Getting PEEK to Stick to Bone: The Development of Porous PEEK for Interbody Fusion Devices.

Interbody fusion cages are routinely implanted during spinal fusion procedures to facilitate arthrodesis of a degenerated or unstable vertebral segment. Current cages are most commonly made from polyether-ether-ketone (PEEK) due to its favorable mechanical properties and imaging characteristics. However, the smooth surface of current PEEK cages may limit implant osseointegration and may inhibit successful fusion. We present the development and clinical application of the first commercially available porous PEEK fusion cage (COHERE®, Vertera, Inc., Atlanta, GA) that aims to enhance PEEK osseointegration and spinal fusion outcomes. The porous PEEK structure is extruded directly from the underlying solid and mimics the structural and mechanical properties of trabecular bone to support bone ingrowth and implant fixation. Biomechanical testing of the COHERE® device has demonstrated greater expulsion resistance versus smooth PEEK cages with ridges and greater adhesion strength of porous PEEK versus plasma-sprayed titanium coated PEEK surfaces. In vitro experiments have shown favorable cell attachment to porous PEEK and greater proliferation and mineralization of cell cultures grown on porous PEEK versus smooth PEEK and smooth titanium surfaces, suggesting that the porous structure enhances bone formation at the cellular level. At the implant level, preclinical animal studies have found comparable bone ingrowth into porous PEEK as those previously reported for porous titanium, leading to twice the fixation strength of smooth PEEK implants. Finally, two clinical case studies are presented demonstrating the effectiveness of the COHERE® device in cervical spinal fusion.

Intraoperative biomechanics of lumbar pedicle screw loosening following successful arthrodesis.

Pedicle screw loosening has been implicated in recurrent back pain after lumbar spinal fusion, but the degree of loosening has not been systematically quantified in patients. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. Here, we quantified pedicle screw loosening by measuring screw insertion and/or removal torque at high statistical power (beta = 0.02) in N = 108 patients who experienced pain recurrence despite successful fusion after posterior instrumented lumbar fusion with anterior lumbar interbody fusion (L2-S1). Between implantation and removal, pedicle screw torque was reduced by 58%, indicating significant loosening over time. Loosening was greater in screws with evoked EMG threshold under 11 mA, indicative of screw misplacement. A theoretical stress analysis revealed increased local stresses at the screw interface in pedicles with decreased difference in pedicle thickness and screw diameter. Loosening was greatest in vertebrae at the extremities of the fused segments, but was significantly lower in segments with one level of fusion than in those with two or more. CLINICAL SIGNIFICANCE: These data indicate that pedicle screws can loosen significantly in patients with recurrent back pain and warrant further research into methods to reduce the incidence of screw loosening and to understand the risks and potential benefits of instrumentation removal. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:2673-2681, 2017.

Anterior lumbar interbody fusion: two-year results with a modular interbody device.

STUDY DESIGN: Retrospective case series. PURPOSE: To present radiographic outcomes following anterior lumbar interbody fusion (ALIF) utilizing a modular interbody device. OVERVIEW OF LITERATURE: Though multiple anterior lumbar interbody techniques have proven successful in promoting bony fusion, postoperative subsidence remains a frequently reported phenomenon. METHODS: Forty-three consecutive patients underwent ALIF with (n=30) or without (n=11) supplemental instrumentation. Two patients underwent ALIF to treat failed posterior instrumented fusion. The primary outcome measure was presence of fusion as assessed by computed tomography. Secondary outcome measures were lordosis, intervertebral lordotic angle (ILA), disc height, subsidence, Bridwell fusion grade, technical complications and pain score. Interobserver reliability of radiographic outcome measures was calculated. RESULTS: Forty-three patients underwent ALIF of 73 motion segments. ILA and disc height increased over baseline, and this persisted through final follow-up (p<0.01). Solid anterior interbody fusion was present in 71 of 73 motion segments (97%). The amount of new bone formation in the interbody space increased over serial imaging. Subsidence >4 mm occurred in 12% of patients. There were eight surgical complications (19%): one major (reoperation for nonunion/progressive subsidence) and seven minor (five subsidence, two malposition). CONCLUSIONS: The use of a modular interbody device for ALIF resulted in a high rate of radiographic fusion and a low rate of subsidence. The large endplate and modular design of the device may contribute to a low rate of subsidence as well as maintenance of ILA and lordosis. Previously reported quantitative radiographic outcome measures were found to be more reliable than qualitative or categorical measures.

Biomechanical evaluation of a novel fenestrated pedicle screw augmented with bone cement in osteoporotic spines.

STUDY DESIGN: Comparative biomechanical study was conducted in osteoporotic human cadaveric spines. OBJECTIVE: Determine the influence of the volume of polymethyl methacrylate injected through a fenestrated pedicle screw on the pullout strength and on the ability to safely remove the implant. SUMMARY OF BACKGROUND DATA: Pedicle screw fixation in the osteoporotic spine can be improved by the addition of bone cement. Various injection techniques have been used. While improvement has been shown for the pullout strength, the optimal volume of cement to inject has not been previously studied. METHODS: Seven osteoporotic spines were instrumented with a standard and a fenestrated pedicle screw augmented with polymethyl methacrylate at each level (T7-L5). Three volumes of bone cement were randomly injected and stratified to the thoracic (0.5 cc, 1.0 cc, and 1.5 cc) and lumbar spine (1.5 cc, 2.0 cc, and 2.5 cc). Axial pullout strength and removal torque of the pedicle screws were quantified. RESULTS: The pullout strength of the fenestrated screw was normalized with respect to its contralateral control. Student paired t tests were conducted and a statistically significant increase was noted for 1.0 cc (186 ± 45%) and 1.5 cc (158 ± 46%) in the thoracic spine and for 1.5 cc (264 ± 193%), 2.0 cc (221 ± 93%), and 2.5 cc (198 ± 42%) in the lumbar spine. There was no significant difference with higher volumes of cement. The median removal torque was 0.34 Nm for the standard and 1.83 Nm for the augmented screws. When the augmented implants were removed, the bone cement sheared completely off at the fenestrations in 15 of the 17 cases. CONCLUSION: Significant increases in pullout strength can be accomplished by injecting a limited quantity of bone cement through a fenestrated screw while minimizing the risks associated with higher volume. The majority of implants were removed without damaging the vertebra as the bone cement sheared off at the fenestrations.

