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

Stopped early · Phase 3

Conditions studied: Spinal Stenosis

In brief

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.

Key facts

Study ID

NCT00697827

Run by

Synthes USA HQ, Inc.

People needed

44

Starts

2008-06-01

Expected to finish

2011-06-01

Last updated by the study team

2012-06-11

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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