Biomechanical Stability of a Stand-Alone Interbody Spacer in Two-Level and Hybrid Cervical Fusion Constructs.

STUDY DESIGN: In vitro human cadaveric biomechanical analysis. OBJECTIVE: To evaluate the segmental stability of a stand-alone spacer (SAS) device compared with the traditional anterior cervical plate (ACP) construct in the setting of a 2-level cervical fusion construct or as a hybrid construct adjacent to a previous 1-level ACP construct. METHODS: Twelve human cadaveric cervical spines (C2-T1) were nondestructively tested with a custom 6-degree-of-freedom spine simulator under axial rotation (AR), flexion-extension (FE), and lateral bending (LB) at 1.5 N m loads. After intact analysis, each specimen underwent instrumentation and testing in the following 3 configurations, with each specimen randomized to the order of construct: (A) C5-7 SAS; (B) C5-6 ACP, and C6-7 SAS (hybrid); (C) C5-7 ACP. Full range of motion (ROM) data at C5-C7 was obtained and analyzed by each loading modality utilizing mean comparisons with repeated measures analysis of variance with Sidak correction for multiple comparisons. RESULTS: Compared with the intact specimen, all tested constructs had significantly increased segmental stability at C5-C7 in AR and FE ROM, with no difference in LB ROM. At C5-C6, all test constructs again had increased segmental stability in FE ROM compared with intact (10.9° ± 4.4° Intact vs SAS 6.6° ± 3.2°, P < .001; vs.Hybrid 2.9° ± 2.0°, P = .005; vs ACP 2.1° ± 1.4°, P < .001), but had no difference in AR and LB ROM. Analysis of C6-C7 ROM demonstrated all test groups had significantly greater segmental stability in FE ROM compared with intact (9.6° ± 2.7° Intact vs SAS 5.0° ± 3.0°, P = .018; vs Hybrid 5.0° ± 2.7°, P = .018; vs ACP 4.4° ± 5.2°, P = .005). Only the hybrid and 2-level ACP constructs had increased stability at C6-C7 in AR ROM compared with intact, with no difference for all test groups in LB ROM. Comparison between test constructs demonstrated no difference in C5-C7 and C6-C7 segmental stability in all planes of motion. However, at C5-C6 comparison between test constructs found the 2-level SAS had significantly less segmental stability compared to the hybrid (6.6° ± 3.2° vs 2.9° ± 2.0°, P = .025) and ACP (6.6° ± 3.2° vs 2.1° ± 1.4°, P = .004). CONCLUSIONS: Our study found the currently tested SAS device may be a reasonable option as part of a 2-level hybrid construct, when used below an adjacent 1-level ACP, but should be used with careful consideration as a 2-level SAS construct. Consequences of decreased segmental stability in FE are unknown; however, optimal immediate fixation stability is an important surgical principle to avoid loss of fixation, segmental kyphosis, interbody graft subsidence, and pseudarthrosis.

Effects of rod reduction on pedicle screw fixation strength in the setting of Ponte osteotomies.

BACKGROUND CONTEXT: The use of a rod reduction device can have deleterious consequences on pedicle screw pullout strength (POS) in the thoracic spine. However, posterior-only osteotomies in the thoracic spine are often performed to improve flexibility of the spine and offset forces of deformity correction maneuvers. PURPOSE: To investigate the effect on pedicle screw POS caused by the rod reduction technique in the presence of facet osteotomies in the thoracic spine. STUDY DESIGN/SETTING: The study is a biomechanical study using human cadaveric spine specimens. METHODS: Thoracic Ponte osteotomies were performed on 3 thoracic levels in 15 cadaveric specimens. The right rod was contoured with a 5-mm residual gap at the middle level and was reduced using a rod reduction device. On the left side (paired control), a rod with no mismatch was placed. Biomechanical testing was performed with tensile load to failure "in line" with the screw axis and POS measured in Newtons (N). RESULTS: After rod reduction, thoracic pedicle screw POS was significantly decreased (40%) compared with the control (419±426 N vs. 708±462 N, p=.002) and remained statistically significant after adjusting for bone mineral density (BMD) (p=.05). Eleven (73%) of the pedicle screws had visible pullout/failure during the reduction attempt and occurred irrespective of BMD. CONCLUSIONS: Despite thoracic Ponte osteotomies and increased flexibility of the spinal segments, the rod reduction device still significantly decreased pedicle screw POS, typically resulting in outright failure of the screw-bone interface. Therefore, rod reduction technique of any kind should be performed with caution as it frequently results in suboptimal pedicle screw fixation.

