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

Globus Medical

Status

Terminated

Conditions

Lumbar Spinal Stenosis

Treatments

Device: FLEXUS(TM) Interspinous Spacer

Device: XSTOP® Interspinous Spacer

Study type

Interventional

Funder types

Industry

Identifiers

NCT01156675

GPR003

Details and patient eligibility

About

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.

Enrollment

215 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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