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Trial record 3 of 9 for:    coflex

Post-Approval 'Real Conditions of Use' Study (PAS003)

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ClinicalTrials.gov Identifier: NCT02555280
Recruitment Status : Recruiting
First Posted : September 21, 2015
Last Update Posted : May 21, 2021
Sponsor:
Collaborator:
MCRA, LLC
Information provided by (Responsible Party):
Surgalign Spine Technologies

Brief Summary:
A 2 and 5 year comparative evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the coflex® Interlaminar Technology for FDA Real Conditions of Use Study.

Condition or disease Intervention/treatment Phase
Spinal Stenosis Lumbar Device: coflex® Interlaminar Technology Procedure: Decompression Not Applicable

Detailed Description:
A prospective, multi center, concurrently enrolled, propensity score controlled through Month 60. The purpose is to evaluate coflex device performance in a "real conditions of use" study.Subjects will be evaluated pre-operatively, at the time of surgery, 3- month, 12- month and annually thereafter at 24-, 36-, 48-, 60-months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 406 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 2 and 5 Year Comparative Evaluation of Clinical Outcomes in the Treatment of Degenerative Spinal Stenosis With Concomitant Low Back Pain by Decompression With and Without Additional Stabilization Using the Coflex®
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : November 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Experimental: The coflex® Interlaminar Technology
The coflex device was designed to address the clinical needs of spinal stenosis patients by providing stabilization of the affected level without fusion. The coflex is an interspinous process functional dynamic implant designed to impart a stabilizing effect at the treated level(s). The coflex device was approved by FDA in 2012.
Device: coflex® Interlaminar Technology
Decompression plus coflex® Interlaminar Technology
Other Name: coflex

Active Comparator: Decompression
Lumbar decompression back surgery is when a small portion of the bone over the nerve root and/or disc material from under the nerve root is removed to give the nerve root more space and provide a better healing environment.
Procedure: Decompression
Decompression alone




Primary Outcome Measures :
  1. To evaluate 5-year clinical status of patients implanted with the coflex® device in conjunction with surgical decompression relative to decompression alone. [ Time Frame: 60 Months ]
    This objective will be accomplished by a Baysesian test of superiority using Month 60 composite clinical success and has three parts: 1) At least a 15 point improvement relative to pretreatment baselin in the Oswestry Disability Index (ODI, range 0-100) 2) No reoperations, revisions, removals, or supplemental fixation at the index level(s); and 3) No ≥2 injections or series of injections for any lumbar level**, or nerve block procedures performed to treat spinal stenosis at any lumbar level(s) or a single injection within 12 months of the 5 year endpoint.

  2. To compare clinical status of patients implanted with the coflex® device in conjunction with surgical decompression relative to surgical decompression alone [ Time Frame: 24 Months ]

    The objective will be achieved by conducting a Bayesian test and Month 24 CSS will require:

    • No "Treatment Failure" on or before the exact 2-year anniversary of the index surgery. Treatment Failure will include:

      1. Surgical intervention at the index level
      2. No lumbar epidural steroid injection including nerve root blocks and facet blocks at any lumbar level
    • At least a 15 point improvement relative to pretreatment baseline in the Oswestry Disability Index (ODI, range 0-100).
    • No major device-related adverse event defined as an event simultaneously both 'Serious' and 'Definitely' on or before the exact surgical two-year anniversary or exact five-year anniversary. In the decompression alone group, since there is no device, this endpoint will be identified as any serious AE that is classified as definitely related to surgery as determined by the independent Clinical Events Committee (CEC).

  3. If non-inferiority is shown at two-years, to evaluate evidence supporting superiority at two-years in terms of Month 24 CCS using the same informative prior distribution for the coflex group. [ Time Frame: 24 Months ]
    • No "Treatment Failure" on or before the exact 2-year anniversary of the index surgery. Treatment Failure will include:

      1. Surgical intervention at the index level
      2. No lumbar epidural steroid injection including nerve root blocks and facet blocks at any lumbar level
    • At least a 15 point improvement relative to pretreatment baseline in the Oswestry Disability Index (ODI, range 0-100).
    • No major device-related adverse event defined as an event simultaneously both 'Serious' and 'Definitely' on or before the exact surgical two-year anniversary or exact five-year anniversary. In the decompression alone group, since there is no device, this endpoint will be identified as any serious AE that is classified as definitely related to surgery as determined by the independent Clinical Events Committee (CEC).