Pedicle screw reinsertion using previous pilot hole and trajectory does not reduce fixation strength.

STUDY DESIGN: Fresh-frozen human cadaveric biomechanical study. OBJECTIVE: To evaluate the biomechanical consequence of pedicle screw reinsertion in the thoracic spine. SUMMARY OF BACKGROUND DATA: During pedicle screw instrumentation, abnormal appearance on fluoroscopic imaging or low current reading with intraoperatively evoked electromyographic stimulation of a pedicle screw warrants complete removal to reassess for pedicle wall violation or screw malposition. However, screw fixation strength has never been evaluated biomechanically after reinsertion using a previous pilot hole and trajectory. METHODS: Thirty-one thoracic individual fresh-frozen human cadaveric vertebral levels were instrumented bilaterally with 5.5-mm titanium polyaxial pedicle screws, and insertional torque (IT) was measured with each revolution. A paired comparison was performed for each level. Screw reinsertion was performed by completely removing the pedicle screw, palpating the tract, and then reinserting along the same trajectory. Screws were tensile loaded to failure "in-line" with the screw axis. RESULTS: There was no significant difference for pedicle screw pullout strength (POS) between reinserted and control screws (732 ± 307 N vs. 742 ± 320 N, respectively; P = 0.78). There was no significant difference in IT between initial insertion for the test group (INI) (0.82 ± 0.40 N·m) and control (0.87 ± 0.50 N·m) (P = 0.33). IT for reinserted screws (0.58 ± 0.47 N·m) had significantly decreased compared with INI and control screws (29% decrease, P = 0.00; 33% decrease, P = 0.00, respectively). The test group screws in the thoracic spine had significant correlations between initial IT and POS (r = 0.79, P = 0.00), and moderate correlations between reinsertion IT and POS in the thoracic spine (r = 0.56, P = 0.00). CONCLUSION: Despite a significant reduction in pedicle screw IT, there was no significant difference in pedicle screw POS with reinsertion. Therefore, when surgeons must completely remove a pedicle screw for tract inspection, reinsertion along the same trajectory may be performed without significantly compromising fixation strength. LEVEL OF EVIDENCE: N/A.

Pedicle screw "hubbing" in the immature thoracic spine: a biomechanical and micro-computed tomography evaluation.

BACKGROUND: A previous biomechanical study using adult thoracic vertebrae (both normal and osteoporotic bone density) demonstrated the deleterious effect of the pedicle screw hubbing technique. Pedicle screw "hubbing" involves seating and engaging the ventral aspect of the screw head onto the dorsal lamina cortex. This technique is postulated to provide a load-sharing effect by improving pullout resistance, as well as decreasing cephalocaudad toggling and implant loosening. We hypothesized the elastic properties of immature bone may mitigate, and perhaps enhance the purported benefits of the hubbing technique. We set out to evaluate pullout strength of fixed-head pedicle screws after hubbing versus standard insertion in the immature thoracic calf spine. METHODS: Twenty-two (n=22) single-level disarticulated fresh-frozen immature calf thoracic vertebra specimens (ranging from T2 to T13) were prepared. Twelve specimens were instrumented with pedicle screws in group I (nonhubbed) and group II (hubbed) in the opposite pedicle. Cyclic loading in a cephalocaudad direction was applied for 2000 cycles at a rate of 1 Hz. Pullout testing was performed in-line with the midline of the vertebra and peak pullout strength was measured in Newtons. Ten different specimens underwent micro-computed tomography evaluation to assess for trabecular architecture and incidence of iatrogenic microfractures. RESULTS: Hubbed screws resulted in significantly lower pullout strength (747±197 vs. 922±112 N, P=0.01). With the hubbing technique, the dorsal cortex demonstrated plastic deformation and conformed to the screw head in 83% of cases compared with no visible plastic deformation in the control group. Micro-computed tomography demonstrated microfractures of the dorsal cortex in 10/10 for the hubbed group compared with 1/10 for the control group. CONCLUSIONS: This is the largest study ever performed on immature thoracic vertebra to evaluate this topic. Hubbed pedicle screws have significantly decreased pullout strength and frequently cause iatrogenic microfractures of the dorsal cortex. The unique ability of immature bone to exhibit plastic deformation did not provide a protective effect on immediate fixation strength, and the increased insertional torque during the hubbing technique should not give a false sense of added fixation. This study, along with our adult study, provides critical information to the surgeon to avoid this common misunderstanding with screw insertion technique. CLINICAL RELEVANCE: In vitro fresh-frozen immature calf spine study.

