INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial (ACDF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT00485173
First received: June 8, 2007
Last updated: February 14, 2013
Last verified: December 2012
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of the investigational implant (INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate) as a method of facilitating spinal fusion at a single level from C3-C7 in patients with symptomatic cervical degenerative disc disease.


Condition Intervention
Degenerative Disc Disease
Device: INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pivotal Clinical Investigation of INFUSE® Bone Graft With a PEEK Interbody Spacer and an Anterior Cervical Plate in Patients With Cervical Degenerative Disc Disease at a Single Level.

Resource links provided by NLM:


Further study details as provided by Medtronic Spinal and Biologics:

Primary Outcome Measures:
  • Rate of Overall Success [ Time Frame: 24 months post-operation ] [ Designated as safety issue: Yes ]

    Rate of overall success is reported as the percentage of participants who met all of the following criteria:

    1. fusion at the treated level;
    2. pain/disability (Neck Disability Index) success;
    3. neurological status success;
    4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated;"
    5. no additional surgical procedure classified as a "failure."


Secondary Outcome Measures:
  • Success Rate of Fusion [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]

    Success Rate of Fusion is reported as percent of participants who met the following fusion criteria:

    1. Evidence of bridging bone. This is based on the evidence of a continuous bony connection from the superior vertebral body to the inferior vertebral body in at least one of the following areas: lateral, anterior, posterior and/or through the PEEK spacer.
    2. No evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface.
    3. No evidence of motion as defined by ≤ 4º of angular motion (based on flexion-extension lateral plain radiographs).

  • Success Rate of Neck Disability Index [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
    Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.

  • Success Rate of Neurological Status [ Time Frame: 24 months post-operation ] [ Designated as safety issue: Yes ]
    Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.

  • Neck Pain Success Rate [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
    Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score > 0.

  • Arm Pain Success Rate [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
    Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score > 0.

  • Success Rate of SF-36 PCS [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
    Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rate of SF-36 PCS was defined as: Post Score - Pre Score >= 0.

  • Success Rate of SF-36 MCS [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
    Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 MCS were defined as: Post Score - Pre Score >= 0.

  • Operative Time [ Time Frame: Time of operation, approximately 1.5 hrs. ] [ Designated as safety issue: No ]
    Operative time was recorded from skin incision to wound closure.

  • Blood Loss [ Time Frame: During the time of operation, approximately 1.5 hours. ] [ Designated as safety issue: No ]
  • Hospital Stay [ Time Frame: During the time of hospital stay, average of 1 day. ] [ Designated as safety issue: No ]
  • Number of Patients Who Had Secondary Surgeries at the Index Level [ Time Frame: 24 months post-operation ] [ Designated as safety issue: Yes ]
    Secondary surgical procedures at the index level included revisions, removal, supplemental fixation and reoperations.


Other Outcome Measures:
  • Neck Disability Index Score [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
    The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).

  • Neck Pain Score [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
    Numerical rating scales are used to evaluate neck pain intensity and frequency. Patients rate their neck pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, patients record their neck pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total neck pain score is the sum of pain intensity and frequency scores.

  • Arm Pain Score [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
    Numerical rating scales are used to evaluate arm pain intensity and frequency. Patients rate their arm pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, patients record their arm pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total arm pain score will be the sum of pain intensity and frequency scores.

  • General Health Status -- SF-36 PCS [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
    The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.

  • General Health Status -- SF-36 MCS [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
    The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS is between 0 and 100, with higher scores denoting better quality of life.

  • Ossification in the Region of Target Level [ Time Frame: 24 months post-operation ] [ Designated as safety issue: No ]
    Ossification in the region of target level is reported as the percentage of the patients who had ossification in the region of the target level. The region of target level included the index level, the superior and inferior adjacent disc spaces, and the superior and inferior adjacent vertebral bodies.


