptions of the strengths and weaknesses of spinal navigation (N = 147). Responses were analyzed using 2-sided chi-square tests.

Results: Most spine surgeons (63.4%) have only superficial experience with spinal navigation, and 76.2% of surgeons rarely use spinal navigation in their cases. Spine surgeons have the most experience with virtual fluoroscopy spinal navigation systems (35.9%). Surgeons considered longer operating times (63.5%), increased cost (48.3%), lack of necessity (40.7%), unreliable navigation accuracy (37.9%), and too many intraoperative glitches (35.2%) to be the major weaknesses of spinal navigation. Surgeons considered decreased radiation exposure to the surgeon (76.1%), increased screw placement accuracy (65.7%), decreased radiation exposure to the patient (41.8%), and keeping the C-arm away from the operating field (29.1%) to be the greatest advantages of spinal navigation. Among the types of procedures surgeons believe are most likely to benefit from spinal navigation are minimally invasive instrumentation and fusion (72.5%) and complex open deformity (55.6%).

Conclusion: Most spine surgeons have only superficial experience in spinal navigation. The most commonly selected weaknesses of spinal navigation are increased operative time, cost, and lack of necessity. Increased fluoroscopy and MIS use in the future may shift focus from weaknesses to the strengths of spinal navigation, including decreased radiation exposure and elimination of the C-arm from the operative field.

Background: Prosthetic replacement of spinal discs is emerging as a treatment option for degenerative disc disease. Posterior dynamic transpedicular stabilization (PDTS) and prosthetic disc nucleus (PDN) devices have been used sporadically in spinal surgery.

Methods: This was a prospective study of 13 patients averaging 40.9 years of age with degenerative disc disease who underwent posterior placement of a PDN with a PDTS. The Oswestry low-back pain disability questionnaire and visual analog scale (VAS) for pain were used to assess patient outcomes at the 3rd, 6th, and 12th postoperative months. Lumbar range of motion was evaluated using a bubble inclinometer preoperatively and at 12 months postoperatively. Radiological parameters including lumbar lordosis angle (LL), segmental lordosis angle (α), disc height at the operated level (DHo), and disc height of the adjacent level (DHu) were evaluated. A typical midline posterior approach for complete discectomy was followed by the simultaneous placement of the PDN with PDTS.

Results: Both the Oswestry and VAS scores showed significant improvement postoperatively (P < .05). There were no significant differences in LL, α, DHo, and DHu parameters. We observed complications in 3 patients including 2 patients who had the PDN device embedded into the adjacent corpus; 1 had massive endplate degeneration, and the other experienced interbody space infection. In 1 patient, the PDN device migrated to one side in the vertebral space.

Conclusion: The use of a PDN in combination with posterior dynamic instrumentation can help to restore the physiologic motion of the anterior and posterior column and could help to establish posterior dynamic instrumentation as an important treatment of degenerative disc disease. Theoretically this concept is superior, but practically we need more advanced technology to replace disc material. Because this study examined the combination of the PDN and stabilization instrumention, the results cannot be compared with those reported in the literature for either PDN alone or dynamic screws alone.

Level of evidence: Prospective cohort study with good follow-up (level 1b).

Background: Fusion has been the traditional surgery for painful disc degeneration unresponsive to nonoperative care. Fusion rates may decline in multilevel procedures. Also, fusion may force additional stress onto adjacent discs. This effect may be amplified in multilevel procedures. Single-level total disc replacement (TDR) has been found to be as effective as fusion. There have been few published reports addressing 2-level TDR. The purpose of this study was to compare results of TDR at 2 levels to 1-level procedures.

Methods: This report included the first consecutive 86 patients who had reached 24-month follow-up from among those enrolled in the ProDisc-L investigational device exemption (IDE) study of patients undergoing TDR at 1 level (N = 54) or at 2 levels (N = 32). Clinical outcome measures included visual analog scales (VAS) assessing pain, Oswestry Disability Index, satisfaction measured by VAS, and responses to the question regarding whether the patient would have the same surgery again.

Results: Operative time and length of hospitalization were significantly less in the 1-level cases compared to 2 levels (61.6 min vs 97.8 min; and 1.89 days vs 2.44 days; P < .05). There was a trend for less blood loss in single-level cases (59.0 mL vs 79.2 mL) (.05 < P < .09). VAS and Oswestry scores were significantly improved in both groups postoperatively (by approximately 50%). At no follow-up were there significant differences in VAS, Oswestry, or patient satisfaction scores between the single- and 2-level patients. At all follow-ups, the mean satisfaction in both groups was greater than 7.5 on a scale of 0 to 10.

Conclusions: Patients undergoing 2-level TDR improved significantly postoperatively based on VAS and Oswestry scores, and there were no significant differences in outcome scores when comparing 1- and 2-level TDR.

Clinical relevance: This study suggests that 2-level TDR can be undertaken in appropriately selected patients and achieve results similar to singlelevel cases.