Do stand-alone interbody spacers with integrated screws provide adequate segmental stability for multilevel cervical arthrodesis?

BACKGROUND CONTEXT: Some postoperative complications after anterior cervical fusions have been attributed to anterior cervical plate (ACP) profiles and the necessary wide operative exposure for their insertion. Consequently, low-profile stand-alone interbody spacers with integrated screws (SIS) have been developed. Although SIS constructs have demonstrated similar biomechanical stability to the ACP in single-level fusions, their role as a stand-alone device in multilevel reconstructions has not been thoroughly evaluated. PURPOSE: To evaluate the acute segmental stability afforded by an SIS device compared with the traditional ACP in the setting of a multilevel cervical arthrodesis. STUDY DESIGN: In vitro human cadaveric biomechanical analysis. METHODS: Thirteen human cadaveric cervical spines (C2-T1) were nondestructively tested with a custom 6 df spine simulator under axial rotation, flexion-extension, and lateral bending loading. After intact analysis, eight single-levels (C4-C5/C6-C7) from four specimens were instrumented and tested with ACP and SIS. Nine specimens were tested with C5-C7 SIS, C5-C7 ACP, C4-C7 ACP, C4-C7 ACP+posterior fixation, C4-C7 SIS, and C4-C7 SIS+posterior fixation. Testing order was randomized with each additional level instrumented. Full range of motion (ROM) data were obtained and analyzed by each loading modality, using mean comparisons with repeated measures analysis of variance. Paired t tests were used for post hoc analysis with Sidak correction for multiple comparisons. RESULTS: No significant difference in ROM was noted between the ACP and SIS for single-level fixation (p>.05). For multisegment reconstructions (two and three levels), the ACP proved superior to SIS and intact condition, with significantly lower ROM in all planes (p<.05). When either the three-level SIS or ACP constructs were supplemented with posterior lateral mass fixation, there was a greater than 80% reduction in ROM under all testing modalities (p<.05), with no significant difference between the ACP and SIS constructs (p>.05). CONCLUSIONS: The SIS device may be a reasonable option as a stand-alone device for single-level fixation. However, SIS devices should be used with careful consideration in the setting of multilevel cervical fusion. However, when supplemented with posterior fixation, SIS devices are a sound biomechanical alternative to ACP for multilevel fusion constructs.

The ventral lamina and superior facet rule: a morphometric analysis for an ideal thoracic pedicle screw starting point.

BACKGROUND CONTEXT: With the increasing popularity of thoracic pedicle screws, the freehand technique has been espoused to be safe and effective. However, there is currently no objective, definable landmark to assist with freehand insertion of pedicle screws in the thoracic spine. With our own increasing surgical experience, we have noted a reproducible and unique anatomic structure known as the ventral lamina. PURPOSE: We set out to define the morphologic relationship of the ventral lamina to the superior articular facet (SAF) and pedicle, and describe an optimal medial-lateral pedicle screw starting point in the thoracic spine. STUDY DESIGN: We conducted an in vitro fresh-frozen human cadaveric study. METHODS: One hundred fifteen thoracic spine vertebral levels were evaluated. After the vertebral body was removed, Kirschner wires were inserted retrograde along the four boundaries of the pedicle. Using digital calipers, we measured width of the SAF and pedicle at the isthmus, and from the borders of the SAF to the boundaries of the pedicle. We calculated the morphologic relationship of the ventral lamina and the center of the pedicle (COP) to the SAF. RESULTS: Two hundred twenty-nine pedicles were measured, with one pedicle excluded because of fracture of the SAF during disarticulation. The ventral lamina was clearly identifiable at all levels, forming the roof of the spinal canal and confluent with the medial pedicle wall (MPW). The mean distance from the SAF midline to the MPW was 1.36±1.23 mm medial. The MPW was lateral to SAF midline in 34 pedicles (14.85%) and, on average, was a distance of 0.52±0.51 mm lateral. The mean distance from the SAF midline to the COP was 2.17±1.38 mm lateral. The COP was medial to SAF midline in only 11 pedicles (4.80%). CONCLUSIONS: The ventral lamina is an anatomically reproducible structure located consistently medial to the SAF midline (85%). We also found the COP consistently lateral to the SAF midline (95%). Based on these morphologic findings, the medial-lateral starting point for thoracic pedicle screws should be 2 to 3 mm lateral to the SAF midline (superior facet rule), allowing screw placement in the COP and avoiding penetration into the spinal canal.

The biomechanical consequences of rod reduction on pedicle screws: should it be avoided?

BACKGROUND CONTEXT: Rod contouring is frequently required to allow for appropriate alignment of pedicle screw-rod constructs. When residual mismatch is still present, a rod persuasion device is often used to achieve further rod reduction. Despite its popularity and widespread use, the biomechanical consequences of this technique have not been evaluated. PURPOSE: To evaluate the biomechanical fixation strength of pedicle screws after attempted reduction of a rod-pedicle screw mismatch using a rod persuasion device. METHODS: Fifteen 3-level, human cadaveric thoracic specimens were prepared and scanned for bone mineral density. Osteoporotic (n=6) and normal (n=9) specimens were instrumented with 5.0-mm-diameter pedicle screws; for each pair of comparison level tested, the bilateral screws were equal in length, and the screw length was determined by the thoracic level and size of the vertebra (35 to 45 mm). Titanium 5.5-mm rods were contoured and secured to the pedicle screws at the proximal and distal levels. For the middle segment, the rod on the right side was intentionally contoured to create a 5-mm residual gap between the inner bushing of the pedicle screw and the rod. A rod persuasion device was then used to engage the setscrew. The left side served as a control with perfect screw/rod alignment. After 30 minutes, constructs were disassembled and vertebrae individually potted. The implants were pulled in-line with the screw axis with peak pullout strength (POS) measured in Newton (N). For the proximal and distal segments, pedicle screws on the right side were taken out and reinserted through the same trajectory to simulate screw depth adjustment as an alternative to rod reduction. RESULTS: Pedicle screws reduced to the rod generated a 48% lower mean POS (495±379 N) relative to the controls (954±237 N) (p<.05) and significantly decreased work energy to failure (p<.05). Nearly half (n=7) of the pedicle screws had failed during the reduction attempt with visible pullout of the screw. After reduction, decreased POS was observed in both normal (p<.05) and osteoporotic (p<.05) bone. Back out and reinsertion of the screw resulted in no significant difference in mean POS, stiffness, and work energy to failure (p>.05). CONCLUSIONS: In circumstances where a rod is not fully seated within the pedicle screw, the use of a rod persuasion device decreases the overall POS and work energy to failure of the screw or results in outright failure. Further rod contouring or correction of pedicle screw depth of insertion may be warranted to allow for appropriate alignment of the longitudinal rods.

What is the best way to optimize thoracic kyphosis correction? A micro-CT and biomechanical analysis of pedicle morphology and screw failure.

