Status:
COMPLETED
Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Cervical Degenerative Disc Disease
Radiculopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 adja...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT00637156
Start Date
June 1 2006
End Date
February 1 2018
Last Update
May 1 2018
Active Locations (29)
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1
The Orthopaedic Center; Crestwood Medical Center
Huntsville, Alabama, United States, 35801
2
Todd Lanman, MD, FACS, A Professional Corp.;
Beverly Hills, California, United States, 90210
3
Bone & Spine Surgery
Colton, California, United States, 92324
4
La Jolla Neurological Associates, AMC; Scripps Memorial Hospital La Jolla; Scripps Memorial Hospital Encinitas
La Jolla, California, United States, 92037