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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Globus Medical Inc

ClinicalTrials.gov Identifier:

NCT01156675

First received: July 1, 2010

Last updated: March 15, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	July 1, 2010
Last Updated Date	March 15, 2013
Start Date ^ICMJE	June 2008
Estimated Primary Completion Date	December 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 2, 2010)	Improvement in pain/disability using the Zurich Claudication Questionnaire (ZCQ) score at 24 months compared with the score at baseline [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01156675 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 2, 2010)	Disability score using the Oswestry Disability Index (ODI) score at 24 months compared with the score at baseline [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ] Pain scores for back and leg pain using the Visual Analog Scale (VAS) scores at 24 months compared with the scores at baseline [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ] Quality of life assessments using the SF-36 questionnaire at baseline and 24 months [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ] Radiographic assessments using x-rays taken at baseline and 24 months [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer
Official Title ^ICMJE	A Prospective Randomized Clinical Investigation of the FLEXUS(TM) Interspinous Spacer: A Pivotal Study
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Lumbar Spinal Stenosis
Intervention ^ICMJE	Device: FLEXUS(TM) Interspinous Spacer Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer Device: XSTOP® Interspinous Spacer Treatment of lumbar spinal stenosis with the XSTOP® Spacer
Study Arm (s)	Experimental: FLEXUS™ Interspinous Spacer Intervention: Device: FLEXUS(TM) Interspinous Spacer Active Comparator: XSTOP® Interspinous Spacer Intervention: Device: XSTOP® Interspinous Spacer
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	500
Estimated Completion Date	December 2017
Estimated Primary Completion Date	December 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01156675
Other Study ID Numbers ^ICMJE	GPR003
Has Data Monitoring Committee	Not Provided
Responsible Party	Globus Medical Inc
Study Sponsor ^ICMJE	Globus Medical Inc
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Globus Medical Inc
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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