Interbody device endplate engagement effects on motion segment biomechanics.

BACKGROUND CONTEXT: Stand-alone nonbiologic interbody fusion devices for the lumbar spine have been used for interbody fusion since the early 1990s. However, most devices lack the stability found in clinically successful circumferential fusion constructs. Stability results from cage geometry and device/vertebral endplate interface integrity. To date, there has not been a published comparative biomechanical study specifically evaluating the effects of endplate engagement of interbody devices. PURPOSE: Lumbar motion segments implanted with three different interbody devices were tested biomechanically to compare the effects of endplate engagement on motion segment rigidity. The degree of additional effect of supplemental posterior and anterior fixation was also investigated. STUDY DESIGN/SETTING: A cadaveric study of interbody fusion devices with varying degrees of endplate interdigitation. OUTCOME MEASURES: Implanted motion segment range of motion (ROM), neutral zone (NZ), stiffness, and disc height. METHODS: Eighteen human L23 and L45 motion segments were distributed into three interbody groups (n=6 each) receiving a polymeric (polyetheretherketone) interbody spacer with small ridges; a modular interbody device with endplate spikes (InFix, Abbott Spine, Austin, TX, USA); or dual tapered threaded interbody cages (LT [Lordotic tapered] cage; Medtronic, Memphis, TN, USA). Specimens were tested intact using a 7.5-Nm flexion-extension, lateral bending, and axial torsion flexibility protocol. Testing was repeated after implantation of the interbody device, anterior plate fixation, and posterior interpedicular fixation. Radiographic measurements determined changes in disc height and intervertebral lordosis. ROM and NZ were calculated and compared using analysis of variance. RESULTS: The interbody cages with endplate spikes or threads provided a statistically greater increase in disc height versus the polymer spacer (p=.01). Relative to intact, all stand-alone devices significantly reduced ROM in lateral bending by a mean 37% to 61% (p< or =.001). The cages with endplate spikes or threads reduced ROM by approximately 50% and NZ by approximately 60% in flexion-extension (p< or =.02). Only the cage with endplate spikes provided a statistically significant reduction in axial torsion ROM compared with the intact state (50% decrease, p<.001). Posterior fixation provided a significant reduction in ROM in all directions versus the interbody device alone (p<.001). Anterior plating decreased ROM over interbody device alone in flexion-extension and torsion but did not have additional effect on lateral bending ROM. CONCLUSION: The cages with endplate spikes or threads provide substantial motion segment rigidity compared with intact in bending modes. Only the cages with endplate spikes were more rigid than intact in torsion. All devices experienced increased rigidity with anterior plating and even greater rigidity with posterior fixation. It appears that the endplate engagement with spikes may be beneficial in limiting torsion, which is generally difficult with other "stand-alone" devices tested in the current and prior reports.

Using intraoperative electrophysiologic monitoring as a diagnostic tool for determining levels to decompress in the cervical spine: a case report.

OBJECTIVE: This report describes the clinical usefulness of using intraoperative electrophysiologic monitoring as a diagnostic tool for determining levels to decompress in the cervical spine. METHODS: A 59-year-old man was experiencing intractable neck and left upper extremity pain after sustaining a second spinal injury. (The patient had previously undergone an anterior cervical discectomy and fusion at C5-C6 with plating to treat injuries from a motor vehicle accident.) On examination, he had no motor changes but did have pain in his left upper extremity and numbness of the left thumb and index finger. A myelogram and postmyelogram computed tomography scan revealed a disc herniation at C4-C5 with severe neural foraminal disease on the left side of C4-C5 and residual posterior osteophytes with questionable neuroforaminal stenosis on the left side of C5-C6. Routine electrophysiologic studies showed mild irritation of the left biceps (left C5-C6 nerve root), indicating radiculopathy. The patient was admitted with plans to undergo plate removal, exploration of the fusion at C5-C6, and an anterior cervical discectomy with foraminotomies and fusion at C4-C5. Continuous free-running electromyography was recorded during the surgical procedures. RESULTS: The surgery was performed as planned; however, the irritation observed at C5-C6 did not subside. Relying on this information, as an extension of the patient's history and physical examination, a decision was made to remove the previous fusion at C5-C6 and to explore the left C6 root. A very tight neural foramen was found at this level. After decompression and foraminotomy, no electrophysiologic activity above baseline was recorded at C5-C6. The patient was then fused and plated from C4 to C6, and awoke with no left upper extremity pain. Neurologic examination was normal immediately after surgery and at 3 months follow-up. CONCLUSIONS: Intraoperative, continuous free-running electromyography proved clinically effective in determining the course of surgery.