Lumbar Spinal StenosisNCT01156675

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

A study testing FLEXUS(TM) Interspinous Spacer and XSTOP® Interspinous Spacer in people with Lumbar Spinal Stenosis, run by Globus Medical Inc at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Lumbar Spinal Stenosis
What is being tested?: FLEXUS(TM) Interspinous Spacer and XSTOP® Interspinous Spacer
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 215 participants
Where: 1 siteUnited States
Study dates: Jun 2008to Jul 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Skyridge Medical Center
Denver, Colorado, 80124

Other trials in United States

About this study

Official title: A Prospective Randomized Clinical Investigation of the FLEXUS(TM) Interspinous Spacer: A Pivotal Study

Conditions: Lumbar Spinal Stenosis
Being tested: FLEXUS(TM) Interspinous Spacer, XSTOP® Interspinous Spacer
Keywords: Back pain, Pain, Spinal Diseases, Spinal Stenosis, Lumbar Vertebrae, Spinal Canal
Medical subject headings: Spinal Stenosis, Back Pain, Pain, Spinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FLEXUS(TM) Interspinous SpacerDevice
Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
XSTOP® Interspinous SpacerDevice
Treatment of lumbar spinal stenosis with the XSTOP® Spacer

Study groups in NCT01156675
Study group	Role	What they receive
FLEXUS™ Interspinous Spacer	Experimental	Not described Receives: Device: FLEXUS(TM) Interspinous Spacer
XSTOP® Interspinous Spacer	Active comparator	Not described Receives: Device: XSTOP® Interspinous Spacer

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months

Secondary outcomes (5)

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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
Change of Quality of Life
Change in mental or physical composite score of the short form SF36
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Jul 2015

First posted5 Jul 2010 (estimated)
Study startJun 2008
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 215 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01156675
Sponsor's protocol ID: GPR003
Status last verified: May 2018
First submitted: 1 Jul 2010
Last updated: 1 Jun 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruiting
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All Lumbar Spinal Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Randomized Clinical Investigation of the FLEXUS(TM) Interspinous Spacer: A Pivotal Study
ClinicalTrials.gov ID: NCT01156675
Acronym / sponsor ID: GPR003
Conditions: Lumbar Spinal Stenosis
Keywords: Back pain, Pain, Spinal Diseases, Spinal Stenosis, Lumbar Vertebrae, Spinal Canal
Study type: Interventional
Recruitment status: Terminated
Enrolment: 215 participants (actual)
Lead sponsor: Globus Medical IncIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 5 Jul 2010 (estimated)
Results: Posted 27 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
FLEXUS™ Interspinous Spacer	Experimental	Device: FLEXUS(TM) Interspinous Spacer
XSTOP® Interspinous Spacer	Active comparator	Device: XSTOP® Interspinous Spacer

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FLEXUS(TM) Interspinous SpacerTreatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer	Device	FLEXUS™ Interspinous Spacer
XSTOP® Interspinous SpacerTreatment of lumbar spinal stenosis with the XSTOP® Spacer	Device	XSTOP® Interspinous Spacer

Primary outcome

Number of Participants With Less Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Score
Time frame: 24 months
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
Time frame: 24 months
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.
Number of Participants With no Additional Surgery for Lumbar Spinal Stenosis at the Spinal Level That Was Treated
Time frame: 24 months
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
Time frame: 24 months
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.

5 secondary outcomes

Mean Oswestry Disability Index (ODI) at 24 Months
Time frame: 24 months
Mean Visual Analog Scale (VAS) - Back Pain at 24 Months
Time frame: 24 months
Mean Visual Analog Scale (VAS) - Right Leg Pain at 24 Months
Time frame: 24 months
Mean Visual Analog Scale (VAS) - Left Leg Pain at 24 Months
Time frame: 24 months
Change of Quality of Life
Time frame: 24 months

Results and safety

Results posted to the registry on 27 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FLEXUS™ Interspinous Spacer	107	73
X-STOP® Interspinous Spacer	106	81
No Treatment	2	0

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

Time frame: 24 months. Count of participants. Unit: Participants

Measure	FLEXUS™ Interspinous Spacer n = 74	X-STOP® Interspinous Spacer n = 80	No Treatment n = 0
Value	42	50	0

Population analysed: The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module. The discrepancy in the numbers is due to an additional subject having ZCQ data at 24 months in the FLEXUS arm and one less subject with ZCQ data at 24 months in the X-STOP group. No data was collected for the "No Treatment" arm.

Primary outcome: Number of Participants With a Successful Neurologic Status

Time frame: 24 months. Count of participants. Unit: Participants

Measure	FLEXUS™ Interspinous Spacer n = 71	X-STOP® Interspinous Spacer n = 80	No Treatment n = 0
Value	60	69	0

Population analysed: The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to two less subjects having neurologic status data at 24 months in the FLEXUS arm and one less subject with neurologic status data at 24 months in the X-STOP arm. No data was collected for the "No Treatment" arm.

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

Time frame: 24 months. Count of participants. Unit: Participants

Measure	FLEXUS™ Interspinous Spacer n = 107	X-STOP® Interspinous Spacer n = 106	No Treatment n = 0
Value	90	99	0

Population analysed: The Overall Number of Participants Analyzed in the FLEXUS arm and X-STOP arm is the number of subjects who started the Study in the respective arm. No data was collected for the "No Treatment" arm.

Primary outcome: Number of Participants With an Absence of Implant-related Complications

Time frame: 24 months. Count of participants. Unit: Participants

Measure	FLEXUS™ Interspinous Spacer n = 107	X-STOP® Interspinous Spacer n = 106	No Treatment n = 0
Value	84	97	0

Population analysed: The Overall Number of Participants Analyzed in the FLEXUS arm and X-STOP arm is the number of subjects who started the Study in the respective arms. No data was collected for the "No Treatment" arm.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FLEXUS™ Interspinous Spacer	41 of 107 (38.3%)	77 of 107 (72%)	5 of 107
X-STOP® Interspinous Spacer	28 of 106 (26.4%)	72 of 106 (67.9%)	3 of 106
No Treatment	0 of 2 (0%)	2 of 2 (100%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lumbar Spinal Stenosis

Recruiting
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RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FLEXUS(TM) Interspinous Spacer and XSTOP® Interspinous Spacer in people with Lumbar Spinal Stenosis, run by Globus Medical Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Less Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Score (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01156675.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.