Clinical trial NCT00642876: PRESTIGE® Cervical Disc Study
Official title: Investigation of the PRESTIGE® Cervical Disc Device at a Single Level for Symptomatic Cervical Disc Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Cervical Disc Disease
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 541
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
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
timeFrame: 24 months
Secondary outcomes:
measure: 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
timeFrame: 24 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: North Alabama Neurological
state: Alabama
city: Montgomery
country: United States
facility: Montgomery Neurosurgical
state: Alabama
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: Santa Monica
country: United States
facility: The Spine Institute
state: California
city: Winter Park
country: United States
facility: Orlando Neurosurgery
state: Florida
city: Atlanta
country: United States
facility: Atlanta Brain and Spine Care
state: Georgia
city: Atlanta
country: United States
facility: Emory Orthop and Spine Center
state: Georgia
city: Columbus
country: United States
facility: Hughston Clinic
state: Georgia
city: Bloomington
country: United States
facility: Central Illinois Neuroscience
state: Illinois
city: Oak Park
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Orthoindy
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Baton Rouge
country: United States
facility: Baton Rouge Orth Clinic
state: Louisiana
city: Baltimore
country: United States
facility: Neurosurgery Ass, P.A.
state: Maryland
city: Ypsilanti
country: United States
facility: Michigan Brain & Spine Institute
state: Michigan
city: Chesterfield
country: United States
facility: The Ortho Center of St. Louis
state: Missouri
city: Springfield
country: United States
facility: Springfield Neurological Institute
state: Missouri
city: Bedford
country: United States
facility: Surgical Neurology New Hampshire Neurospine Institute
state: New Hampshire
city: West Seneca
country: United States
facility: Buffalo Neurosurgery Group
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Lancaster
country: United States
facility: Westphal Group
state: Pennsylvania
city: Dakota Dunes
country: United States
facility: Center of Neurosciences Orthopedics & Spine, P.C.
state: South Dakota
city: Chattanooga
country: United States
facility: Spine Surgery Associates
state: Tennessee
city: Memphis
country: United States
facility: Semmes Murphey
state: Tennessee
city: Nashville
country: United States
facility: Howell Allen Clinic
state: Tennessee
city: Plano
country: United States
facility: Brain and Spine Center of Texas
state: Texas
city: Richmond
country: United States
facility: Neurosugical Associates, PC
state: Virginia
city: Spokane
country: United States
facility: Inland Neurosurgery & Spine Associates, P.S.
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Medical School
state: Wisconsin
city: Casper
country: United States
facility: Central Wyoming Neurosurgery
state: Wyoming
city: Casper
country: United States
facility: Wyoming Brain and Spine Institute
state: Wyoming
Study officials:
References:
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.