Clinical trial NCT01156675: Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer
Official title: A Prospective Randomized Clinical Investigation of the FLEXUS(TM) Interspinous Spacer: A Pivotal Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Keywords: Back pain
Pain
Spinal Diseases
Spinal Stenosis
Lumbar Vertebrae
Spinal Canal
Lead sponsor: Globus Medical Inc
Sponsor class: INDUSTRY
First posted: 2010-07-05
Enrollment: 215
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Less Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Score
timeFrame: 24 months
measure: Number of Participants With a Successful Neurologic Status
timeFrame: 24 months
measure: Number of Participants With no Additional Surgery for Lumbar Spinal Stenosis at the Spinal Level That Was Treated
timeFrame: 24 months
measure: Number of Participants With an Absence of Implant-related Complications
timeFrame: 24 months
Secondary outcomes:
measure: Mean Oswestry Disability Index (ODI) at 24 Months
timeFrame: 24 months
measure: Mean Visual Analog Scale (VAS) - Back Pain at 24 Months
timeFrame: 24 months
measure: Mean Visual Analog Scale (VAS) - Right Leg Pain at 24 Months
timeFrame: 24 months
measure: Mean Visual Analog Scale (VAS) - Left Leg Pain at 24 Months
timeFrame: 24 months
measure: Change of Quality of Life
timeFrame: 24 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Skyridge Medical Center
state: Colorado
Study officials:
References: