Are all Cages Created Equal? Analysis of Cervical Cage Malfunctions Using FDA MAUDE Database.

Study Design: Retrospective case series.

Objective: To characterize failure rates of cervical cages based on manufacturer and design characteristics using the nationwide database of reported malfunctions.

Background: The Food and Drug Administration (FDA) aims to ensure the safety and efficacy of cervical interbody implants postimplantation; however, intraoperative malfunctions may be overlooked.

An Analysis of a Decade of Lumbar Interbody Cage Failures in the United States: A MAUDE Database Study.

Study Design: A retrospective case series.

Objective: This study aims to assess the rates of lumbar interbody cage failures based on their material and manufacturer.

Summary Of Background Data: Perioperative lumbar interbody cage malfunctions are underreported events in the spine literature and may result in complications.

Multiexpandable cage for minimally invasive posterior lumbar interbody fusion.

The increasing adoption of minimally invasive techniques for spine surgery in recent years has led to significant advancements in instrumentation for lumbar interbody fusion. Percutaneous pedicle screw fixation is now a mature technology, but the role of expandable cages is still evolving. The capability to deliver a multiexpandable interbody cage with a large footprint through a narrow surgical cannula represents a significant advancement in spinal surgery technology.

Biomechanics of a Posterior Lumbar Motion Stabilizing Device: In Vitro Comparison to Intact and Fused Conditions.

Study Design: Nondestructive flexibility tests were performed in vitro, comparing multiple conditions of fixation in a single group of specimens.

Objective: To compare the biomechanical behavior of the lumbar spine in the intact condition, after implanting a novel motion stabilizer, and after implanting a rigid fixator.

Summary Of Background Data: Two specific scenarios that may benefit from dynamic lumbar stabilization are single-level moderate instability, where the stabilizing tissues are relatively incompetent, and juxta-level to fusion, where the last instrumented level requires intermediate stiffness ("topping off") to prevent transfer of high stresses from the stiffer fusion construct to the intact adjacent levels.

Two-Year Evaluation of the X-STOP Interspinous Spacer in Different Primary Patient Populations With Neurogenic Intermittent Claudication Because of Lumbar Spinal Stenosis.

Study Design: Multicenter, prospective single-arm study in patients diagnosed with neurogenic intermittent claudication because of lumbar spinal stenosis.

Objective: To collect data from 2 different primary patient populations, new participants meeting entry criteria [Continued Access Program (CAP)], or subjects who had been randomly assigned to nonsurgical management in the pivotal Investigational Device Exemption study and failed to respond upon study completion [Crossover Study (COS)].

Summary Of Background Data: The X-STOP interspinous spacer is a minimally invasive treatment option for neurogenic intermittent claudication shown to improve pain, physical functioning, and/or overall quality of life.

Treatment of facet cysts associated with neurogenic intermittent claudication with x-stop.

Background: Facet degeneration often leads to the formation of synovial facet cysts. As facet cysts invade the spinal canal, they become a contributing factor to spinal stenosis. Previous studies have demonstrated successful treatment of neurogenic intermittent claudication (NIC), a major symptom of spinal stenosis, with an interspinous process device.

Scoliosis and interspinous decompression with the X-STOP: prospective minimum 1-year outcomes in lumbar spinal stenosis.

Background Context: The X-STOP interspinous decompression device, as a treatment for neurogenic intermittent claudication (NIC) because of lumbar spinal stenosis (LSS), has been shown to be superior to nonoperative control treatment. Current Food and Drug Administration labeling limits X-STOP use to NIC patients with a maximum of 25° concomitant lumbar scoliosis. This value was arrived at arbitrarily by the device developers and is untested.

A novel technique of intra-spinous process injection of PMMA to augment the strength of an inter-spinous process device such as the X STOP.

Study Design: Biomechanical.

Objective: To determine if cement injection into the spinous process will improve compression strength.

Summary Of Background Data: The X STOP (St.

ProDisc-L total disc replacement: a comparison of 1-level versus 2-level arthroplasty patients with a minimum 2-year follow-up.

Study Design: This is a retrospective analysis of data that was collected prospectively from 2 concurrent FDA IDE lumbar arthroplasty clinical trials performed at a single center.

Objective: To determine if there is a clinical difference between the 1-level ProDisc patients versus the 2-level ProDisc patients at a minimum of 2 years of follow-up.

Summary Of Background Data: Marnay's work with ProDisc I prompted the U.

Measurement of in vivo lumbar intervertebral disc pressure during spinal manipulation: a feasibility study.

