Anthony Tsantrizos

Effect of implant design and endplate preparation on the compressive strength of interbody fusion constructs.

STUDY DESIGN A human cadaveric study on the compressive strength of different lumbar interbody fusion implants and endplate preparation techniques was performed. OBJECTIVES To assess the axial compressive strength of an implant with peripheral endplate contact as opposed to full surface contact, and to assess whether removal of the central bony endplate affects the axial compressive strength. SUMMARY OF BACKGROUND DATA The compressive strength of interbody fusion constructs has been compared between implants and bone grafts. Neither implant design nor endplate preparation has been shown to affect strength. Removal of the central bony endplate for bone grafts was noted to improve graft incorporation but also to facilitate subsidence. METHODS A total of 44 vertebrae were tested in four experimental groups by combining two interbody implants (full-surface vs peripheral surface support) with two endplate preparation techniques (intact bony endplate vs removal of the central bony endplate). Specimens were tested to ultimate compressive failure using a 50 N/second ramped load. Yield strength and ultimate compressive strength were compared between groups using two-factor analysis of covariance. A P value less than 0.05 was considered significant. Stepwise linear regressions assessed the predictive power of age, bone mineral content, and the implants normalized endplate coverage on yield strength and ultimate compressive strength. RESULTS Neither implant design nor endplate preparation technique affected yield strength or ultimate compressive strength. Age, bone mineral content, and the normalized endplate coverage were strong predictors of yield strength (P < 0. 0001; r2 = 0.459) and ultimate compressive strength (P < 0.0001; r2 = 0.510). CONCLUSIONS An implant with only peripheral support resting on the apophyseal ring offers axial mechanical strength similar to that of an implant with full support. Neither supplementary struts nor a solid implant face has any additional mechanical advantage, but reduces graft-host contact area. Removal of the central bony endplate is recommended because it does not affect the compressive strength and promotes graft incorporation.

Segmental Stability and Compressive Strength of Posterior Lumbar Interbody Fusion Implants

Study Design. Human cadaveric study on initial segmental stability and compressive strength of posterior lumbar interbody fusion implants. Objectives. To compare the initial segmental stability and compressive strength of a posterior lumbar interbody fusion construct using a new cortical bone spacer machined from allograft to that of titanium threaded and nonthreaded posterior lumbar interbody fusion cages, tested as stand-alone and with supplemental pedicle screw fixation. Summary of Background Data. Cages were introduced to overcome the limitations of conventional allografts. Radiodense cage materials impede radiographic assessment of the fusion, however, and may cause stress shielding of the graft. Methods. Multisegmental specimens were tested intact, with posterior lumbar interbody fusion implants inserted into the L4/L5 interbody space and with supplemental pedicle screw fixation. Three posterior lumbar interbody fusion implant constructs (Ray Threaded Fusion Cage, Contact Fusion Cage, and PLIF Allograft Spacer) were tested nondestructively in axial rotation, flexion–extension, and lateral bending. The implant–specimen constructs then were isolated and compressed to failure. Changes in the neutral zone, range of motion, yield strength, and ultimate compressive strength were analyzed. Results. None of the stand-alone implant constructs reduced the neutral zone. Supplemental pedicle screw fixation decreased the neutral zone in flexion–extension and lateral bending. Stand-alone implant constructs decreased the range of motion in flexion and lateral bending. Differences in the range of motion between stand-alone cage constructs were found in flexion and extension (marginally significant). Supplemental posterior fixation further decreased the range of motion in all loading directions with no differences between implant constructs. The Contact Fusion Cage and PLIF Allograft Spacer constructs had a higher ultimate compressive strength than the Ray Threaded Fusion Cage. Conclusions. The biomechanical data did not suggest any implant construct to behave superiorly either as a stand-alone or with supplemental posterior fixation. The PLIF Allograph Spacer is biomechanically equivalent to titanium cages but is devoid of the deficiencies associatedwith other cage technologies. Therefore, the PLIF Allograft Spacer is a valid alternative to conventional cages.

Cages: designs and concepts.