  4. To evaluate coflex® device performance in a 'real conditions of use' study and to confirm that coflex® device performance is not clinically inferior in the PAS population compared to the pivotal IDE trial population. [ Time Frame: 24 Months ]
    The same Month 24 CCS endpoint used in the IDE trial will be used in these analyses to facilitate this comparison. The definition required no Treatment Failure, and ODI improvement greater than or equal to 15, as well as no new or worsening, persistent neurological deficit; and no major device-related adverse event defined as severe and definitely-related.


Secondary Outcome Measures :
  1. Change in ODI (Oswestry Disability Index) compared to baseline at 24 and 60 months. [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    The Oswestry Low Back Pain Disability Index (ODI) will be used to assess the impairment on patients' life by low back pain. Range is from 0100. For this study, subjects must achieve at least a 15 point improvement.

  2. Change in Visual Analog Scale (VAS) for low back pain after 24 and 60 months compared to baseline. [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    Low back pain as measured by VAS on the scale from 0 (no pain) to 100 (worst imaginable pain). For this study, subjects must achieve at least a 20 point improvement.

  3. Change in Visual Analog Scale (VAS) for leg pain after 24 and 60 months compared to baseline. [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    Leg pain as measured by VAS on the scale from 0 (no pain) to 100 (worst imaginable pain). For this study, subjects must achieve at least a 20 point improvement.

  4. Change in Visual Analog Scale (VAS) for worst leg pain after 24 and 60 months compared to baseline. [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    Worst leg pain as measured by VAS on the scale from 0 (no pain) to 100 (worst imaginable pain). For this study, subjects must achieve at least a 20 point improvement.

  5. Change in Zurich Claudication Questionnaire (ZCQ) after 24 and 60 months compared to baseline. [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    Overall Success (improvement in 2 of 3 components) and Component Success (improvement in symptom severity ≥0.5, physical function ≥0.5, and satisfaction ≤2.5)

  6. Maintenance or improvement in EQ-5D-3L Health Questionnaire compared to baseline. [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    The EQ-5D is a standardized instrument used as a measure of health outcomes. It contains questions in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and provides a simple descriptive profile and single index for health status preference. In addition, there is a Visual Analog Scale (VAS). The VAS is the participant's rating of their health on a scale of 0 "worst imaginable health state" to 100 "best imaginable health state".

  7. Change from baseline to Month 24 and 60 in maximum walking time from Walking Treadmill Test (WDT) [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    Improvement in Walking Time(minutes;seconds)

  8. Change from baseline to Month 24 and 60 in time to symptoms from Walking Treadmill Test (WDT) [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    Improvement in Symptoms (Pain, Weakness, Fatigue, Other) - Recorded as Yes or No

  9. Neurological Changes/Muscle Strength -assessment of maintenance of improvement after surgery throughout study duration [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    No new or worsening, persistent neurological deficit based on investigators grading of muscle strength (listed for nerve roots from L1-S1; Score 0-5).

  10. Neurological Changes/Sensory Deficit-assessment of maintenance of improvement after surgery throughout study duration [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    No new or worsening, persistent neurological deficit based on investigators grading of sensory deficits (listed for nerve roots from L1-S1; scoring: absent, impaired, normal)

  11. Neurological Changes/Reflexes-assessment of maintenance of improvement after surgery throughout study duration [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    No new or worsening, persistent neurological deficit based on investigators grading of reflexes (listed for Knee Jerk and Ankle Jerk; Score from 0 to 4)

  12. Neurological Changes/Straight Leg Raise-assessment of maintenance of improvement after surgery throughout study duration [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    No new or worsening, persistent neurological deficit based on investigators assessment of Straight Leg Raise (listed for Straight Leg Raise and Reverse Leg Raise; scoring positive or negative).

