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Degenerative Disc DiseaseACDFNCT00485173

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

A study testing INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate in people with Degenerative Disc Disease, run by Medtronic Spinal and Biologics at 16 sites in United States.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Degenerative Disc Disease
What is being tested?
INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
16 sitesUnited States
Study dates
Jun 2007to Jun 2012
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • A cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved level.
  • Documented or diagnosed cervical instability at the target level, defined by dynamic (flexion/extension) radiographs.
  • Previous surgical intervention at the involved level.
  • Any subsequent planned/staged surgical procedure at the involved or adjacent level(s).
  • Fused level adjacent to the level to be treated.
  • Severe pathology of the facet joints of the involved vertebral bodies.
Show all 25Show fewer
  • Has osteoporosis, osteopenia, or osteomalacia as determined by DEXA scan.
  • Presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
  • Overt or active bacterial infection, either local or systemic.
  • Insulin dependent diabetes.
  • Chronic or acute renal failure or prior history of renal disease.
  • Documented allergy or intolerance to stainless steel, titanium, titanium alloy, polyetheretherketone (PEEK), or tantalum.
  • Is mentally incompetent. (if questionable, obtain psychiatric consult.)
  • Is a prisoner.
  • Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
  • On oral or injectable steroids for 6 weeks or more at the time of enrollment.
  • A history of autoimmune disease.
  • History of exposure to injectable collagen or silicone implants.
  • History of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
  • Received any previous exposure to any/all BMPs either human or animal extraction.
  • History of allergy to bovine products.
  • History of any allergy resulting in anaphylaxis.
  • History of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta).
  • Condition that requires postoperative medications that interfere with the stability of the implant, such as steroids.
  • 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Central Texas Spine

    Austin, Texas, 78731

  • S & B Surgery Center

    Beverly Hills, California, 90210

  • Center for Sports Medcine & Orthopedics

    Chattanooga, Tennessee, 37404

  • University of Cincinnati Dept of Neurosurgery

    Cincinnati, Ohio, 45219

  • The Hughston Clinic, P.C.

    Columbus, Georgia, 31908

  • University of Kansas Medcal Center

    Kansas City, Kansas, 66160

  • Orange County Neurological Association

    Laguna Hills, California, 92653

  • Crane Creek Medical Ctr. The Back Center /Osler Medical

    Melbourne, Florida, 32901

  • Semmes Murphey Neurologic & Spine Institute

    Memphis, Tennessee, 38120

  • TriState Orthopedic Treatment Center

    Norwood, Ohio, 45212

  • Brain and Spine Center of Texas, L.L.P.

    Plano, Texas, 75093

  • Spine Institute

    Shreveport, Louisiana, 71103

  • Inland Neurosurgery & Spine Associates, P.S.

    Spokane, Washington, 99204

  • Springfield Neurological Institute

    Springfield, Missouri, 65804

  • The Washington Hospital

    Washington, Pennsylvania, 15301

  • Buffalo Neurosurgery Group

    West Seneca, New York, 14224

Other trials in United States

About this study

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.

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.

Read the 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).

Being tested
INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate
Medical subject headings
Intervertebral Disc Degeneration

What participants receive

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

  • INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical PlateDevice

    Also called ACDF, Anterior Cervical Plate

    All patients enrolled in this study will receive the investigational device.

Study groups in NCT00485173
Study groupRoleWhat they receive
INFUSE® Bone GraftExperimentalIn this arm, patients will receive implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Receives: Device: INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate

What is being measured

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

  1. Rate of Overall Success

    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."

    Measured: 24 months post-operation

Secondary outcomes (11)

  1. Success Rate of Fusion

    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).

    Measured: 24 months post-operation

  2. Success Rate of Neck Disability Index

    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.

    Measured: 24 months post-operation

  3. Success Rate of Neurological Status

    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.

    Measured: 24 months post-operation

  4. Neck Pain Success Rate

    Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score > 0.

    Measured: 24 months post-operation

  5. Arm Pain Success Rate

    Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score > 0.

    Measured: 24 months post-operation

  6. Success Rate of SF-36 PCS

    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.

    Measured: 24 months post-operation

  7. Success Rate of SF-36 MCS

    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.

    Measured: 24 months post-operation

  8. Operative Time

    Operative time was recorded from skin incision to wound closure.

    Measured: Time of operation, approximately 1.5 hrs.

  9. Blood Loss

    Measured: During the time of operation, approximately 1.5 hours.

  10. Hospital Stay

    Measured: During the time of hospital stay, average of 1 day.

  11. Number of Patients Who Had Secondary Surgeries at the Index Level

    Secondary surgical procedures at the index level included revisions, removal, supplemental fixation and reoperations.

    Measured: 24 months post-operation

Timeline

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

  1. First posted12 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionDec 2011
  4. Study completionJun 2012

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00485173
Sponsor's protocol ID
INFUSE® Bone Graft PEEK ACDF
Acronym
ACDF
Status last verified
Dec 2012
First submitted
8 Jun 2007
Last updated
19 Mar 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate in people with Degenerative Disc Disease, run by Medtronic Spinal and Biologics at 16 sites 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 25 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: finished, as of the sponsor's last update on 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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 19 Mar 2013). 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?

Rate of Overall Success (time frame: 24 months post-operation). 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 NCT00485173.

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 19 Mar 2013.

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