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

Phase 3

Terminated

• Conditions: Spinal Stenosis
• Interventions: Device: Interspinous Process Distraction Device; Device: Interspinous Spacer device

• Registration Number: NCT00697827
• Lead Sponsor: Synthes USA HQ, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-13
• Study First Posted: 2008-06-16
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2012-05-03
• Results First Submitted QC: 2012-05-03
• Status Verified: 2012-06
• Results First Posted: 2012-06-05
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Interspinous Process Distraction Device	X STOP
1	Interspinous Spacer device	In-Space

Primary Outcome Measures

Name	Time	Method
Zurich Claudication Questionnaire(ZCQ)	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.

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	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.

Trial Locations

Locations (10)

Yale Orthopedics; 🇺🇸 New Haven, Connecticut, United States

Cornell University Hospital; 🇺🇸 New York, New York, United States

Neurosurgical Specialists, Inc.; 🇺🇸 Norfolk, Virginia, United States

Madigan Army Medical Center; 🇺🇸 Tacoma, Washington, United States

Neurosurgical Associates at Centennial Medical Center; 🇺🇸 Nashville, Tennessee, United States

The Spine Institute; 🇺🇸 Santa Monica, California, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Institute for Low Back and Neck Care; 🇺🇸 Minneapolis, Minnesota, United States

OrthoCarolina Spine Center; 🇺🇸 Charlotte, North Carolina, United States

Texas Back Institute; 🇺🇸 Plano, Texas, United States