Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels

Medtronic

Status

Completed

Conditions

Radiculopathy

Myelopathy

Cervical Degenerative Disc Disease

Treatments

Device: PRESTIGE LP device at two adjacent levels

Device: Bi-level fusion with ATLANTIS Cervical Plate System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00637156

PRESTIGE LP Two Level Study

Details and patient eligibility

About

The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical spine, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will also be examined as the secondary objective.

Full description

This clinical investigation is being conducted to evaluate the PRESTIGE-LP device's performance at two adjacent cervical levels (C3-C7) in the treatment of patients with symptomatic degenerative disc disease. One-half of the patients in this randomized pivotal clinical trial will be treated at two adjacent cervical levels with the PRESTIGE-LP device. The remaining patients will receive a bi-level anterior cervical discectomy and fusion with cortical ring allografts and the ATLANTIS Cervical Plate System.

Enrollment

397 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Has cervical DDD at 2 adjacent cervical levels (C3-C7) requiring surgical treatment & involving intractable radiculopathy, myelopathy, or both
Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history, and the requirement for surgical treatment is evidenced by radiographic studies
Unresponsive to non-operative treatment for approximately 6 weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management
Has no previous surgical intervention at the involved levels or any subsequent planned/staged surgical procedure at the involved or adjacent level(s)
Must be ≥ 18 years; skeletally mature at time of surgery
Preoperative NDI score ≥ 30
Preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire
If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period
Is willing to comply with the study plan and sign Patient Informed Consent Form

Exclusion criteria

Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels
Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing: Sagittal plane translation > 3.5 mm, or Sagittal plane angulation > 20 degrees.
Has more than two cervical levels requiring surgical treatment
Has a fused level adjacent to the levels to be treated
Has severe pathology of the facet joints of the involved vertebral bodies
Has had previous surgical intervention at either one or both of the involved levels or at adjacent levels
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 a DEXA Scan will be required to determine eligibility.)
- Postmenopausal non-Black female over age of 60 who weighs < 140 pounds
- Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture
- Male > 70 years
- Male > 60 years who has sustained a non-traumatic hip or spine fracture
- If the level of BMD is a T score of -3.5 or lower or a T score of -2.5 or lower 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 insulin dependent diabetes
Is a tobacco user who does not agree to suspend smoking prior to surgery
Has chronic or acute renal failure or prior history of renal disease
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
Is involved with current or pending litigation regarding a spinal condition
Has received drugs that 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, 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 the 16 weeks following implantation