PRESTIGE® Cervical Disc Study

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Cervical Disc Disease
• Intervention / Treatment: Device: Allograft Fusion and ATLANTIS™ Cervical Plate System; Device: PRESTIGE® Cervical Disc

• Study Type: Interventional
• Enrollment (Actual): 541
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • North Alabama Neurological
    • Montgomery, Alabama, United States, 36106
      • Montgomery Neurosurgical
  • California
    • Sacramento, California, United States, 95816
      • University of California, Davis
    • Santa Monica, California, United States, 90403
      • The Spine Institute
  • Florida
    • Winter Park, Florida, United States, 32789
      • Orlando Neurosurgery
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Atlanta Brain and Spine Care
    • Atlanta, Georgia, United States, 30329
      • Emory Orthop and Spine Center
    • Columbus, Georgia, United States, 31908
      • Hughston Clinic
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Central Illinois Neuroscience
    • Oak Park, Illinois, United States, 60302
      • Loyola University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46278
      • OrthoIndy
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70810
      • Baton Rouge Orth Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Neurosurgery Ass, P.A.
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Michigan Brain & Spine Institute
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • The Ortho Center of St. Louis
    • Springfield, Missouri, United States, 65807
      • Springfield Neurological Institute
  • New Hampshire
    • Bedford, New Hampshire, United States, 03110
      • Surgical Neurology New Hampshire Neurospine Institute
  • New York
    • West Seneca, New York, United States, 14224
      • Buffalo Neurosurgery Group
  • Oregon
    • Portland, Oregon, United States, 97201
      • Oregon Health & Science University
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17601
      • Westphal Group
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57049
      • Center of Neurosciences Orthopedics & Spine, P.C.
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Spine Surgery Associates
    • Memphis, Tennessee, United States, 38104
      • Semmes Murphey
    • Nashville, Tennessee, United States, 37203
      • Howell Allen Clinic
  • Texas
    • Plano, Texas, United States, 75093
      • Brain and Spine Center of Texas
  • Virginia
    • Richmond, Virginia, United States, 23229
      • Neurosugical Associates, PC
  • Washington
    • Spokane, Washington, United States, 99204
      • Inland Neurosurgery & Spine Associates, P.S.
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Medical School
  • Wyoming
    • Casper, Wyoming, United States, 82601
      • Central Wyoming Neurosurgery
    • Casper, Wyoming, United States, 82601
      • Wyoming Brain and Spine Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: PRESTIGE®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Medtronic Spinal and Biologics

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: March 19, 2008
• First Submitted That Met QC Criteria: March 24, 2008
• First Posted (Estimate): March 25, 2008

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Intervertebral Disc Degeneration
• Other Study ID Numbers: PRESTIGE®