Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer

NCT ID: NCT01156675

Last Updated: 2018-06-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2015-07-31

Brief Summary

The purpose of this investigation is to evaluate the safety and effectiveness of the FLEXUS™ Interspinous Spacer as compared to the XSTOP® Spacer for the treatment of patients who are suffering from lumbar spinal stenosis at one or two contiguous levels.

Conditions

Lumbar Spinal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FLEXUS™ Interspinous Spacer

Group Type: EXPERIMENTAL

FLEXUS(TM) Interspinous Spacer

Intervention Type: DEVICE

Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer

XSTOP® Interspinous Spacer

Group Type: ACTIVE_COMPARATOR

XSTOP® Interspinous Spacer

Intervention Type: DEVICE

Treatment of lumbar spinal stenosis with the XSTOP® Spacer

Interventions

FLEXUS(TM) Interspinous Spacer

Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer

Intervention Type: DEVICE

XSTOP® Interspinous Spacer

Treatment of lumbar spinal stenosis with the XSTOP® Spacer

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Lumbar spinal stenosis as defined by leg, buttock or groin pain, with or without back pain, that relieves during flexion, with radiographic confirmation of spinal stenosis by CT or MRI scans at one or two contiguous levels between L1 and S1. If back pain is also present, it must be partially relieved during flexion
• Narrowing of the spinal canal, nerve root canal or intervertebral foramen at one or two levels
• Able to sit for 50 minutes without pain
• Able to walk 50 feet or more
• Age 50 years or over
• Has completed at least 6 months of conservative treatment
• Has a Zurich Claudication Questionnaire (ZCQ) score of ≥ 1.5 for Physical Function (PF) and ≥ 1.5 for Symptom Severity (SS)
• Other as specified in the approved protocol

Exclusion Criteria

• Cannot sit for 50 minutes without pain
• Cannot walk for more than 50 feet
• Unremitting pain in any spinal position
• Axial back pain only without leg, buttock, or groin pain
• Fixed motor deficit
• Cauda equine syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retension or incontinence) dysfunction
• Severe symptomatic lumbar spinal stenosis at more than two levels
• Significant instability of the lumbar spine
• Has had any surgery of the lumbar spine
• Morbid obesity defined as a body mass index >40 or a weight more than 100 lbs over ideal body weight
• Active systemic disease such as AIDS, HIV, Hepatitis, etc.
• Active systemic or local infection
• Angina, active rheumatoid arthritis, advanced diabetes or any other systemic disease that would affect the subject's welfare or outcome of the study
• Osteoporosis, defined as DEXA bone density measured T-score < -2.5
• Spinal metastasis to the vertebrae
• Known allergy to device materials titanium, tantalum, or polyetheretherketone (PEEK) polymer
• Other as specified in approved protocol

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Globus Medical Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Skyridge Medical Center

Denver, Colorado, United States

Countries

United States

Other Identifiers

GPR003

Identifier Type: -

Identifier Source: org_study_id