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Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant

2014-08-27 03:16:20 | BioPortfolio

Summary

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, buttock or groin pain with or without lower back pain when walking a certain distance or reclining. Bending forward or sitting leads to a rapid pain relief. Lumbar spinal stenosis is defined as a reduction of the diameter of the spinal canal. The mechanism leading to stenosis is a remodeling and overgrowth of the spinal canal with osteophyte formation. Any loss of tissue or decrease of the disc height results in a relative laxity of the ligament structures and accelerates the degeneration of the spinal joints. As a therapy option, conservative therapy with oral analgesics and physical therapy is considered. This treatment can be intensified by adding epidural pain treatment. Is the conservative treatment not successful surgical intervention is necessary. In patients over 65 years of age operative decompression of the lumbar spinal stenosis constitutes the most common surgical operation of the spine. A relatively new therapy alternative is the interspinous process decompression (IPD). Studies have shown that the IPDs prevent narrowing of the spinal canal and neural foramens. The study is intended as a randomised, monocentre study to investigate the safety and the benefit of a minimally invasive percutaneous IPD-device in comparison with the best non-surgical operative treatment of lumbar spinal stenosis.

Study Design

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

Conditions

Lumbar Spinal Stenosis

Intervention

Spacer, SSPDA

Location

University Hospital of Cologne
Cologne
Germany
50924

Status

Not yet recruiting

Source

University of Cologne

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:20-0400

Clinical Trials [1412 Associated Clinical Trials listed on BioPortfolio]

Feasibility Study of NL-Prow Interspinous Spacer to Treat Lumbar Spinal Stenosis

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

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PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration

A retrospective study that aims to report Adjacent Segment Degeneration (ASD) incidence and spinopelvic balance in short lumbosacral instrumentation for degenerative lumbar spinal stenosis...

Study of MILD® Devices in Patients With Symptomatic Lumbar Spinal Stenosis

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PubMed Articles [2634 Associated PubMed Articles listed on BioPortfolio]

Diagnosis of Lumbar Spinal Stenosis with Functional Myelography.

 The diagnosis of a lumbar spinal stenosis demands advanced diagnostic radiologic techniques. In recent decades magnetic resonance imaging (MRI) has replaced myelography, now considered an old-fashi...

Tandem Spinal Stenosis: A Systematic Review.

Tandem spinal stenosis refers to spinal canal diameter narrowing in at least 2 distinct regions of the spine, most commonly the lumbar and cervical regions. This entity can be an asymptomatic radiogra...

Fusion or Not for Degenerative Lumbar Spinal Stenosis: A Meta-Analysis and Systematic Review.

Degenerative lumbar spinal stenosis (DLSS) is the main cause for chronic low back pain in the elderly. When refractory to conservative treatment, symptomatic patients commonly undergo surgery. However...

Vertebral Compression Fractures after Lumbar Instrumentation.

Lumbar spinal stenosis (LSS) is primarily found in an older population. This is a similar demographic group that develops both osteoporosis and vertebral compression fractures (VCF). This report revie...

Limaprost or pregabalin: preoperative and postoperative medication for pain due to lumbar spinal stenosis.

We aimed to evaluate the incidence of (and risk factors for) postoperative pregabalin and/or limaprost to treat persistent numbness and/or pain of the lower extremities after lumbar spinal stenosis (L...

Medical and Biotech [MESH] Definitions

Tapping of the subarachnoid space in the lumbar region, usually between the third and fourth lumbar vertebrae.

Narrowing of the spinal canal.

The lumbar and sacral plexuses taken together. The fibers of the lumbosacral plexus originate in the lumbar and upper sacral spinal cord (L1 to S3) and innervate the lower extremities.

A nerve originating in the lumbar spinal cord (usually L2 to L4) and traveling through the lumbar plexus to provide motor innervation to extensors of the thigh and sensory innervation to parts of the thigh, lower leg, and foot, and to the hip and knee joints.

A nerve originating in the lumbar spinal cord (L2 to L4) and traveling through the lumbar plexus to the lower extremity. The obturator nerve provides motor innervation to the adductor muscles of the thigh and cutaneous sensory innervation of the inner thigh.

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