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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
  Purpose

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.


Condition Intervention Phase
Lumbar Spinal Stenosis
 Device: FLEXUS(TM) Interspinous Spacer
Device: XSTOP® Interspinous Spacer
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Clinical Investigation of the FLEXUS(TM) Interspinous Spacer: A Pivotal Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Globus Medical Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: June 2008
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FLEXUS™ Interspinous Spacer Device: FLEXUS(TM) Interspinous Spacer
Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
Active Comparator: XSTOP® Interspinous Spacer Device: XSTOP® Interspinous Spacer
Treatment of lumbar spinal stenosis with the XSTOP® Spacer

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156675

Locations
United States, Colorado
Skyridge Medical Center
Denver, Colorado, United States, 80124
Sponsors and Collaborators
Globus Medical Inc
  More Information

No publications provided

Responsible Party: Globus Medical Inc
ClinicalTrials.gov Identifier: NCT01156675     History of Changes
Other Study ID Numbers: GPR003
Study First Received: July 1, 2010
Last Updated: March 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Globus Medical Inc:
Back pain
Pain
Spinal Diseases
 Spinal Stenosis
Lumbar Vertebrae
Spinal Canal

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on June 18, 2013