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

This study has been terminated.
(Study terminated due to low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier:
NCT00697827
First received: June 11, 2008
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Spinal Stenosis
Device: Interspinous Spacer device
Device: Interspinous Process Distraction Device
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Randomized Controlled Trial of the In-Space Compared to X STOP® for Treatment of Moderate Degenerative Lumbar Spinal Stenosis

Resource links provided by NLM:


Further study details as provided by Synthes USA HQ, Inc.:

Primary Outcome Measures:
  • Zurich Claudication Questionnaire(ZCQ) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Oswestry Disability Index (ODI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 44
Study Start Date: June 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
In-Space
Device: Interspinous Spacer device
Device: In-Space
Active Comparator: 2
X STOP
Device: Interspinous Process Distraction Device
Device: X STOP

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697827

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

No publications provided

Responsible Party: Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier: NCT00697827     History of Changes
Other Study ID Numbers: INSP01
Study First Received: June 11, 2008
Results First Received: May 3, 2012
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 19, 2014