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

Study Overview
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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.

Official Title
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A Multi-Center Randomized Controlled Trial of the In-Space Compared to X STOP® for Treatment of Moderate Degenerative Lumbar Spinal Stenosis

Conditions
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Spinal Stenosis

Intervention / Treatment
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* Device: Interspinous Spacer device
* Device: Interspinous Process Distraction Device


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>In-Space | Device: Interspinous Spacer device<br>* Device: In-Space<br>|
| Active Comparator: 2<br>X STOP | Device: Interspinous Process Distraction Device<br>* Device: X STOP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zurich Claudication Questionnaire(ZCQ) | The questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction. The scale relates to symptoms over the past month. The result is expressed as a percentage of the maximum possible score. The score increases with worsening disability. An individual patient treatment will be considered a success if they meet at least two of three components defined as an improvement of ≥ 0.5 as compared to preoperative score for the symptom severity and physical function and an of < 2.5 points for patient satisfaction at 24 months. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) | The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. There are 10 questions. The questions are designed in a way to show how the back or leg pain is affecting the patient's ability to manage in everyday life. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. For this study,any improvement at 24 months compared to pre-operative baseline was determined as a success. | 24 months |