Abstract Many new interbody fusion cages have been recently developed, but clinical studies analyzing fusion outcome are still scarce. Radiological methods to assess fusion are not standardized and are often unreliable. Cages have been stated to provide good segmental distraction, provide axial load support and reduce segmental mobility, but there have been reports of failed fusions because of implant failure. This paper presents a critical opinion on current cage designs, stressing their clinical and biomechanical implications. Threaded cage designs compromise endplate integrity, and when placed in pairs have inherent limitations for distraction. Non-threaded cage designs usually preserve endplate integrity, but geometry may be inadequate to provide a good surface match to the endplate. The concept of an open frame type cage is believed to have biological advantages, because large graft volumes inside the cage can be in direct contact with host bone. Cadaveric tests suggest that open frame constructs have compressive strength similar to that of full surface contact cages. Restoration of segmental height, sagittal balance and increased neuroforaminal clearance are all functions of disc space distraction. The effect of cage instrumentation on axial load distribution, however, is not well understood. Biomechanical experiments strongly suggest supplementing cage instrumentation with posterior fixation, to achieve a marked increase in initial segmental stability. In the absence of gross segmental instability, micromotion at the host graft interface may still exist. As a result, fusion will never occur, instead a pseudoarthrosis will develop. For monitoring fusion, the use of non-metallic cages has distinct advantages, because no metal artifacts will disturb radiological assessment.

Biomechanical stability of five stand-alone anterior lumbar interbody fusion constructs

Abstract Anterior lumbar interbody fusion (ALIF) cages are expected to reduce segmental mobility. Current ALIF cages have different designs, suggesting differences in initial stability. The objective of this study was to compare the effect of different stand-alone ALIF cage constructs and cage-related features on initial segmental stability. Human multi-segmental specimens were tested intact and with an instrumented L3/4 disc level. Five different ALIF cages (I/F, BAK, TIS, SynCage, and ScrewCage) were tested non-destructively in axial rotation, flexion/extension and lateral bending. A cage ‘pull-out’ concluded testing. Changes in neutral zone (NZ) and range of motion (ROM) were analyzed. Cage-related measurements normalized to vertebral dimensions were used to predict NZ and ROM. No cage construct managed to reduce NZ. The BAK and TIS cages had the largest NZ increase in flexion/extension and lateral bending, respectively. Cages did reduce ROM in all loading directions. The TIS cage was the least effective in reducing the ROM in lateral bending. Cages with sharp teeth had higher ‘pull-out’ forces. Antero-posterior and medio-lateral cage dimensions, cage height and wedge angle were found to influence initial stability. The performance of stand-alone ALIF cage constructs generally increased the NZ in any loading direction, suggesting potential directions of initial segmental instability that may lead to permanent deformity. Differences between cages in flexion/extension and lateral bending NZ are attributed to the severity of geometrical cage-endplate surface mismatch. Stand-alone cage constructs reduced ROM effectively, but the residual ROM present indicates the presence of micromotion at the cage-endplate interface.

Internal Strains in Healthy and Degenerated Lumbar Intervertebral Discs

Study Design. A biomechanical study investigating the intradiscal mechanics of human lumbar intervertebral discs (IVDs). Objectives. To assess the relationship between nucleuspulposus migration and intradiscal strains as a function of degeneration. Summary of Background Data. Intradiscal deformation studies have documented the nucleus pulposus migration capabilities during bending but without assessing subsequent intradiscal strains of the anulus fibrosus. Degenerated IVDs show higher anular laxity, hypermobility, and, perhaps, segmental instability. It is unknown if nucleus pulposus migration might be the cause of increased intradiscal anular strains and if such a phenomenon is modulated by IVD degeneration. Methods. Eighteen healthy and degenerated IVDs were subjected to compression, extension, flexion, and lateral bending. Craniocaudal radiographs at unloaded and loaded steps documented positions of wires placed within and beads glued to the external surface in the mid-transverse plane. Circumferential and radial strains from the anterior, lateral, and posterolateral regions during load were compared between healthy and degenerated IVDs. Results. The nucleus pulposus migrated to the opposite side of bending regardless of bending direction and significantly more in degenerated IVDs. The highest nucleus pulposus migration was observed during lateral bending. Circumferential tensile strains were significantly higher in the posterolateral regions of degenerative IVDs during all loads. Degeneration significantly increased radial tensile and compressive strains during all bending loads. Conclusions. Increased nucleus pulposus migration in degenerated IVDs may result in increased shifting of the IVD pivot point during bending movements as well as intradiscal anular strains, particularly in the posterolateral anulus. This phenomenon may explain the segmental instability observed in degenerated segments as well as the associated anular tears present in the posterolateral region before IVD failure.

