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

NCT01156675 | Terminated Results

• 1 other identifier: GPR003
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

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

Keywords

Back pain; Pain; Spinal Diseases; Spinal Stenosis; Lumbar Vertebrae; Spinal Canal

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Less Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Score

  Change in the Zurich Claudication Questionnaire (ZCQ) score at 24 months compared with the score at baseline as follows: * Change of \>0.5 points in Physical Function on a scale of 1-4 points (lower values are considered a better outcome) * Change of \>0.5 points in Symptom Severity on a scale of 1-5 points (lower values are considered a better outcome) * Satisfaction of \<2.5 points on a scale of 1-4 points (lower values are considered a better outcome) The Zurich Claudication Questionnaire is a three part form that quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment.

  24 months

• Number of Participants With a Successful Neurologic Status

  Neurological status is based on four types of measurement parameters: motor, sensory, reflexes, and special assessments. Each parameter will be coded as follows: Motor 0 Total Paralysis 1. Palpable or Visible Contraction 2. Active Movement, Gravity Eliminated 3. Active Movement, Against Gravity 4. Active Movement, Against Some Resistance 5. Active Movement, Against Full Resistance Sensory 0 Absent 1. Impaired 2. Normal Reflexes 0 Absent or Trace 1. Hyper-reflexic 2. Normal or hypo-reflexic Straight Leg Raise 0 0°-70° (abnormal) 1 \>70°-90° (normal) If all evaluations for the parameter are determined to be normal, then the parameter is given a normal status. If any evaluations for the parameter are abnormal, then the parameter is given an abnormal status. The overall neurological status will be considered a success if and only if all the four parameters are stable or improved.

  24 months

• Number of Participants With no Additional Surgery for Lumbar Spinal Stenosis at the Spinal Level That Was Treated

  Measures the number of participants who did not have another surgery for treatment of lumbar spinal stenosis at the same spinal level that was originally treated. Data, including adverse events, were monitored, evaluated and assessed for evidence of additional surgical treatment at the spinal level that was originally treated.

  24 months

• Number of Participants With an Absence of Implant-related Complications

  Absence of implant-related complications, including device dislodgement, defined as: * Failure of implant material (e.g. fracture); * Implant migration outside of the interspinous space (posteriorly beyond the posterior margin of the spinous processes, anteriorly within the spinal canal, or laterally more than half of the implant width); or * Other complications that can be specifically associated with the implanted device.

  24 months

Secondary Outcomes (5)

• Mean Oswestry Disability Index (ODI) at 24 Months

  24 months

• Mean Visual Analog Scale (VAS) - Back Pain at 24 Months

  24 months

• Mean Visual Analog Scale (VAS) - Right Leg Pain at 24 Months

  24 months

• Mean Visual Analog Scale (VAS) - Left Leg Pain at 24 Months

  24 months

• Change of Quality of Life

  24 months

Study Arms (2)

FLEXUS™ Interspinous Spacer

EXPERIMENTAL

Device: FLEXUS(TM) Interspinous Spacer

XSTOP® Interspinous Spacer

ACTIVE COMPARATOR

Device: XSTOP® Interspinous Spacer

Interventions

FLEXUS(TM) Interspinous Spacer DEVICE

Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer

FLEXUS™ Interspinous Spacer

XSTOP® Interspinous Spacer DEVICE

Treatment of lumbar spinal stenosis with the XSTOP® Spacer

XSTOP® Interspinous Spacer

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Globus Medical Inc: lead

Study Sites (1)

Skyridge Medical Center

Denver, Colorado, 80124, United States

Location

MeSH Terms

Conditions

Spinal Stenosis; Back Pain; Pain; Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director, Clinical Affairs
• Organization: Globus Medical

jmyer@globusmedical.com

610-930-1800

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 5, 2010
• Study Start: June 1, 2008
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 1, 2018
• Results First Posted: April 27, 2018

Record last verified: 2018-05

Locations

US (1)