  13. Radiographic - Device Mobility [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    Device mobility will be classified as less than 5mm or greater than or equal to 5mm lift-off of the device from the inferior spinous process (coflex group only)

  14. Radiographic - Device Migration / Expulsion [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    Device migration / expulsion will be noted if movement is greater than or equal to 5mm (coflex group only)

  15. Radiographic - Spinous Process Fracture [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    Spinous process fractures will be classified as absent or present. If present, fracture location, displacement (displaced or non-displaced), and healing (Grade 0-5) will be recorded.

  16. Radiographic - Foraminal Height [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    Change in foraminal height will be measured in mm

  17. Radiographic - Adjacent Level Disease [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    Adjacent level disease will be assessed using the Kellgren-Lawrence Scale (Grade 0-4)

  18. Radiographic - Other complications [ Time Frame: Baseline, 3, 12, 24, 36, 48, 60 Months ]
    Any other expected or unexpected complications will be assessed

  19. Modified CCS [ Time Frame: 24 Month ]
    CCS will be modified to include no use of a narcotic (opioids or opiates).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Radiographic confirmation of at least moderate lumbar stenosis, which narrows the central spinal canal at one or two contiguous levels from L1-L5 that require surgical decompression. Moderate stenosis is defined as > 25% reduction of the antero-posterior dimension compared to the next adjacent normal level, with nerve root crowding compared to the normal level, as determined by the investigator on computerized tomography (CT) Scan or MRI. The patient may have, but is not required to have for inclusion in the study:

    1. Facet hypertrophy and subarticular recess stenosis at the affected level(s);
    2. Foraminal stenosis at the affected level(s);
    3. Up to stable Grade I degenerative spondylolisthesis (Meyerding classification) or equivalent retrolisthesis as determined by flexion/extension X ray:

    (i) For single level disease, there may be up to a stable Grade I spondylolisthesis or equivalent retrolisthesis at the affected level as determined on flexion/extension files by the investigator.

    (ii) For two level disease, there may be up to a stable Grade I spondylolisthesis or equivalent retrolisthesis at ONLY ONE of the two contiguous affected levels as determined on flexion/extension films by the investigator. Patients with up to stable Grade I spondylolisthesis at two contiguous levels are excluded, but patients with up to Grade I stable spondylolisthesis at the adjacent level may be included.

    (d) Mild lumbar scoliosis (Cobb angle up to 25º)

  2. Radiographic confirmation of no angular or translatory instability of the spine at index or adjacent levels (instability as defined by White & Panjabi: Sagittal plane translation >4.5mm or 15% or sagittal plane rotation >15° at L1-L2, L2-L3, and L3-L4; >20° at L4-L5 based on standing flexion/extension X-rays)
  3. Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale.
  4. Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair.
  5. Patient has undergone at least one lumbar injection (as defined in Section 5.1.3.) at any prior time point, AND at least 6 months of prior conservative care without adequate and sustained symptom relief.
  6. Skeletally mature
  7. Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%).
  8. Appropriate candidate for treatment using posterior surgical approach.
  9. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
  10. Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

  1. More than two contiguous vertebral levels requiring surgical decompression.
  2. Prior surgical procedure that resulted in translatory instability of the lumbar spine [as defined by White & Panjabi (see 3.4.1 Inclusion Criteria, Item #2)].
  3. More than one surgical procedure at any combination of lumbar levels.
  4. Prior fusion, implantation of a total disc replacement, complete laminectomy, or implantation of an interspinous process device at index level.
  5. Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture).
  6. Severe facet hypertrophy that requires extensive bone removal which would cause instability.
  7. Isthmic spondylolisthesis or spondylolysis (pars fracture).
  8. Degenerative lumbar scoliosis (Cobb angle of greater than 25°).
  9. Disc herniation at any lumbar level requiring surgical intervention.
  10. Osteopenia: A screening questionnaire for osteopenia, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA (dual-energy x-ray absorptiometry) bone mineral density measurement. If DEXA is required*, exclusion will be defined as a DEXA bone density measured T score of ≤ -1.0 (The World Health Organization definition of osteopenia).
  11. Back or leg pain of unknown etiology.
  12. Axial back pain only, with no leg, buttock, or groin pain.
  13. Morbid obesity defined as a body mass index > 40.
  14. Pregnant or interested in becoming pregnant in the next three years.
  15. Known allergy to titanium, titanium alloys, or MR (magnetic resonance) contrast agents.
  16. Active or chronic infection - systemic or local.
  17. Chronically taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids), not including a medrol dose pack.
  18. History of significant peripheral neuropathy.
  19. Significant peripheral vascular disease (e.g., with diminished dorsalis pedis or posterior tibial pulses).
  20. Unremitting back pain in any position.
  21. Uncontrolled diabetes.
  22. Known history of Paget's disease, osteomalacia, or any other metabolic bone disease (excluding osteopenia, which is addressed above).
  23. Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.
  24. Fixed and complete motor, sensory, or reflex deficit.
  25. Rheumatoid arthritis or other autoimmune diseases.
  26. Known or documented history of communicable disease, including AIDS, HIV, active Hepatitis
  27. Active malignancy: a patient with a history of any invasive malignancy (except nonmelanoma skin cancer), unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least five years. Patients with a primary bony tumor are excluded as well.
  28. Prisoner or ward of the state.
  29. Subject has a history of substance abuse (e.g., recreational drugs, narcotics, or alcohol).
  30. Subject is currently involved in a study of another investigational product for similar purpose.
  31. Currently seeking or receiving workman's compensation.
  32. In active spinal litigation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555280


