The study group.

The present invention provides an intervertebral implant for implantation in a treated area of an intervertebral space between vertebral bodies of a spine. The implant includes a spacer portion having an inferior and superior surface, wherein the inferior and superior surfaces each have a contact area capable of engaging with anatomy in the treated area, and the inferior and superior surfaces define a through-hole extending through the spacer body. The present invention further provides screw holes extending from a side portion to the inferior and superior surfaces of the spacer portion and a plate portion rigidly coupled to the spacer portion through a coupling means, wherein the plate portion contains screws holes for receiving screws. A screw back out prevention mechanism adapted on the plate portion and prevents the back out of screws from the screw holes.

Intervertebral fusion implant

An intervertebral spacer implant (80) is provided with a retention mechanism (86) to help alleviate expulsion and movement of the implant when placed in the spine while providing an implant that is easier to insert in the spine. In one embodiment the retention mechanism comprises a keel on at least one of the inferior or superior faces of the spacer implant preferably extending in an anterior-posterior direction. In another embodiment the implant comprises a spacer (84) and a plate (82), the plate comprising a supplemental or alternative retention mechanism. In one embodiment the retention mechanism comprises one or more holes (88) in the anterior end of the plate. In yet another embodiment, the retention mechanism comprises one or more blades that are in a first position when inserted and are preferably rotated to a second position that engages the superior and inferior vertebrae.

Intervertebral implant with fixation geometry

An implant for insertion into a disc space between vertebrae, wherein the implant includes a spacer portion, a plate portion coupled to the spacer portion, two bone fixation elements for engaging the vertebrae and a retention mechanism for preventing the bone fixation elements from postoperatively backing-out of the plate portion The retention mechanism may be in the form of a spring biased snapper element that is biased into communication with the bone fixation elements so that once the bone fixation element advances past the snapper element, the snapper element is biased back to its initial position in which the snapper element interfaces with the bone fixation elements Alternatively, the retention mechanism may be in the form of a propeller rotatable between a first position in which the bone fixation elements are insertable to a second position where the bone fixation elements are prevented from backing-out

Zero-profile interbody spacer and coupled plate assembly

STUDY DESIGN Prospective cohort study comparing evaluations of single-level anterior lumbar interbody fusion (ALIF) versus anteroposterior lumbar fusion (APLF) OBJECTIVE To clinically and radiologically compare the outcome after angle-stable, locked, stand-alone ALIF with that obtained after APLF, in cases with degenerative disc disease (DDD) SUMMARY OF BACKGROUND DATA Fusion rates have been reported to be highest after interbody fusion with transpedicular fixation However, transpedicular fixation is linked to significant damage of the paravertebral muscles, to screw displacement-related neurological and vascular complications, and to an increased rate of adjacent segment degeneration When performed as a stand-alone procedure, the disadvantages of transpedicular fixation can be completely avoided by ALIF METHODS Eighty patients with chronic low-back pain due to a single-level DDD (Modic ≥2) and facet joint arthritis (Fujiwara ≥3) were enrolled in this study Forty patients received an anteroposterior fusion (ALIF with transpedicular fixation: APLF group) and 40 patients (ALIF group) were treated with a stand-alone ALIF using the Synfix-LR device At 7 days, 3, 6, 12, and 24 months, and at a mean follow-up of 41 months, patients were clinically (visual analog scale, Oswestry Low Back Pain Disability Index, satisfaction) and radiologically (x-ray, and at 12 months, thin-slice computed tomography) compared RESULTS Blood loss and duration of surgery were significantly lower in the ALIF group (P<0001) Visual analog scale and Oswestry Low Back Pain Disability Index improved significantly over time (analysis of variance, P<0001) in both groups, but both scores were significantly better in ALIF group (analysis of variance, P<0001) Patients' satisfaction consistently ranked higher in the ALIF group (P=0042 at 12 mo) No significant difference was found in the fusion rate throughout the study CONCLUSIONS Stand-alone ALIF leads to better clinical results than APLF, without differences in fusion rates after 41 months Therefore, when a posterior approach is not needed for decompression or reposition, we suggest performing a stand-alone ALIF in cases with single-level DDD

Stand-alone anterior versus anteroposterior lumbar interbody single-level fusion after a mean follow-up of 41 months.

Segmental instability in degenerative disc disease is often treated with anterior lumbar interbody fusion (ALIF). Current techniques require an additional posterior approach to achieve sufficient stability. The test device is an implant which consists of a PEEK-body and an integrated anterior titanium plate hosting four diverging locking screws. The test device avoids posterior fixation by enhancing stability via the locking screws. The test device was compared to an already established stand alone interbody implant in a human cadaveric three-dimensional stiffness test. In the biomechanical test, the L4/5 motion segment of 16 human cadaveric lumbar spines were isolated and divided into two test groups. Tests were performed in flexion, extension, right and left lateral bending, right and left axial rotation. Each specimen was tested in native state first, then a discectomy was performed and either of the test implants was applied. Finite element analysis (FE) was also performed to investigate load and stress distribution within the implant in several loading conditions. The FE models simulated two load cases. These were flexion and extension with a moment of 5 Nm. The biomechanical testing revealed a greater stiffness in lateral bending for the SynFix-LR™ compared to the established implant. Both implants showed a significantly higher stiffness in all loading directions compared to the native segment. In flexion loading, the PEEK component takes on most of the load, whereas the majority of the extension load is put on the screws and the screw–plate junction. Clinical investigation of the test device seems reasonable based on the good results reported here.

/pdf/biomechanical-comparison-of-two-different-concepts-for-stand-3o6e7w0o52.pdf

Biomechanical comparison of two different concepts for stand alone anterior lumbar interbody fusion.

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Biomechanical comparison of two different concepts for stand alone anterior lumbar interbody fusion.