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 device's compressive, shear properties, and fatigue testing to determine the device's 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.

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 nucleus pulposus 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.

Atlantoaxial fusion using anterior transarticular screw fixation of C1-C2: technical innovation and biomechanical study.

This study is an attempt to describe a new technique for anterior transarticular screw fixation of the atlantoaxial joints, and to compare the stability of this construct to posterior transarticular screw fixation with and without laminar cerclage wiring. Nine human cadaveric specimens were included in this study. The C1-C2 motion segment was instrumented using either anterior transarticular screws (group 1), posterior transarticular screws alone (group 2), or posterior screws with interlaminar cerclage wires (group 3). Using an unconstrained mechanical testing machine, the specimens were tested in rotation, lateral bending, and flexion-extension using nondestructive loads of +/-2 N m. The specimens were also tested in translation using nondestructive loads of +/-100 N. All values for the three groups with regards to anterior-posterior displacement, rotation, and lateral bending were similar as determined using a Kruskal-Wallis rank sum test with a significance level of p<0.05. The only significant difference was registered in flexion-extension where the cerclage wire added some strength to the construct. Anterior transarticular screw fixation of the atlantoaxial spine has several advantages over posterior fixation techniques, and is as stable as posterior transarticular fixation in all clinically significant planes of motion. The addition of posterior interlaminar cerclage wiring further improves resistance to flexion-extension forces. Anterior transarticular screw fixation of the atlantoaxial joint is a useful technique for achieving C1-C2 stabilization.