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A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis

2014-07-23 21:22:16 | BioPortfolio

Summary

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Spinal Stenosis

Intervention

Interspinous Spacer device, Interspinous Process Distraction Device

Location

The Spine Institute
Santa Monica
California
United States
90404

Status

Active, not recruiting

Source

Synthes Spine

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:22:16-0400

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Medical and Biotech [MESH] Definitions

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.

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