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Degenerative Cervical Disc DiseaseNCT00642876

PRESTIGE® Cervical Disc Study

A study testing Allograft Fusion and ATLANTIS™ Cervical Plate System and PRESTIGE® Cervical Disc in people with Degenerative Cervical Disc Disease, run by Medtronic Spinal and Biologics at 31 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 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Degenerative Cervical Disc Disease
What is being tested?
Allograft Fusion and ATLANTIS™ Cervical Plate System and PRESTIGE® Cervical Disc
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
541 participants
Where
31 sitesUnited States
Study dates
Oct 2002to May 2013
Phase
Interventional
Are there results?
None posted in the registry

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

  • All patients participating in this study must meet all of the following inclusion criteria:
  • 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).
  • herniated disc;
  • osteophyte formation;
  • One cervical level requiring surgical treatment;
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  • C3-C4 disc to C6-C7 disc level of involvement;
  • 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;
  • No previous surgical intervention at the involved level or any subsequent, planned/staged surgical procedure at the involved or adjacent level(s);
  • Is at least 18 years of age, inclusive, at the time of surgery;
  • Preoperative Neck Disability Index score > or = 30;
  • Has a preoperative neck pain score of > 20 based on the Preoperative Neck and Arm Pain Questionnaire.
  • If of child-bearing potential, patient is not pregnant at the time of surgery;
  • Is willing to comply with the study plan and sign the Patient Informed Consent Form.

Who cannot join

  • A patient meeting any of the following criteria is to be excluded from the study:
  • Has a cervical spinal condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level;
  • Documented or diagnosed cervical instability defined by dynamic (flexion/extension) radiographs showing:
  • Sagittal plane translation > 3.5 mm or;
  • Sagittal plane angulation > 20.
  • More than one cervical level requiring surgical treatment;
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  • Has a fused level adjacent to the level to be treated;
  • Has severe pathology of the facet joints of the involved vertebral bodies;
  • Previous surgical intervention at the involved level;
  • Has been previously diagnosed with osteopenia or osteomalacia;
  • 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):
  • Postmenopausal Non-Black female over 60 years of age and weighs less than 140 pounds.
  • Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.
  • Male over the age of 70.
  • 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.
  • Has presence of spinal metastases;
  • Has overt or active bacterial infection, either local or systemic;
  • Has severe insulin dependent diabetes;
  • Has chronic or acute renal failure or prior history of renal disease;
  • Has fever (temperature > 101 F oral) at the time of surgery;
  • Has a documented allergy or intolerance to stainless steel, titanium, or a titanium alloy;
  • Is mentally incompetent. (If questionable, obtain psychiatric consult);
  • Is a prisoner;
  • Is pregnant;
  • Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse;
  • 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;
  • 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);
  • 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);
  • 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.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites

  • Atlanta Brain and Spine Care

    Atlanta, Georgia, 30309

  • Emory Orthop and Spine Center

    Atlanta, Georgia, 30329

  • Neurosurgery Ass, P.A.

    Baltimore, Maryland, 21237

  • Baton Rouge Orth Clinic

    Baton Rouge, Louisiana, 70810

  • Surgical Neurology New Hampshire Neurospine Institute

    Bedford, New Hampshire, 03110

  • Central Illinois Neuroscience

    Bloomington, Illinois, 61701

  • Central Wyoming Neurosurgery

    Casper, Wyoming, 82601

  • Wyoming Brain and Spine Institute

    Casper, Wyoming, 82601

  • Spine Surgery Associates

    Chattanooga, Tennessee, 37421

  • The Ortho Center of St. Louis

    Chesterfield, Missouri, 63017

  • Hughston Clinic

    Columbus, Georgia, 31908

  • Center of Neurosciences Orthopedics & Spine, P.C.

    Dakota Dunes, South Dakota, 57049

  • North Alabama Neurological

    Huntsville, Alabama, 35801

  • Orthoindy

    Indianapolis, Indiana, 46278

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Westphal Group

    Lancaster, Pennsylvania, 17601

  • University of Wisconsin Medical School

    Madison, Wisconsin, 53792

  • Semmes Murphey

    Memphis, Tennessee, 38104

  • Montgomery Neurosurgical

    Montgomery, Alabama, 36106

  • Howell Allen Clinic

    Nashville, Tennessee, 37203

  • Loyola University Medical Center

    Oak Park, Illinois, 60302

  • Brain and Spine Center of Texas

    Plano, Texas, 75093

  • Oregon Health & Science University

    Portland, Oregon, 97201

  • Neurosugical Associates, PC

    Richmond, Virginia, 23229

  • University of California, Davis

    Sacramento, California, 95816

  • The Spine Institute

    Santa Monica, California, 90403

  • Inland Neurosurgery & Spine Associates, P.S.

