Spinal StenosisNCT00534235

Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis

A study testing Decompression, Posterolateral Fusion and Implantation of Pedicle Screws and Implantation of coflex Interlaminar Technology in people with Spinal Stenosis, run by Paradigm Spine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis Read more about this study

Who is it for?: Any age
Conditions the study is for: Spinal Stenosis
What is being tested?: Decompression, Posterolateral Fusion and Implantation of Pedicle Screws and Implantation of coflex Interlaminar Technology
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 322 participants
Where: No sites listed yet
Study dates: Oct 2012to Dec 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 Any age
No healthy volunteers
Child, Adult, Older adult

About this study

Official title: Post-Approval Study to Investigate The Long Term (5-Year) Survivorship of Coflex Compared to Control Fusion Study Patients

Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis

Read the detailed description

The primary objective of this post-approval study is to examine the long-term survivorship of the coflex®. The coflex® Interlaminar Technology is an interlaminar stabilization device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).

Conditions: Spinal Stenosis
Being tested: Decompression, Posterolateral Fusion and Implantation of Pedicle Screws, Implantation of coflex Interlaminar Technology
Medical subject headings: Spinal Stenosis

What participants receive

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

DecompressionProcedure or surgery
Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain
Posterolateral Fusion and Implantation of Pedicle ScrewsDevice
Implantation of coflex Interlaminar TechnologyDevice

Study groups in NCT00534235
Study group	Role	What they receive
Posterolateral Fusion w/Pedicle Screws	Active comparator	Control: Posterolateral fusion and implantation of pedicle screws after decompression Receives: Procedure: Decompression; Device: Posterolateral Fusion and Implantation of Pedicle Screws
coflex Interlaminar Technolgy	Active comparator	Investigative: Implantation of coflex Interlaminar Technology after decompression Receives: Procedure: Decompression; Device: Implantation of coflex Interlaminar Technology

What is being measured

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

Number of Subjects With Improvement of at Least 15 Points in ODI
The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI) in both treatment groups at 5 years. It will be assessed if the improvement in ODI since the pre surgery status in the coflex™ group is better than the improvement in the control group (scale 0-100 with a higher score representing increased disability).
Measured: 5 years
Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation
Assessment of secondary surgical interventions, i.e., reoperations, revisions, removals, or supplemental fixation associated with either coflex or control group. Refer to FDA guidance for complete definitions (https://www.fda.gov/RegulatoryInformation/Guidances/ucm072263.htm).
Measured: 5 years
Number of Subjects With no Major Device Related Complications
Assessment of major device-related complications at 5 years
Measured: 5 years
Number of Subjects With no Epidural Injection(s)
Assessment of lumbar epidural injections
Measured: 5 years
Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit
No persistent new or increasing sensory or motor deficit
Measured: 5 years
Number of Subjects With no Persistent New or Increasing Sensory Deficit
No persistent new or increasing sensory deficit
Measured: 5 years
Number of Subjects With no Persistent New or Increasing Motor Deficit
No persistent new or increasing motor deficit
Measured: 5 years
Number of Subjects With no Reoperations or Epidural (Up to Day 1825)
No reoperations, revisions, removals or supplemental fixation and no epidural injection at any lumbar level up to and including the Month 60 visit.
Measured: 5 years

Secondary outcomes (21)

Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points
ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.
Measured: 5 years
Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points
ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
Measured: 5 years
Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component
Assessment of the patient's Quality of Life as measured by SF-12. Scores range from 0 to 100, where a zero score indicates the lowest level of health. Success was defined as subjects who maintained or improved from their SF-12 score at baseline.
Measured: 5 years
Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component
Assessment of the patient's Quality of Life as measured by SF-12. Scores range from 0 to 100, where a zero score indicates the lowest level of health. Success was defined as subjects who maintained or improved from their SF-12 score at baseline.
Measured: 5 years
Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm
Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.
Measured: 5 years
Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm
Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.
Measured: 5 years
Mean Oswestry Disability Index (ODI) Score
Assessment of disability from low back pain as measured by ODI (Oswestry Disability Index) mean score in each treatment group at 5 years. On a scale of 0-100, a higher score represents increased disability.
Measured: 5 years
Mean Visual Analog Scale Back Pain Score
Assessment of Back Pain as measured by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.
Measured: 5 years
Mean Visual Analog Scale Leg (Worse) Pain Score
Assessment of Worse Leg Pain by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.
Measured: 5 years
Mean Visual Analog Scale (VAS) Leg (Right) Pain Score
Assessment of Right Leg Pain by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.
Measured: 5 years
Mean Visual Analog Scale (VAS) Leg (Left) Pain Score
Assessment of Left Leg Pain by VAS mean score in both treatment groups at 5 years. On a scale of 0-100mm, a higher score represents worse pain.
Measured: 5 years
Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm
Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.
Measured: 5 years
Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm
Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.
Measured: 5 years
Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score
Assessment of symptom severity by ZCQ mean score in both treatment groups at 5 years. ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.
Measured: 5 years
Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score
Assessment of physical function by ZCQ mean score in both groups at 5 years. ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.
Measured: 5 years
Mean Short Form-12 Physical Component Score
Assessment of the patient's Quality of Life as measured by SF-12 mean score in both treatment groups at 5 years. Scores range from 0 to 100, where a zero score indicates the lowest level of health.
Measured: 5 years
Mean Short Form-12 Mental Component Score
Assessment of the patient's Quality of Life as measured by SF-12 mean score in both treatment groups at 5 years. Scores range from 0 to 100, where a zero score indicates the lowest level of health.
Measured: 5 years
Patient Survey: Satisfaction
Subjects who responded "Very Satisfied" or "Somewhat Satisfied".
Measured: 5 years
Patient Survey: Recommendation of Treatment
Subjects who responded "Definitely Yes" or "Probably Yes"
Measured: 5 years
Pain Management: Class II Narcotics Usage by Device Group
Number of subjects using Class II narcotics
Measured: 5 years
Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group
Number of subjects using NSAIDs/ASA/Acetaminophen
Measured: 5 years

Timeline

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

Oct 2012Dec 2015

First posted24 Sep 2007 (estimated)
Study startOct 2012
Primary completionDec 2015
Study completionDec 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: 322 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00534235
Sponsor's protocol ID: PS-001
Status last verified: Jan 2020
First submitted: 20 Sep 2007
Last updated: 6 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Davis R, Auerbach JD, Bae H, Errico TJ. Can low-grade spondylolisthesis be effectively treated by either coflex interlaminar stabilization or laminectomy and posterior spinal fusion? Two-year clinical and radiographic results from the randomized, prospective, multicenter US investigational device exemption trial: clinical article. J Neurosurg Spine. 2013 Aug;19(2):174-84. doi: 10.3171/2013.4.SPINE12636. Epub 2013 May 31.
PubMed 23725394

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?

Official record

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All Spinal Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Approval Study to Investigate The Long Term (5-Year) Survivorship of Coflex Compared to Control Fusion Study Patients
ClinicalTrials.gov ID: NCT00534235
Acronym / sponsor ID: PS-001
Conditions: Spinal Stenosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 322 participants (actual)
Lead sponsor: Paradigm SpineIndustry (pharma, biotech, devices)
Collaborators: MCRA
Study start: Oct 2012
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 24 Sep 2007 (estimated)
Results: Posted 27 Feb 2019

Clinical summary

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

Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis

Detailed description

Study design

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

Arm	Type	Receives
Posterolateral Fusion w/Pedicle Screws	Active comparator	Procedure: Decompression, Device: Posterolateral Fusion and Implantation of Pedicle ScrewsControl: Posterolateral fusion and implantation of pedicle screws after decompression
coflex Interlaminar Technolgy	Active comparator	Procedure: Decompression, Device: Implantation of coflex Interlaminar TechnologyInvestigative: Implantation of coflex Interlaminar Technology after decompression

Who may qualify

Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

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
DecompressionEither microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain	Procedure or surgery	Posterolateral Fusion w/Pedicle Screws, coflex Interlaminar Technolgy
Posterolateral Fusion and Implantation of Pedicle Screws	Device	Posterolateral Fusion w/Pedicle Screws
Implantation of coflex Interlaminar Technology	Device	coflex Interlaminar Technolgy

Primary outcome

Number of Subjects With Improvement of at Least 15 Points in ODI
Time frame: 5 years
The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI) in both treatment groups at 5 years. It will be assessed if the improvement in ODI since the pre surgery status in the coflex™ group is better than the improvement in the control group (scale 0-100 with a higher score representing increased disability).
Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation
Time frame: 5 years
Assessment of secondary surgical interventions, i.e., reoperations, revisions, removals, or supplemental fixation associated with either coflex or control group. Refer to FDA guidance for complete definitions (https://www.fda.gov/RegulatoryInformation/Guidances/ucm072263.htm).
Number of Subjects With no Major Device Related Complications
Time frame: 5 years
Assessment of major device-related complications at 5 years
Number of Subjects With no Epidural Injection(s)
Time frame: 5 years
Assessment of lumbar epidural injections
Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit
Time frame: 5 years
No persistent new or increasing sensory or motor deficit
Number of Subjects With no Persistent New or Increasing Sensory Deficit
Time frame: 5 years
No persistent new or increasing sensory deficit
Number of Subjects With no Persistent New or Increasing Motor Deficit
Time frame: 5 years
No persistent new or increasing motor deficit
Number of Subjects With no Reoperations or Epidural (Up to Day 1825)
Time frame: 5 years
No reoperations, revisions, removals or supplemental fixation and no epidural injection at any lumbar level up to and including the Month 60 visit.

