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

DePuy Synthes

Status and phase: Terminated; Phase 3

Conditions: Spinal Stenosis

Treatments: Device: Interspinous Process Distraction Device; Device: Interspinous Spacer device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00697827

INSP01

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

1

Experimental group

Description:

In-Space

Treatment:

Device: Interspinous Spacer device

2

Active Comparator group

Description:

X STOP

Treatment:

Device: Interspinous Process Distraction Device