    Spokane, Washington, 99204

  • Springfield Neurological Institute

    Springfield, Missouri, 65807

  • Buffalo Neurosurgery Group

    West Seneca, New York, 14224

  • Orlando Neurosurgery

    Winter Park, Florida, 32789

  • Michigan Brain & Spine Institute

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: Investigation of the PRESTIGE® Cervical Disc Device at a Single Level for Symptomatic Cervical Disc Disease

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.

Being tested
Allograft Fusion and ATLANTIS™ Cervical Plate System, PRESTIGE® Cervical Disc

What participants receive

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

  • Allograft Fusion and ATLANTIS™ Cervical Plate SystemDevice

    Also called ATLANTIS™

    The patients that received the control treatment underwent a single level anterior cervical fusion procedure involving allograft bone and the ATLANTIS™ Cervical Plate System.

  • PRESTIGE® Cervical DiscDevice

    Also called PRESTIGE®

    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.

Study groups in NCT00642876
Study groupRoleWhat they receive
ControlActive comparatorThe Control cohort are patients that receive the fusion treatment.
Receives: Device: Allograft Fusion and ATLANTIS™ Cervical Plate System
InvestigationalExperimentalThe Investigational cohort are the study patients that received the PRESTIGE® Cervical Disc.
Receives: Device: PRESTIGE® Cervical Disc

What is being measured

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

  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

    Measured: 24 months

Secondary outcomes (1)

  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

    Measured: 24 months

Timeline

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

  1. First posted25 Mar 2008 (estimated)
  2. Study startOct 2002
  3. Primary completionJul 2006
  4. Study completionMay 2013

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
541 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00642876
Sponsor's protocol ID
PRESTIGE®
Status last verified
May 2023
First submitted
19 Mar 2008
Last updated
10 May 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Burkus JK, Haid RW, Traynelis VC, Mummaneni PV. Long-term clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: results from a prospective randomized controlled clinical trial. J Neurosurg Spine. 2010 Sep;13(3):308-18. doi: 10.3171/2010.3.SPINE09513.

    PubMed 20809722

  • Mummaneni PV, Burkus JK, Haid RW, Traynelis VC, Zdeblick TA. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine. 2007 Mar;6(3):198-209. doi: 10.3171/spi.2007.6.3.198.

    PubMed 17355018

  • Gornet MF, Lanman TH, Burkus JK, Hodges SD, McConnell JR, Dryer RF, Schranck FW, Copay AG. One-Level Versus 2-Level Treatment With Cervical Disc Arthroplasty or Fusion: Outcomes Up to 7 Years. Int J Spine Surg. 2019 Dec 31;13(6):551-560. doi: 10.14444/6076. eCollection 2019 Dec.

    PubMed 31970051

  • Arnold PM, Anderson KK, Selim A, Dryer RF, Kenneth Burkus J. Heterotopic ossification following single-level anterior cervical discectomy and fusion: results from the prospective, multicenter, historically controlled trial comparing allograft to an optimized dose of rhBMP-2. J Neurosurg Spine. 2016 Sep;25(3):292-302. doi: 10.3171/2016.1.SPINE15798. Epub 2016 Apr 29.

    PubMed 27129045

  • Burkus JK, Traynelis VC, Haid RW Jr, Mummaneni PV. Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial: Clinical article. J Neurosurg Spine. 2014 Oct;21(4):516-28. doi: 10.3171/2014.6.SPINE13996. Epub 2014 Jul 18.

    PubMed 25036218

Questions about this trial

What is this clinical trial studying?

A study testing Allograft Fusion and ATLANTIS™ Cervical Plate System and PRESTIGE® Cervical Disc in people with Degenerative Cervical Disc Disease, run by Medtronic Spinal and Biologics at 31 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 14 inclusion and 30 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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). 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 NCT00642876, which also lists 5 linked publications.

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 10 May 2023.

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