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

Phase 3TerminatedNCT00697827

Synthes USA HQ, Inc.44 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Stenosis

Interventions

Interspinous Spacer deviceDEVICE

Device: In-Space

Interspinous Process Distraction DeviceDEVICE

Device: X STOP

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (10)

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

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Secondary Outcomes

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.

Time frame: 24 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.