PRESTIGE® Cervical Disc Study

NCT00642876 | Completed DMC

• 1 other identifier: PRESTIGE®
• Study Type: interventional
• Target: 541
• Locations: 1 country
• Sites: 31

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.

Conditions

Degenerative Cervical Disc Disease

Outcome Measures

Primary Outcomes (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

  24 months

Secondary Outcomes (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

  24 months

Study Arms (2)

Control

ACTIVE COMPARATOR

The Control cohort are patients that receive the fusion treatment.

Device: Allograft Fusion and ATLANTIS™ Cervical Plate System

Investigational

EXPERIMENTAL

The Investigational cohort are the study patients that received the PRESTIGE® Cervical Disc.

Device: PRESTIGE® Cervical Disc

Interventions

Allograft Fusion and ATLANTIS™ Cervical Plate System DEVICE

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

Also known as: ATLANTIS™

Control

PRESTIGE® Cervical Disc DEVICE

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.

Also known as: PRESTIGE®

Investigational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (31)

North Alabama Neurological

Huntsville, Alabama, 35801, United States

Location

Montgomery Neurosurgical

Montgomery, Alabama, 36106, United States

Location

University of California, Davis

Sacramento, California, 95816, United States

Location

The Spine Institute

Santa Monica, California, 90403, United States

Location

Orlando Neurosurgery

Winter Park, Florida, 32789, United States

Location

Atlanta Brain and Spine Care

Atlanta, Georgia, 30309, United States

Location

Emory Orthop and Spine Center

Atlanta, Georgia, 30329, United States

Location

Hughston Clinic

Columbus, Georgia, 31908, United States

Location

Central Illinois Neuroscience

Bloomington, Illinois, 61701, United States

Location

Loyola University Medical Center

Oak Park, Illinois, 60302, United States

Location

Orthoindy

Indianapolis, Indiana, 46278, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Baton Rouge Orth Clinic

Baton Rouge, Louisiana, 70810, United States

Location

Neurosurgery Ass, P.A.

Baltimore, Maryland, 21237, United States

Location

Michigan Brain & Spine Institute

Ypsilanti, Michigan, 48197, United States

Location

The Ortho Center of St. Louis

Chesterfield, Missouri, 63017, United States

Location

Springfield Neurological Institute

Springfield, Missouri, 65807, United States

Location

Surgical Neurology New Hampshire Neurospine Institute

Bedford, New Hampshire, 03110, United States

Location

Buffalo Neurosurgery Group

West Seneca, New York, 14224, United States

Location

Oregon Health & Science University

Portland, Oregon, 97201, United States

Location

Westphal Group

Lancaster, Pennsylvania, 17601, United States

Location

Center of Neurosciences Orthopedics & Spine, P.C.

Dakota Dunes, South Dakota, 57049, United States

Location

Spine Surgery Associates

Chattanooga, Tennessee, 37421, United States

Location

Semmes Murphey

Memphis, Tennessee, 38104, United States

Location

Howell Allen Clinic

Nashville, Tennessee, 37203, United States

Location

Brain and Spine Center of Texas

Plano, Texas, 75093, United States

Location

Neurosugical Associates, PC

Richmond, Virginia, 23229, United States

Location

Inland Neurosurgery & Spine Associates, P.S.

Spokane, Washington, 99204, United States

Location

University of Wisconsin Medical School

Madison, Wisconsin, 53792, United States

Location

Central Wyoming Neurosurgery

Casper, Wyoming, 82601, United States

Location

Wyoming Brain and Spine Institute

Casper, Wyoming, 82601, United States

Location

Related Publications (5)

• 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.

  PMID: 20809722 BACKGROUND

• 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.

  PMID: 17355018 BACKGROUND

• 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.

  PMID: 31970051 DERIVED

• 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.

  PMID: 27129045 DERIVED

• 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.

  PMID: 25036218 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 25, 2008
• Study Start: October 1, 2002
• Primary Completion: July 1, 2006
• Study Completion: May 1, 2013
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

US (31)