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

Spinal Stenosis Clinical Trial

— In-Space  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00697827
• Other study ID #: INSP01
• Status: Terminated
• Phase: Phase 3
• First received: June 11, 2008
• Last updated: June 5, 2012
• Start date: June 2008
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: Synthes USA HQ, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis

Intervention

Device:
• Interspinous Spacer device
Device: In-Space
• Interspinous Process Distraction Device
Device: X STOP

Locations

Country	Name	City	State
United States	OrthoCarolina Spine Center	Charlotte	North Carolina
United States	Institute for Low Back and Neck Care	Minneapolis	Minnesota
United States	Neurosurgical Associates at Centennial Medical Center	Nashville	Tennessee
United States	Yale Orthopedics	New Haven	Connecticut
United States	Cornell University Hospital	New York	New York
United States	Neurosurgical Specialists, Inc.	Norfolk	Virginia
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Texas Back Institute	Plano	Texas
United States	The Spine Institute	Santa Monica	California
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Synthes USA HQ, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No