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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

In-Space

Group Type EXPERIMENTAL

Interspinous Spacer device

Intervention Type DEVICE

Device: In-Space

2

X STOP

Group Type ACTIVE_COMPARATOR

Interspinous Process Distraction Device

Intervention Type DEVICE

Device: X STOP

Interventions

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Interspinous Spacer device

Device: In-Space

Intervention Type DEVICE

Interspinous Process Distraction Device

Device: X STOP

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ≥ 50 years in age
* Leg/buttock/groin pain, with or without back pain, that can be completely relieved by flexion such as when sitting in a chair.
* Zurich Claudication Questionnaire Score ≥ 2.0,
* Neurogenic intermittent claudication secondary to moderate lumbar spinal stenosis
* Has completed at least 6 months conservative therapy

Exclusion Criteria

* Axial back pain only without leg/buttock/groin pain
* Has had any prior lumbar spine surgery at any level
* Significant scoliosis, defined as Cobb angle \> 10°
* Spondylolisthesis \> Grade 1 or isthmic spondylolisthesis at affected level
* Osteoporosis
* Morbid obesity, defined as BMI \> 40 kg/m2

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No