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Fenestrated Screw Study (FNS)

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ClinicalTrials.gov Identifier: NCT03797144
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

Brief Summary:
The primary objective of this post-market study is to demonstrate that Oswestry disability index (ODI) score improved significantly at 12 months post-operatively as compared to baseline for each indication (degenerative spinal disease and deformity) in subjects with compromised bone quality, who will receive a surgical procedure requiring posterior stabilization and/or immobilization of one or more spinal segments using CD HORIZON® Fenestrated Screw Spinal System with Fenestrated Screw Cement.

Condition or disease Intervention/treatment Phase
Degenerative Spinal Disease Deformity of Spine Device: CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Evaluation of the CD HORIZON® Fenestrated Screw Spinal System With Fenestrated Screw Cement When Used in the Treatment of Spinal Conditions in Subjects With Compromised Bone Quality
Actual Study Start Date : April 18, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fenestrated Screw System Device: CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement
The CD HORIZON® Legacy™ and Solera™ Fenestrated Screw Spinal System consists of a variety of cannulated screws with a series of fenestrations to allow polymethylmethacrylate (PMMA) bone cement (Fenestrated Screw Cement) to be injected into the treated site. The Fenestrated Screw Cement is used to augment screw fixation in subjects with compromised bone quality.




Primary Outcome Measures :
  1. Change in ODI (Oswestry Disability Index) at 12 months compared to baseline [ Time Frame: Baseline to 12 months ]

    Disability associated with thoracic/lumbar spine conditions will be assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders.

    ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100.



Secondary Outcome Measures :
  1. Change in ODI from Baseline at 3 and 24 month visit from baseline [ Time Frame: Baseline, 3, 24 months ]

    Disability associated with thoracic/lumbar spine conditions will be assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. [23]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders.

    ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100.


  2. Change in VAS (Visual Analogue Scale) back and leg pain score at 3, 12, and 24 month from baseline [ Time Frame: Baseline, 3, 12, 24 ]
    Levels of back pain and leg pain will be measured using the Visual Analogue Scales (VAS). Subjects will be asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.

  3. Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3, 12, and 24 month from baseline [ Time Frame: Baseline, 3, 12, 24 month ]
    The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire will be used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS will also be utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).

  4. Rate of neurological success at 12-month visit [ Time Frame: Baseline to 12 months ]

    Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales will be used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (positive = patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, normal = no pain experienced).

    Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve).


  5. Rate of intraoperative cement extravasation/leakage. [ Time Frame: Baseline to 24 months ]
    The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.

  6. Device and/or procedure related to adverse events through 24 months. [ Time Frame: Baseline to 24 months ]
    Device and/or procedure related adverse events will be collected through 24 months follow-up.

  7. Rate of secondary spinal surgeries at index and/or adjacent level(s), resulting from an AE up to 24 months after surgery [ Time Frame: Baseline to 24 months ]
    When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of insufficient outcomes of the initial surgery.

  8. Radiographic confirmation of stabilization of the pedicle screw instrumentation at 12-month visit. [ Time Frame: Baseline to 12 months ]

    The surgeon or hospital radiologist will review radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months. The following will be considered as signs of instrumentation instability:

    • Screw pullout
    • Screw loosening
    • Screw toggle

  9. Radiographic fusion at 12-month visit for those subjects where fusion was intended [ Time Frame: Baseline to 12 months ]

    The surgeon or hospital radiologist will determine fusion status for those subjects where fusion is intended. The fusion assessment for each subject will be collected at 12 months, preferably by collecting a CT-scan, alternatively fusion may also be collected through X-rays.

    Fusion status will be classified as the following: No fusion success, Fusion success, and Unable to determine. The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should be recorded as "No fusion success".

    For multi-level subjects, fusion success will be assessed for each level and overall fusion status will be defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level is considered unable to determine.


  10. For Deformity subjects only: Change in coronal and sagittal spinopelvic parameters from baseline at the 12-month visit. [ Time Frame: Baseline to 12 months ]

    Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery. Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters will be assessed in the deformity patients on standing, frontal and sagittal full spine X-ray:

    • Coronal alignment - Distance between C7 plumb line and the central sacral vertical line, and Coronal curve type
    • Sagittal alignment - Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). Global parameter: Sagittal vertical axis (SVA)
    • Sagittal spinopelvic parameters: Pelvic Incidence (PI): Pelvic Tilt (PT) and Sacral Slope (SS)



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A subject must meet the following inclusion criteria to participate in this trial:

  1. One or more of the following diagnostic indications:

    • Degenerative Spinal Disease (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis)
    • Deformity (e.g. degenerative deformity)
  2. Degenerative Spinal Disease patients only: Patient has been unresponsive to non-operative treatment for at least three months or has progressive symptoms or signs of nerve root/spinal cord compression while undergoing continued non-operative management.
  3. Compromised bone quality defined as a hip DXA scan T-score less than or equal to -1.0 or spine quantitative CT (qCT) actual volumetric bone mineral density threshold of ≤ 120 mg/cm3.
  4. Requires a procedure with an instrumented, posterior thoracic and/or lumbar spinal stabilization and/or immobilization.
  5. Is scheduled to receive a construct using CD Horizon® Spinal System components with at least one Fenestrated Screw cemented with Fenestrated Screw Cement.
  6. At least 22 years old or greater at the time of informed consent.
  7. Is able to understand and willing to sign the Patient Informed Consent Form.
  8. Is willing and able to undergo the study procedure and perform the follow up visits.

Exclusion Criteria:

  • A subject will be excluded from participating in this trial for any of the following reasons:

    1. Has undergone stabilization and/or fusion procedure at the index or adjacent levels.
    2. Will undergo vertebroplasty or kyphoplasty procedure during surgery.
    3. Has been diagnosed with cauda equina syndrome.
    4. Has been previously diagnosed with clinically significant peripheral neuropathy.
    5. Has any degree of permanent neurologic deficit due to the presenting spinal disease (e.g. drop foot or gait deficit).
    6. Has obesity defined by BMI greater than or equal to 35kg/m2.
    7. Has documented allergy to the materials that will be used in the surgical or any imaging procedure (e.g. titanium alloys, cobalt-chromium-molybdenum alloys and PMMA Fenestrated Screw Cement, contrast medium)
    8. Has overt or active bacterial infection, local or systemic, and/or potential for bacteremia.
    9. Has a non-correctable spontaneous or therapeutic coagulation disorder or history of coagulation disorder associated with bleeding.
    10. Has evolutive cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) nonreactive to medical treatment.
    11. Has any disease (e.g., neuromuscular disease, etc.) that would preclude the potential benefit and/or accurate clinical evaluation of the safety of the spinal implant surgery.
    12. Is pregnant or planning to become pregnant during the study duration.
    13. Is illiterate or considered vulnerable as per the Investigator's assessment (e.g., participants incapable of judgment, or participants under tutelage).
    14. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results*.

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): NCT03797144


Contacts
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Contact: Ellen Konings +31 43 3566 585 ellen.konings@medtronic.com

Locations
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Finland
Tyks Surgical Hospital Recruiting
Turku, Finland, 20700
Principal Investigator: Juho Rantakokko         
Italy
IRCCS Istituto Clinico Humanitas di Milano Not yet recruiting
Rozzano, Italy, 20086
Principal Investigator: Maurizio Fornari         
Sponsors and Collaborators
Medtronic Spinal and Biologics

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Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT03797144     History of Changes
Other Study ID Numbers: MDT17040SD1703
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Spinal Diseases
Bone Diseases
Musculoskeletal Diseases