This paper presents the first reported measurements of lumbar intervertebral disc pressure in vivo during spinal manipulation. A pressure transducer was inserted into the nucleus pulposus of one normal-appearing lumbar disc in an asymptomatic adult volunteer. Pressures were recorded during several body positions and maneuvers, then during spinal manipulation, and lastly during a repetition of the preintervention body positions.

Quality of life of lumbar stenosis-treated patients in whom the X STOP interspinous device was implanted.

Object: This study was conducted to compare the quality of life (QOL) in patients with neurogenic intermittent claudication (NIC) secondary to lumbar spinal stenosis (LSS). Using the 36-Item Short Form (SF-36) questionnaire, the authors compared the results obtained in patients treated with the X STOP Interspinous Process Decompression (IPD) System with those obtained in patients who underwent nonoperative therapies.

Methods: Patients with LSS were enrolled in a prospective 2-year multicenter study and randomized either to the X STOP or nonoperative group.

Interspinous process decompression with the X-STOP device for lumbar spinal stenosis: a 4-year follow-up study.

X-STOP is the first interspinous process decompression device that was shown to be superior to nonoperative therapy in patients with neurogenic intermittent claudication secondary to spinal stenosis in the multicenter randomized study at 1 and 2 years. We present 4-year follow-up data on the X-STOP patients. Patient records were screened to identify potentially eligible subjects who underwent X-STOP implantation as part of the FDA clinical trial.

A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication: two-year follow-up results.

Study Design: A randomized, controlled, prospective multicenter trial comparing the outcomes of neurogenic intermittent claudication (NIC) patients treated with the interspinous process decompression system (X STOP) with patients treated nonoperatively.

Objective: To determine the safety and efficacy of the X STOP interspinous implant.

Summary Of Background Data: Patients suffering from NIC secondary to lumbar spinal stenosis have been limited to a choice between nonoperative therapies and decompressive surgical procedures, with or without fusion.

The use of an interspinous implant in conjunction with a graded facetectomy procedure.

Study Design: The range of motion (ROM) of lumbar cadaver spines was measured during flexion, extension, axial rotation, and lateral bending following graded facetectomies and implantation of an X STOP interspinous spacer implant.

Objective: The study was performed undertaken to understand better the influence of the interspinous spacer implant on the kinematics of the lumbar spine following graded facetectomies.

Summary Of The Background Data: Lateral lumbar spinal stenosis is often treated with a unilateral or bilateral facetectomy procedure.

Insertion loads of the X STOP interspinous process distraction system designed to treat neurogenic intermittent claudication.

An interspinous process implant has been developed to treat patients suffering from neurogenic intermittent claudication secondary to lumbar spinal stenosis. As most patients who suffer from spinal stenosis are over the age of 50 and may have weaker bones, it is imperative to know how bone mineral density (BMD) correlates with lateral spinous process strength. The study was undertaken to characterize the lateral failure loads of the spinous process, correlate the failure loads to BMD, and compare the failure loads to the loads required to insert an interspinous process implant.

The effects of an interspinous implant on the kinematics of the instrumented and adjacent levels in the lumbar spine.

Study Design: Measurement of the kinematics of the lumbar spine after insertion of an interspinous spacer in vitro.

Objectives: To understand the kinematics of the instrumented and adjacent levels due to the insertion of this interspinous implant.

Summary Of Background Data: An interspinous spacer (X Stop, SFMT, Concord, California) has been developed to treat neurogenic intermittent claudication by placing the stenotic segment in slight flexion and preventing extension.

The effects of an interspinous implant on intervertebral disc pressures.

Study Design: Measurement of intradiscal pressure was performed after placement of an interspinous implant in a cadaver model.

Objective: To understand the likelihood of accelerated adjacent-level disc degeneration as a result of the implant.

Summary Of Background Data: An interspinous implant has been developed to treat lumbar neurogenic claudication secondary to spinal stenosis that places the stenotic segment in slight flexion and prevents extension.

Gadopentetate dimeglumine as an intradiscal contrast agent.

Study Design: Magnetic resonance discography using gadolinium as an intradiscal contrast agent was investigated in a prospective study.

Objective: To evaluate the utility of magnetic resonance discography using gadolinium as an intradiscal contrast agent, as compared with the current standard of computed tomographic discography using intradiscal iodinated contrast agent.

Summary Of Background Data: Magnetic resonance arthrography with gadolinium has been used to evaluate shoulder, elbow, wrist, hip, knee, and other joints.