A Prospective, Randomized, Controlled, Multicenter Pivotal Clinical Trial of the Artificial Cervical Disc-LP at Two Levels for Symptomatic Cervical Disc Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Degenerative Disc Disease
- Sponsor
- Medtronic Spinal and Biologics
- Enrollment
- 397
- Locations
- 29
- Primary Endpoint
- Rate of Overall Success
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 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.
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 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Rate of Overall Success
Time Frame: 24 Months
Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative; 2. Maintenance or improvement in neurological status; 3. No serious adverse event classified as implant associated or implant/surgical procedure associated; and 4. No additional surgical procedure classified as a "failure."
Secondary Outcomes
- Success Rate of Neck Disability Index(24 months)
- Success Rate of Neurological Status(24 months)
- Neck Pain Success Rate(24 months)
- Arm Pain Success Rate(24 months)
- Success Rate of SF-36 PCS(24 months)
- Success Rate of SF-36 MCS(24 months)
- Rate of Disc Height Success(24 months)
- Gait Success Rate(24 months)
- Operative Time(Time of operation, an average of 1.7-2.1hrs)
- Blood Loss(During the time of operation, an average of 1.7-2.1 hrs)
- Hospital Stay(From admission to discharge, an average of 1.0-1.5 day)
- Rate of Secondary Surgery at Index Level(24 months)
- Change of Neck Disability Index Score From Baseline(Baseline and 24 months post-operation)
- Change of Neck Pain Score From Baseline(Baseline and 24 months post-operation)
- Change of Arm Pain Score From Baseline(Baseline and 24 months post-operation)
- Change of General Health Status -- SF-36 PCS From Baseline(Baseline and 24 months post-operation)
- Change of General Health Status -- SF-36 MCS From Baseline(Baseline and 24 months post-operation)