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The purpose of this study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device ("X STOP") for the treatment of patients experiencing intermittent neurogenic claudication secondary to moderate degenerative lumbar stenosis at one or two lumbar levels.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Interspinous Spacer device, Interspinous Process Distraction Device
The Spine Institute
Active, not recruiting
Published on BioPortfolio: 2014-07-23T21:22:16-0400
The purpose of the study is to evaluate the clinical safety and feasibility of the NL-Prow™ Interspinous Spacer implant and insertion procedure in the treatment of lumbar spinal stenosis
A retrospective study that aims to report Adjacent Segment Degeneration (ASD) incidence and spinopelvic balance in short lumbosacral instrumentation for degenerative lumbar spinal stenosis...
Neurogenic intermittent claudication is a specific symptom complex occurring in patients with lumbar spinal stenosis. Characteristic of this disease is the occurrence of increasing leg, bu...
The purpose of this study is to compare improvement in low back pain with Wallis (interspinous process implant) to exercise and injections.
The purpose of this biomedical research is to evaluate the feasibility of the treatment with the new spinal distraction device ASTS in patients aged 4 to 10 years with severe early onset s...
Recently, interspinous stabilization with Coflex-F implant has become an alternative to treat lumbar spinal stenosis (LSS). However, little attention focused on modifying the structure of the device t...
Limited data have been published showing whether the second-generation Wallis Interspinous Spacer improves function following lumbar spine decompression or discectomy.
To evaluate the long-term results of using the BacJac interspinous device (Pioneer Surgical Technology Inc.) in a series of patients with degenerative lumbar spine disease.
Degenerative lumbar spinal stenosis is a condition related to aging in which structural changes cause narrowing of the central canal and intervertebral foramen. It is currently the leading cause for s...
Bone lengthening by gradual mechanical distraction. An external fixation device produces the distraction across the bone plate. The technique was originally applied to long bones but in recent years the method has been adapted for use with mandibular implants in maxillofacial surgery.
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.
Device designed to wear externally to support muscular skeletal system in various movements such as RANGE OF MOTIONS; WEIGHT-BEARING; GAIT; and LOCOMOTION.
Removal of a MEDICAL DEVICE from the market due to a problem occurring in the manufacture or distribution of the product.
Spinal Cord Disorders
The spinal cord is a bundle of nerves that runs down the middle of the back which carry signals back and forth between the body and brain. It is protected by vertebrae, which are the bone disks that make up the spine. An accident that damages the verte...