Contacts
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Contact: Michelle Foley 202-552-5846 mfoley-adams@mcra.com
Contact: Abigail Allen 202-552-5800 aallen@mcra.com

Locations
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United States, Colorado
20_Spine Colorado, PC Recruiting
Durango, Colorado, United States, 81301
Contact: Juliana Hill    970-375-3696    jhill@spinecolorado.com   
Principal Investigator: Douglas Orndorff, MD         
United States, Florida
Tallahassee Neurological Clinic Not yet recruiting
Tallahassee, Florida, United States, 32308
Contact: Lutheria Hollis    850-201-2350    lhollis@tnc-neuro.com   
Principal Investigator: Albert Lee, MD         
United States, Illinois
01L_Northshore University Health System Active, not recruiting
Evanston, Illinois, United States, 60201
United States, Indiana
24_Unity Surgical Center, LLC Recruiting
Lafayette, Indiana, United States, 47905
Contact: Hayley Wolfe    765-426-1391    HWolfe@UnityHC.com   
Principal Investigator: John Gorup, MD         
25_Orthopedic Specialist of Northwest Indiana Recruiting
Munster, Indiana, United States, 46321
Contact: Mike Kryzskowski, PA    219-924-3300 ext 125    mkrzyskowski@osni.org   
Principal Investigator: Nitin Khanna, MD         
United States, Louisiana
01_Spine Institute of Louisiana Recruiting
Shreveport, Louisiana, United States, 71101
Contact: Marcus Stone, PhD    318-629-5585    MStone@louisianaspine.org   
Contact: Melanie Rosier    318-629-6335    MRosier@louisianaspine.org   
Principal Investigator: Pierce Nunley, MD         
Sub-Investigator: David Cavanaugh, MD         
Sub-Investigator: Andrew Utter, MD         
Sub-Investigator: Eubulus Kerr, MD         
United States, New Jersey
26_St. Joseph's University Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Stuart Changoor    908-329-5673    stuartchangoor@gmail.com   
Principal Investigator: Michael Faloon, MD         
United States, New York
23_University Orthopaedic Associates at Great Neck Recruiting
Great Neck, New York, United States, 11021
Contact: Peter Olivares    516-305-3219    polivares@northwell.edu   
Principal Investigator: Rohit Verma, MD         
United States, Pennsylvania
03L_Thomas Jefferson University Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
22_Austin Brain & Spine Recruiting
Austin, Texas, United States, 78746
Contact: Kelly Van Schouwen    512-751-7747    kelly@researchtex.com   
Principal Investigator: Daniel Peterson, MD         
Sponsors and Collaborators
Surgalign Spine Technologies
MCRA, LLC
Investigators
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Study Director: Fran Magee Paradigm Spine
  Study Documents (Full-Text)

Documents provided by Surgalign Spine Technologies:
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Responsible Party: Surgalign Spine Technologies
ClinicalTrials.gov Identifier: NCT02555280    
Other Study ID Numbers: PS3/P110008
First Posted: September 21, 2015    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Surgalign Spine Technologies:
moderate lumbar stenosis
neurogenic claudication
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases