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

June 5, 2012 updated by: Synthes USA HQ, Inc.

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • The Spine Institute
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale Orthopedics
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Institute for Low Back and Neck Care
    • New York
      • New York, New York, United States, 10021
        • Cornell University Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • OrthoCarolina Spine Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Neurosurgical Associates at Centennial Medical Center
    • Texas
      • Plano, Texas, United States, 75093
        • Texas Back Institute
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Neurosurgical Specialists, Inc.
    • Washington
      • Tacoma, Washington, United States, 98341
        • Madigan Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zurich Claudication Questionnaire(ZCQ)
Time Frame: 24 months
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)
Time Frame: 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synthes USA HQ, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 11, 2008

First Submitted That Met QC Criteria

June 13, 2008

First Posted (Estimate)

June 16, 2008

Study Record Updates

Last Update Posted (Estimate)

June 11, 2012

Last Update Submitted That Met QC Criteria

June 5, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INSP01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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