Enrollment: 224
Study Start Date: June 2007
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INFUSE® Bone Graft
In this arm, patients will receive implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Device: INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate
All patients enrolled in this study will receive the investigational device.
Other Name: ACDF, Anterior Cervical Plate

Detailed Description:

This pivotal clinical trial is being conducted to evaluate the safety and effectiveness of INFUSE® Bone Graft with the PEEK Interbody Spacer and Anterior Cervical Plate in patients with symptomatic cervical degenerative disc disease (DDD). The implant under investigation in this clinical trial is INFUSE® Bone Graft, the PEEK Interbody Spacer, and Anterior Cervical Plate. The device will be implanted using an anterior surgical approach. Safety and effectiveness data for patients in this study will be compared to that of historical controls. Historical control data will be taken from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • INCLUSION:

    1. Single-level cervical degenerative disc disease (from C3-C7) requiring surgical treatment and involving intractable radiculopathy and/or myelopathy.
    2. Herniated disc and/or osteophyte formation at the level to be treated that is producing symptomatic nerve root and/or spinal cord compression.
    3. Unresponsive to non-operative treatment for six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management.
    4. At least 18 years of age and skeletally mature at the time of surgery.
    5. A preoperative Neck Disability Index (NDI) score ≥30.
    6. A preoperative neck pain score (pain intensity + pain frequency) ≥8 (out of 20) based on the preoperative Neck and Arm Pain Questionnaire.
    7. If a female of childbearing potential, patient is not pregnant or nursing and agrees not to become pregnant for one year following surgery.
    8. Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

Exclusion Criteria:

  • EXCLUSION:

    1. A cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved level.
    2. Documented or diagnosed cervical instability at the target level, defined by dynamic (flexion/extension) radiographs.
    3. Previous surgical intervention at the involved level.
    4. Any subsequent planned/staged surgical procedure at the involved or adjacent level(s).
    5. Fused level adjacent to the level to be treated.
    6. Severe pathology of the facet joints of the involved vertebral bodies.
    7. Has osteoporosis, osteopenia, or osteomalacia as determined by DEXA scan.
    8. Presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
    9. Overt or active bacterial infection, either local or systemic.
    10. Insulin dependent diabetes.
    11. Chronic or acute renal failure or prior history of renal disease.
    12. Documented allergy or intolerance to stainless steel, titanium, titanium alloy, polyetheretherketone (PEEK), or tantalum.
    13. Is mentally incompetent. (if questionable, obtain psychiatric consult.)
    14. Is a prisoner.
    15. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
    16. On oral or injectable steroids for 6 weeks or more at the time of enrollment.
    17. A history of autoimmune disease.
    18. History of exposure to injectable collagen or silicone implants.
    19. History of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
    20. Received any previous exposure to any/all BMPs either human or animal extraction.
    21. History of allergy to bovine products.
    22. History of any allergy resulting in anaphylaxis.
    23. History of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta).
    24. Condition that requires postoperative medications that interfere with the stability of the implant, such as steroids.
    25. Received treatment with an investigational therapy (drug, device, or biologic) within 28 days prior to implantation surgery or such treatment is planned during the 24-month period following the study surgery.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485173

Locations
United States, California
S & B Surgery Center
Beverly Hills, California, United States, 90210
Orange County Neurological Association
Laguna Hills, California, United States, 92653
United States, Florida
Crane Creek Medical Ctr. The Back Center /Osler Medical
Melbourne, Florida, United States, 32901
United States, Georgia
The Hughston Clinic, P.C.
Columbus, Georgia, United States, 31908
United States, Kansas
University of Kansas Medcal Center
Kansas City, Kansas, United States, 66160
United States, Louisiana
Spine Institute
Shreveport, Louisiana, United States, 71103
United States, Missouri
Springfield Neurological Institute
Springfield, Missouri, United States, 65804
United States, New York
Buffalo Neurosurgery Group
West Seneca, New York, United States, 14224
United States, Ohio
University of Cincinnati Dept of Neurosurgery
Cincinnati, Ohio, United States, 45219
TriState Orthopedic Treatment Center
Norwood, Ohio, United States, 45212
United States, Pennsylvania
The Washington Hospital
Washington, Pennsylvania, United States, 15301
United States, Tennessee
Center for Sports Medcine & Orthopedics
Chattanooga, Tennessee, United States, 37404
Semmes Murphey Neurologic & Spine Institute
Memphis, Tennessee, United States, 38120
United States, Texas
Central Texas Spine
Austin, Texas, United States, 78731
Brain and Spine Center of Texas, L.L.P.
Plano, Texas, United States, 75093
United States, Washington
Inland Neurosurgery & Spine Associates, P.S.
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Medtronic Spinal and Biologics
  More Information

No publications provided

Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT00485173     History of Changes
Other Study ID Numbers: INFUSE® Bone Graft PEEK ACDF
Study First Received: June 8, 2007
Results First Received: December 14, 2012
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disk Degeneration
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 24, 2014