Back to resultsStudy Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer
Primary Purpose
Lumbar Spinal Stenosis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FLEXUS(TM) Interspinous Spacer
XSTOP® Interspinous Spacer
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Back pain, Pain, Spinal Diseases, Spinal Stenosis, Lumbar Vertebrae, Spinal Canal
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
Sites / Locations
- Skyridge Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FLEXUS™ Interspinous Spacer
XSTOP® Interspinous Spacer
Arm Description
Outcomes
Primary Outcome Measures
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.
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
Palpable or Visible Contraction
Active Movement, Gravity Eliminated
Active Movement, Against Gravity
Active Movement, Against Some Resistance
Active Movement, Against Full Resistance
Sensory 0 Absent
Impaired
Normal
Reflexes 0 Absent or Trace
Hyper-reflexic
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.
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.
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.
Secondary Outcome Measures
Mean Oswestry Disability Index (ODI) at 24 Months
The Oswestry Disability Index (ODI) questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The subject chooses the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. Scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability.
Mean Visual Analog Scale (VAS) - Back Pain at 24 Months
The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of back pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
Mean Visual Analog Scale (VAS) - Right Leg Pain at 24 Months
The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of right leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
Mean Visual Analog Scale (VAS) - Left Leg Pain at 24 Months
The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of left leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
Change of Quality of Life
Change in mental or physical composite score of the short form SF36
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01156675
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Globus Medical Inc
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
Keywords
Back pain, Pain, Spinal Diseases, Spinal Stenosis, Lumbar Vertebrae, Spinal Canal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
215 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FLEXUS™ Interspinous Spacer
Arm Type
Experimental
Arm Title
XSTOP® Interspinous Spacer
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
FLEXUS(TM) Interspinous Spacer
Intervention Description
Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
Intervention Type
Device
Intervention Name(s)
XSTOP® Interspinous Spacer
Intervention Description
Treatment of lumbar spinal stenosis with the XSTOP® Spacer
Primary Outcome Measure Information:
Title
Number of Participants With Less Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Score
Description
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.
Time Frame
24 months
Title
Number of Participants With a Successful Neurologic Status
Description
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
Palpable or Visible Contraction
Active Movement, Gravity Eliminated
Active Movement, Against Gravity
Active Movement, Against Some Resistance
Active Movement, Against Full Resistance
Sensory 0 Absent
Impaired
Normal
Reflexes 0 Absent or Trace
Hyper-reflexic
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.
Time Frame
24 months
Title
Number of Participants With no Additional Surgery for Lumbar Spinal Stenosis at the Spinal Level That Was Treated
Description
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.
Time Frame
24 months
Title
Number of Participants With an Absence of Implant-related Complications
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Mean Oswestry Disability Index (ODI) at 24 Months
Description
The Oswestry Disability Index (ODI) questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The subject chooses the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. Scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability.
Time Frame
24 months
Title
Mean Visual Analog Scale (VAS) - Back Pain at 24 Months
Description
The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of back pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
Time Frame
24 months
Title
Mean Visual Analog Scale (VAS) - Right Leg Pain at 24 Months
Description
The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of right leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
Time Frame
24 months
Title
Mean Visual Analog Scale (VAS) - Left Leg Pain at 24 Months
Description
The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of left leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
Time Frame
24 months
Title
Change of Quality of Life
Description
Change in mental or physical composite score of the short form SF36
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Skyridge Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
12. IPD Sharing Statement
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Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer
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