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PRESTIGE® Cervical Disc Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00642876
Recruitment Status : Completed
First Posted : March 25, 2008
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this clinical investigation is to evaluate the safety and effectiveness of the ACD in the single level surgical treatment of patients with symptomatic cervical degenerative disc disease. The primary follow-up information obtained from this clinical investigation are used to support a PMA application for the ACD.

Condition or disease Intervention/treatment
Degenerative Cervical Disc Disease Device: Allograft Fusion and ATLANTIS™ Cervical Plate System Device: PRESTIGE® Cervical Disc

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 541 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of the PRESTIGE® Cervical Disc Device at a Single Level for Symptomatic Cervical Disc Disease
Study Start Date : October 2002
Primary Completion Date : July 2006
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Control
The Control cohort are patients that receive the fusion treatment.
Device: Allograft Fusion and ATLANTIS™ Cervical Plate System
The patients that received the control treatment underwent a single level anterior cervical fusion procedure involving allograft bone and the ATLANTIS™ Cervical Plate System.
Other Name: ATLANTIS™
Experimental: Investigational
The Investigational cohort are the study patients that received the PRESTIGE® Cervical Disc.
Device: PRESTIGE® Cervical Disc
The PRESTIGE® Cervical Disc is a stainless steel device that was inserted into the intervertebral disc space. The device is composed of two metal plates that interface via a ball and socket mechanism permitting segmental spinal motion.
Other Name: PRESTIGE®


Outcome Measures

Primary Outcome Measures :
  1. The primary endpoint is overall success, which consists of NDI score, neuro status success, with/without FSU disc ht success, no serious AE classified as "implant/surgical procedure associated", and no secondary surgical procedure classified as failure [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. The secondary outcomes are radiographic success, medical outcomes SF-36 patient survey (MCS & PCS) success, neck pain status, arm pain status, patient satisfaction, patient global perceived effect, gait assessment, foraminal compression test [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

All patients participating in this study must meet all of the following inclusion criteria:

  1. Cervical degenerative disc disease defined as:

    intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by patient history (e.g., neck and/or arm pain], functional deficit, and/or neurological deficit, and radiographic studies (e.g., CT, MRI, x-rays, etc).

    1. herniated disc;
    2. osteophyte formation;
  2. One cervical level requiring surgical treatment;
  3. C3-C4 disc to C6-C7 disc level of involvement;
  4. Unresponsive to non-operative treatment for approximately 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;
  5. No previous surgical intervention at the involved level or any subsequent, planned/staged surgical procedure at the involved or adjacent level(s);
  6. Is at least 18 years of age, inclusive, at the time of surgery;
  7. Preoperative Neck Disability Index score > or = 30;
  8. Has a preoperative neck pain score of > 20 based on the Preoperative Neck and Arm Pain Questionnaire.
  9. If of child-bearing potential, patient is not pregnant at the time of surgery;
  10. Is willing to comply with the study plan and sign the Patient Informed Consent Form.

Exclusion Criteria:

A patient meeting any of the following criteria is to be excluded from the study:

  1. Has a cervical spinal condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level;
  2. Documented or diagnosed cervical instability defined by dynamic (flexion/extension) radiographs showing:

    1. Sagittal plane translation > 3.5 mm or;
    2. Sagittal plane angulation > 20.
  3. More than one cervical level requiring surgical treatment;
  4. Has a fused level adjacent to the level to be treated;
  5. Has severe pathology of the facet joints of the involved vertebral bodies;
  6. Previous surgical intervention at the involved level;
  7. Has been previously diagnosed with osteopenia or osteomalacia;
  8. Has any of the following that may be associated with a diagnosis of osteoporosis (if Yes to any of the below risk factors, 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 BMD is a T score of -3.5 or a T score of -2.5 with vertebral crush fracture, then the patient is excluded from the study.

  9. Has presence of spinal metastases;
  10. Has overt or active bacterial infection, either local or systemic;
  11. Has severe insulin dependent diabetes;
  12. Has chronic or acute renal failure or prior history of renal disease;
  13. Has fever (temperature > 101 F oral) at the time of surgery;
  14. Has a documented allergy or intolerance to stainless steel, titanium, or a titanium alloy;
  15. Is mentally incompetent. (If questionable, obtain psychiatric consult);
  16. Is a prisoner;
  17. Is pregnant;
  18. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse;
  19. Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs;
  20. Has a history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta);
  21. Has a condition that requires postoperative medications that interfere with the stability of the implant or fusion, such as steroids. (This does not include low dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs);
  22. Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the16 weeks following Artificial Cervical Disc implantation.
Contacts and Locations

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): NCT00642876


  Show 31 Study Locations
Sponsors and Collaborators
Medtronic Spinal and Biologics
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT00642876     History of Changes
Other Study ID Numbers: PRESTIGE®
First Posted: March 25, 2008    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Intervertebral Disc Displacement
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical