PRESTIGE® Cervical Disc Study

Degenerative Cervical Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642876
• Other study ID #: PRESTIGE®
• Status: Completed
• Phase: N/A
• Start date: October 2002
• Est. completion date: May 2013

Study information

• Verified date: May 2023
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The primary follow-up information obtained from this clinical investigation are used to support a PMA application for the ACD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 541
• Est. completion date: May 2013
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Cervical Disc Disease
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Atlanta Brain and Spine Care	Atlanta	Georgia
United States	Emory Orthop and Spine Center	Atlanta	Georgia
United States	Neurosurgery Ass, P.A.	Baltimore	Maryland
United States	Baton Rouge Orth Clinic	Baton Rouge	Louisiana
United States	Surgical Neurology New Hampshire Neurospine Institute	Bedford	New Hampshire
United States	Central Illinois Neuroscience	Bloomington	Illinois
United States	Central Wyoming Neurosurgery	Casper	Wyoming
United States	Wyoming Brain and Spine Institute	Casper	Wyoming
United States	Spine Surgery Associates	Chattanooga	Tennessee
United States	The Ortho Center of St. Louis	Chesterfield	Missouri
United States	Hughston Clinic	Columbus	Georgia
United States	Center of Neurosciences Orthopedics & Spine, P.C.	Dakota Dunes	South Dakota
United States	North Alabama Neurological	Huntsville	Alabama
United States	Orthoindy	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Westphal Group	Lancaster	Pennsylvania
United States	University of Wisconsin Medical School	Madison	Wisconsin
United States	Semmes Murphey	Memphis	Tennessee
United States	Montgomery Neurosurgical	Montgomery	Alabama
United States	Howell Allen Clinic	Nashville	Tennessee
United States	Loyola University Medical Center	Oak Park	Illinois
United States	Brain and Spine Center of Texas	Plano	Texas
United States	Oregon Health & Science University	Portland	Oregon
United States	Neurosugical Associates, PC	Richmond	Virginia
United States	University of California, Davis	Sacramento	California
United States	The Spine Institute	Santa Monica	California
United States	Inland Neurosurgery & Spine Associates, P.S.	Spokane	Washington
United States	Springfield Neurological Institute	Springfield	Missouri
United States	Buffalo Neurosurgery Group	West Seneca	New York
United States	Orlando Neurosurgery	Winter Park	Florida
United States	Michigan Brain & Spine Institute	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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