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

Not Applicable

Completed

Conditions: Myelopathy
Cervical Degenerative Disc Disease
Radiculopathy

Interventions: Device: PRESTIGE LP device at two adjacent levels
Device: Bi-level fusion with ATLANTIS Cervical Plate System

Registration Number: NCT00637156

Lead Sponsor: Medtronic Spinal and Biologics

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 397

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels	-
ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System	-

Primary Outcome Measures

Name	Time	Method
Rate of Overall Success	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 Outcome Measures

Name	Time	Method
Success Rate of Neck Disability Index	24 months	Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15.
Success Rate of Neurological Status	24 months	Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must either remain the same or improve from the time of the preoperative evaluation to the time period evaluated.
Neck Pain Success Rate	24 months	Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met the following criterion: Preoperative Score - Postoperative Score \> 0.
Arm Pain Success Rate	24 months	Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met the following criterion: Preoperative Score - Postoperative Score \> 0.
Success Rate of SF-36 PCS	24 months	Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score \>= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.
Success Rate of SF-36 MCS	24 months	Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score \>= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.
Rate of Disc Height Success	24 months	Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height \>= -2mm
Gait Success Rate	24 months	Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score \>= 0. The gait success rate is reported as the percentage of participants who had gait success.
Operative Time	Time of operation, an average of 1.7-2.1hrs	Operative time was recorded from skin incision to wound closure.
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	Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of subjects who had secondary surgeries at index level.
Change of Neck Disability Index Score From Baseline	Baseline and 24 months post-operation	The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.
Change of Neck Pain Score From Baseline	Baseline and 24 months post-operation	Numerical rating scales were used to evaluate neck pain intensity and frequency. Subjects rated their neck pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their neck pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total neck pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline.
Change of Arm Pain Score From Baseline	Baseline and 24 months post-operation	Numerical rating scales were also used to evaluate arm pain intensity and frequency. Subjects rated their arm pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their arm pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total arm pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline.
Change of General Health Status -- SF-36 PCS From Baseline	Baseline and 24 months post-operation	The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.
Change of General Health Status -- SF-36 MCS From Baseline	Baseline and 24 months post-operation	The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.

Trial Locations

Locations (29): Center for Sports Medicine and Orthopaedics; Memorial Hospital
🇺🇸
Chattanooga, Tennessee, United States
Lexington Brain and Spine Institute
🇺🇸
West Columbia, South Carolina, United States
West Virginia University; Ruby Memorial Hospital, WVU Hospitals, Inc.
🇺🇸
Morgantown, West Virginia, United States
Delaware Neurosurgical Group; Christiana Care Health Systems
🇺🇸
Newark, Delaware, United States
St. Mary's Spine Center; St. Mary's Hospital
🇺🇸
San Francisco, California, United States
Neuro Spine & Pain Center; Lutheran Hospital
🇺🇸
Fort Wayne, Indiana, United States
Montana Neuro Science Institute; St. Patrick's Medical Center
🇺🇸
Missoula, Montana, United States
Adams Neurosurgery; Mid Michigan Medical Center
🇺🇸
Saginaw, Michigan, United States
The Orthopedic Center of St. Louis; Barnes Jewish West County Hospital
🇺🇸
Chesterfield, Missouri, United States
OAA Orthopaedic Specialists
🇺🇸
Allentown, Pennsylvania, United States
Allegheny Neurosurgery; Washington Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Todd Lanman, MD, FACS, A Professional Corp.;
🇺🇸
Beverly Hills, California, United States
University of Iowa Hospitals & Clinics
🇺🇸
Iowa City, Iowa, United States
Bone & Spine Surgery
🇺🇸
Colton, California, United States
Spinal Associates, Gulf Coast Hospital
🇺🇸
Panama City, Florida, United States
Peachtree Neurosurgery, Northside Hospital
🇺🇸
Atlanta, Georgia, United States
Buffalo Neurosurgery Group
🇺🇸
West Seneca, New York, United States
Great Lakes Neurosurgical; Spectrum Health East Campus
🇺🇸
Grand Rapids, Michigan, United States
Central Ohio Neurological Surgeons; Mt. Carmel East Hospital
🇺🇸
Westerville, Ohio, United States
The Center Orthopaedic & Neurosurgical Care & Research
🇺🇸
Bend, Oregon, United States
University at Buffalo Neurosurgery, Inc. Kaleida Health-Buffalo General Medical center/Gates Vascular Institute
🇺🇸
Buffalo, New York, United States
La Jolla Neurological Associates, AMC; Scripps Memorial Hospital La Jolla; Scripps Memorial Hospital Encinitas
🇺🇸
La Jolla, California, United States
The Orthopaedic Center; Crestwood Medical Center
🇺🇸
Huntsville, Alabama, United States
Henry Ford Hospital
🇺🇸
West Bloomfield, Michigan, United States
The Hughston Clinic, P.C., Hughston Hospital and Rehabilitation Center
🇺🇸
Columbus, Georgia, United States
Crystal Clinic, Inc.; Akron General Medical Center
🇺🇸
Akron, Ohio, United States
Virginia Brain and Spine; Winchester Medical Center
🇺🇸
Winchester, Virginia, United States
Central Texas Spine Institute; Health South Surgical Center
🇺🇸
Austin, Texas, United States
East Tennessee Brain & Spine Center, Johnson City Medical Center
🇺🇸
Johnson City, Tennessee, United States