21 secondary outcomes

Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points
Time frame: 5 years
Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points
Time frame: 5 years
Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component
Time frame: 5 years
Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component
Time frame: 5 years
Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm
Time frame: 5 years
Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm
Time frame: 5 years
Mean Oswestry Disability Index (ODI) Score
Time frame: 5 years
Mean Visual Analog Scale Back Pain Score
Time frame: 5 years
Mean Visual Analog Scale Leg (Worse) Pain Score
Time frame: 5 years
Mean Visual Analog Scale (VAS) Leg (Right) Pain Score
Time frame: 5 years
Mean Visual Analog Scale (VAS) Leg (Left) Pain Score
Time frame: 5 years
Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm
Time frame: 5 years
Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm
Time frame: 5 years
Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score
Time frame: 5 years
Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score
Time frame: 5 years
Mean Short Form-12 Physical Component Score
Time frame: 5 years
Mean Short Form-12 Mental Component Score
Time frame: 5 years
Patient Survey: Satisfaction
Time frame: 5 years
Patient Survey: Recommendation of Treatment
Time frame: 5 years
Pain Management: Class II Narcotics Usage by Device Group
Time frame: 5 years
Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group
Time frame: 5 years

Results and safety

Results posted to the registry on 27 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Posterolateral Fusion w/Pedicle Screws	107	91
Coflex Interlaminar Technolgy	215	192

Primary outcome: Number of Subjects With Improvement of at Least 15 Points in ODI

Time frame: 5 years. Count of participants. Unit: Participants

Measure	Posterolateral Fusion w/Pedicle Screws n = 54	Coflex Interlaminar Technolgy n = 126
Value	41	101

Population analysed: The accounting #s in the Patient Flow include all subjects available for CCS evaluation; therefore, the overall # of participants analyzed for each Outcome Measure will differ from the number provided in the Participant Flow as the number provided for each Outcome Measure is the number of patients who completed or were assessed for that measure.

Primary outcome: Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation

Time frame: 5 years. Count of participants. Unit: Participants

Measure	Posterolateral Fusion w/Pedicle Screws n = 107	Coflex Interlaminar Technolgy n = 215
Value	87	179

Primary outcome: Number of Subjects With no Major Device Related Complications

Time frame: 5 years. Count of participants. Unit: Participants

Measure	Posterolateral Fusion w/Pedicle Screws n = 107	Coflex Interlaminar Technolgy n = 215
Value	100	212

Primary outcome: Number of Subjects With no Epidural Injection(s)

Time frame: 5 years. Count of participants. Unit: Participants

Measure	Posterolateral Fusion w/Pedicle Screws n = 107	Coflex Interlaminar Technolgy n = 215
Value	84	177

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Posterolateral Fusion w/Pedicle Screws	64 of 107 (59.8%)	101 of 107 (94.4%)	0 of 107
Coflex Interlaminar Technolgy	109 of 215 (50.7%)	199 of 215 (92.6%)	0 of 215

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23725394Davis R, Auerbach JD, Bae H, Errico TJ. Can low-grade spondylolisthesis be effectively treated by either coflex interlaminar stabilization or laminectomy and posterior spinal fusion? Two-year clinical and radiographic results from the randomized, prospective, multicenter US investigational device exemption trial: clinical article. J Neurosurg Spine. 2013 Aug;19(2):174-84. doi: 10.3171/2013.4.SPINE12636. Epub 2013 May 31.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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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.

Questions about this trial

What is this clinical trial studying?

A study testing Decompression, Posterolateral Fusion and Implantation of Pedicle Screws and Implantation of coflex Interlaminar Technology in people with Spinal Stenosis, run by Paradigm Spine.

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

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

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 Feb 2019). 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 Subjects With Improvement of at Least 15 Points in ODI (time frame: 5 years). The study lists 8 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 NCT00534235, which also lists 1 linked publication.

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 6 Feb 2020.