Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical Degenerative Disc Disease
This study is ongoing, but not recruiting participants.
Sponsored by: Medtronic Spine, Biologics & Navigation
Information provided by: Medtronic Spine, Biologics & Navigation
ClinicalTrials.gov Identifier: NCT00667459
  Purpose

The purpose of this clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at a single level from C3-C4 to C6-C7.


Condition Intervention Phase
Cervical Degenerative Disc Disease
Device: PRESTIGE® LP Cervical Disc
Device: ATLANTIS Anterior Cervical Plate
Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Prospective, Multicenter, Controlled Clinical Trial of an Artifical Cervical Disc LP at a Single Level for Symptomatic Cervical Disc Disease

Further study details as provided by Medtronic Spine, Biologics & Navigation:

Primary Outcome Measures:
  • Primary endpoint is overall success,consisting of NDI success,neurological status maintenance/improvement, disc height success, no serious AE classified as implant associated or implant/surgical proc. No second surgery classified as "failure" [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary Outcomes: SF-36 patient survey,neck and arm pain status,patient satisfaction, and patient global perceived effect [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: January 2005
Estimated Study Completion Date: January 2009
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
PRESTIGE® LP Cervical Disc
Device: PRESTIGE® LP Cervical Disc
The PRESTIGE® LP Cervical Disc is inserted into the intervertebral disc space of the cervical spine using the anterior surgical approach.
2
The study uses a group of patients who received a ACDF fusion treatment in a previous IDE trial (G010188)
Device: ATLANTIS Anterior Cervical Plate
Anterior cervical discectomy and fusion with ATLANTIS plate from control group from IDE study G010188.

Detailed Description:

This pivotal clinical trial is being conducted to compare treatment data of the investigational implant device,the PRESTIGE® LP Cervical Disc, with a control patient group receiving a plate. The PRESTIGE® LP Cervical Disc device will be implanted using an anterior surgical approach. Data from control patients receiving anterior cervical discectomy and fusion with an ATLANTIS Anterior Cervical Plate from the initial Artificial Cervical Disc study (IDE # G010188)will be compared as both treatment groups receive single-level surgical treatment from C3-C4 to C6-C7 for symptomatic cervical degenerative disc disease.

  Eligibility

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

Inclusion Criteria:

  • Has cervical degenerative disc disease as defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression that is documented by patient history: a) herniated disc; b) osteophyte formation
  • One level requiring surgical treatment
  • C3-C4 disc to C6-C7 disc level involvement
  • Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or signs of cord compression
  • No previous surgical procedures at the involved level or any planned surgical procedure at the involved or adjacent level.
  • Preop Neck Disability index score ≥ 30
  • Preop Neck Pain score of ≥ 20 based on the Preop Neck & Arm Pain Questionnaire
  • Not pregnant at time of surgery
  • Willing and able to comply with study plan and able to understand and sign patient informed consent

Exclusion Criteria:

  • Any other cervical spinal condition requiring surgical treatment at the involved level
  • Documented or diagnosed cervical instability defined by radiographs showing

    1. Sagittal plane translation > 3.5mm or
    2. Sagittal plane angulation > 20 degrees.
  • More than one cervical level requiring surgery
  • A fused level adjacent to the level to be treated
  • Severe pathology of the facet joint of involved bodies
  • Previous surgery at the involved level
  • Previously diagnosed osteopenia or osteomalacia
  • Any of the following that may be associated with an osteoporosis diagnosis (if "Yes" to any of these, a DEXA Scan will be required to determine eligibility)

    1. Postmenopausal non-Black female over 60 years of age and weighs less than 140 pounds
    2. Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture
    3. Male over the age of 70
    4. Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.

If the level of Bone Mineral Density is a T score of -3.5 or lower or a T score of -2.5 or lower with the vertebral crush fracture, then the patient is excluded.

  • Presence of spinal metastases
  • Overt or active bacterial infection, either local or systemic
  • Severe insulin dependent diabetes
  • Chronic or acute renal failure or history of renal disease
  • Temperature > 101º F oral at surgery
  • Documented allergy to stainless steel, titanium or a titanium alloy
  • Mentally incompetent
  • Is a prisoner
  • Is pregnant
  • Is an alcohol and/or drug abuser
  • Has received drugs which may interfere with bone metabolism within 2 weeks prior to the planned surgery date (steroids, methotrexate), excluding routine preop anti-inflammatories)
  • A history of endocrine or metabolic disorder known to affect osteogenesis
  • A condition that requires postop medications that interfere with the stability of the implant (steroids). This does not include low dose aspirin therapy.
  • Received treatment with an investigational therapy within 28 days prior to surgery or planned for 16 weeks following implantation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667459

Locations
United States, Alabama
Montgomery Neurosurgical
Montgomery, Alabama, United States, 36106
United States, Florida
Orlando Neurosurgery
Winter Park, Florida, United States, 32789
United States, Georgia
The Hughston Clinic, P.C.
Columbus, Georgia, United States, 31908
Atlanta Brain & Spine Care
Atlanta, Georgia, United States, 30309
United States, Illinois
Loyola University Medical Center Neuro
Maywood, Illinois, United States, 60153
United States, Indiana
OrthoIndy
Indianapolis, Indiana, United States, 46260
United States, Iowa
Cedar Neurological Surgeons, PC
Cedar Rapids, Iowa, United States, 52403
United States, Missouri
Springfield Neurological Institute
Springfield, Missouri, United States, 65804
The Orthopaedic Center of St. Louis
Chesterfield, Missouri, United States, 63017
United States, New Hampshire
New Hampshire Neurospine Insititute
Bedford, New Hampshire, United States, 03110
United States, New York
Buffalo Neurosurgery Group
West Seneca, New York, United States, 14224
Beth Israel Medical Center
New York, New York, United States, 10003
United States, Oregon
Oregon Neurosurgery Specialists
Eugene, Oregon, United States, 97401
United States, South Carolina
Charleston Neurosurgical Associates
Charleston, South Carolina, United States, 29414
United States, Tennessee
Neurological Surgeons, P.C.
Nashville, Tennessee, United States, 37203
United States, Texas
Brain and Spine Center of Texas, L.L.P.
Plano, Texas, United States, 75093
United States, Virginia
University of Virginia,Neurosurgery Department
Charlottesville, Virginia, United States, 22908
Virginia Spine Institute
Reston, Virginia, United States, 20190
United States, Washington
Inland Neurosurgery & Spine Associates, P.S.
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Medtronic Spine, Biologics & Navigation
  More Information

Responsible Party: Clinical Affairs, Clinical Affairs, Reimbursement & Health Policy ( Ed Hord/Sr. Manager )
Study ID Numbers: PRESTIGE® LP Protocol, #P03-03
Study First Received: April 24, 2008
Last Updated: April 24, 2008
ClinicalTrials.gov Identifier: NCT00667459  
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Spine, Biologics & Navigation:
Cervical Disc

Study placed in the following topic categories:
Spinal Diseases
Musculoskeletal Diseases
Bone Diseases

ClinicalTrials.gov processed this record on January 16, 2009