Nucleus Replacement With the DASCOR Disc Arthroplasty Device: Interim Two-Year Efficacy and Safety Results From Two Prospective, Non-Randomized Multicenter European Studies

Study Design. A prospective, nonrandomized multicenter study of lumbar disc nucleus replacement using the DASCOR Disc Arthroplasty Device. An interim analysis of clinical results is presented, obtained from European patients enrolled in 2 studies. Objective. To determine the safety and efficacy of the DASCOR Device for the treatment of symptomatic single-level degenerative disc disease (DDD). Summary of Background Data. Patients suffering from DDD have been limited to a choice between nonoperative therapies or invasive surgical treatments such as total disc replacement or spinal fusion. The DASCOR Device was developed to provide an alternative treatment with a less invasive surgical intervention. Methods. A total of 85 patients from 11 European centers were enrolled in 1 of 2 studies between February 2003 and July 31, 2007. Data were collected before surgery and after surgery at 6 weeks and at 3, 6, 12, and 24 months. The clinical outcome measures were obtained from the Visual Analog Scale (VAS) for back pain, the Oswestry Disability Index (ODI), radiographic assessments, and records of analgesic medication use. Results. Mean VAS and ODI scores improved significantly after 6 weeks and throughout the 2 years. Radiographic results demonstrated, at a minimum, maintenance of disc height with no device expulsion and, despite Modic-Type 1 changes, no subsidence. Fourteen patients had serious adverse events including device explants in 7 patients (7 of 85), in which the main complication was resumed back pain after time. Patients’ rate of analgesic medication decreased dramatically over time, with all patients experiencing significant improvements after 3 months and nearly no analgesic medication or narcotic drug use at 2 years. Conclusion. The interim outcomes showed significant improvements in mean ODI and VAS scores. The results of these European studies suggest that the DASCOR Device may be a safe and effective less-invasive surgical option for patients with DDD.

Mechanical and Biomechanical Characterization of a Polyurethane Nucleus Replacement Device Injected and Cured In Situ Within a Balloon

Background The DASCOR device has recently been introduced as an innovative nucleus replacement alternative for the treatment of low-back pain caused by degenerative intervertebral disc disease. The purpose of this study was to characterize, through a series of preclinical mechanical bench and biomechanical tests, the effectiveness of this device. Methods A number of samples were created using similar preparation methods in order to characterize the nucleus replacement device in multiple mechanical bench tests, using ASTM-guided protocols, where appropriate. Mechanical bench testing included static testing to characterize the devices compressive, shear properties, and fatigue testing to determine the devices compressive fatigue strength, wear, and durability. Biomechanical testing, using human cadaveric lumbar spines, was also conducted to determine the ability of the device to restore multidirectional segmental flexibility and to determine its resulting endplate contact stress. Results The static compressive and shear moduli of the nucleus replacement device were determined to be between 4.2–5.6 MPa and 1.4–1.9 MPa, respectively. Similarly, the ultimate compressive and shear strength were 12,400 N and 6,993 N, respectively. The maximum axial compressive fatigue strength of the tested device that was able to withstand a runout without failure was determined to be approximately 3 MPa. The wear assessment determined that the device is durable and yielded minimal wear rates of 0.29mg/Mc. Finally, the biomechanical testing demonstrated that the device can restore the multidirectional segmental flexibility to a level seen in the intact condition while concurrently producing a uniform endplate contact stress. Conclusions The results of the present study provided a mechanical justification supporting the clinical use of the nucleus replacement device and also help explain and support the positive clinical results obtained from two European studies and one US pilot study. Clinical Relevance Nucleus replacement devices are rapidly emerging to address specific conditions of degenerative disc disease. Preclinical testing of such devices is paramount in order to potentially ensure successful clinical outcomes post implantation