STUDY DESIGN: A human cadaveric biomechanical analysis. OBJECTIVE: The purpose of this study was to evaluate the bone density/trabecular width of the thoracic pedicle and correlate that with its resistance against compressive loading used during correction maneuvers in the thoracic spine (i.e., cantilever bending). SUMMARY OF BACKGROUND DATA: As surgeons perform cantilever correction maneuvers in the spine, it is common to have pedicle screws pullout or displace while placing corrective forces on the construct. Currently, surgeons either compress against the cephalad aspect of the pedicle or vice versa. We set out to establish which aspect of the pedicle was the most dense and to determine the optimal direction for screw compression during kyphosis/deformity correction. METHODS: Fifteen fresh-frozen cadaveric vertebrae (n = 15) were examined by micro-computed tomography to determine percent bone volume/total volume (%BV/TV) within the cephalad and caudad aspects of the pedicle. Specimens were sectioned in the sagittal plane. Pedicles were instrumented according to the straightforward trajectory on both sides. Specimens were then mounted and loading to failure was performed perpendicular to the screw axis (either the cephalad or the caudad aspect of the pedicle). RESULTS: Mean failure when loading against the caudad aspect of the pedicle was statistically, significantly greater (454.5 ± 241.3 N vs. 334.79 1 ± 158.435 N) than for the cephalad pedicle (P < 0.001). In concordance with failure data, more trabecular and cortical bones were observed within the caudad half of the pedicle compared with the cephalad half (P < 0.001). CONCLUSION: Our results suggest that the caudad half of the pedicle is denser and withstands higher forces compared with the cephalad aspect. In turn, the incidence of intraoperative screw loosening and/or pedicle fracture may be reduced if the compressive forces (cantilever bending during deformity correction) placed upon the construct are applied against the caudad portion of the pedicle.

The biomechanical effect of pedicle screw hubbing on pullout resistance in the thoracic spine.

BACKGROUND CONTEXT: The biomechanical fixation strength afforded by pedicle screws has been strongly correlated with bone mineral density. It has been postulated that "hubbing" the head of the pedicle screw against the dorsal laminar cortex provides a load-sharing effect, thereby limiting cephalocaudad toggling and improving the pullout resistance of the pedicle screw. PURPOSE: To evaluate the pullout strength (POS) of monoaxial hubbed pedicle screws versus standard fixation in the thoracic spine. STUDY DESIGN: Biomechanical investigation. METHODS: Twenty-two human cadaveric thoracic vertebrae were acquired and dual-energy X-ray absorptiometry scanned. Osteoporotic (n = 16) and normal (n = 6) specimens were instrumented with a 5.0 × 35-mm pedicle screw on one side in a standard fashion. In the contralateral pedicle, 5.0 × 30-mm screw was inserted with hubbing of the screw into the dorsal lamina. A difference in screw length was used to achieve equivalent depth of insertion. After 2,000 cycles of cephalocaudad toggling, screws were pulled out with the tensile force oriented to the midline of the spine and peak POS measured in newtons (N). Four additional specimens were subjected to microcomputed tomography (micro-CT) analysis to evaluate internal pedicle architecture after screw insertion. RESULTS: Hubbed screws resulted in significantly lower POS (290.5 ± 142.4 N) compared with standard pedicle screws (511.5 ± 242.8 N; p = .00). This finding was evident in both normal and osteoporotic vertebrae based on independent subgroup post hoc analyses (p<.05). As a result of hubbing, half of the specimens fractured through the lamina or superior articular facet (SAF). No fractures occurred on the control side. There was no difference in mean POS for hubbed screws with and without fracture; however, further micro-CT analysis revealed the presence of internal fracture propagation for those specimens that did not have any external signs of failure. CONCLUSIONS: Hubbing pedicle screws results in significantly decreased POS compared with conventional pedicle screws. Hubbing predisposes toward iatrogenic fracture of the dorsal lamina, transverse process, or SAF during insertion.