Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels
A Prospective, Randomized, Controlled, Multicenter Pivotal Clinical Trial of the Artificial Cervical Disc-LP at Two Levels for Symptomatic Cervical Disc Disease
1 other identifier
interventional
397
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2006
Longer than P75 for not_applicable
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 3, 2008
CompletedFirst Posted
Study publicly available on registry
March 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedResults Posted
Study results publicly available
November 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedMay 1, 2018
October 1, 2017
4.6 years
March 3, 2008
August 2, 2016
April 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Overall Success
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."
24 Months
Secondary Outcomes (17)
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
- +12 more secondary outcomes
Study Arms (2)
PRESTIGE LP Device
EXPERIMENTALATLANTIS Cervical Plate System
OTHERInterventions
PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
The Orthopaedic Center; Crestwood Medical Center
Huntsville, Alabama, 35801, United States
Todd Lanman, MD, FACS, A Professional Corp.;
Beverly Hills, California, 90210, United States
Bone & Spine Surgery
Colton, California, 92324, United States
La Jolla Neurological Associates, AMC; Scripps Memorial Hospital La Jolla; Scripps Memorial Hospital Encinitas
La Jolla, California, 92037, United States
St. Mary's Spine Center; St. Mary's Hospital
San Francisco, California, 94117, United States
Delaware Neurosurgical Group; Christiana Care Health Systems
Newark, Delaware, 19713, United States
Spinal Associates, Gulf Coast Hospital
Panama City, Florida, 32405, United States
Peachtree Neurosurgery, Northside Hospital
Atlanta, Georgia, 30342, United States
The Hughston Clinic, P.C., Hughston Hospital and Rehabilitation Center
Columbus, Georgia, 31908, United States
Neuro Spine & Pain Center; Lutheran Hospital
Fort Wayne, Indiana, 46804, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
Great Lakes Neurosurgical; Spectrum Health East Campus
Grand Rapids, Michigan, 49505, United States
Adams Neurosurgery; Mid Michigan Medical Center
Saginaw, Michigan, 48604, United States
Henry Ford Hospital
West Bloomfield, Michigan, 48322, United States
The Orthopedic Center of St. Louis; Barnes Jewish West County Hospital
Chesterfield, Missouri, 63017, United States
Montana Neuro Science Institute; St. Patrick's Medical Center
Missoula, Montana, 59802, United States
University at Buffalo Neurosurgery, Inc. Kaleida Health-Buffalo General Medical center/Gates Vascular Institute
Buffalo, New York, 14203, United States
Buffalo Neurosurgery Group
West Seneca, New York, 14224, United States
Crystal Clinic, Inc.; Akron General Medical Center
Akron, Ohio, 44333, United States
Central Ohio Neurological Surgeons; Mt. Carmel East Hospital
Westerville, Ohio, 43081, United States
The Center Orthopaedic & Neurosurgical Care & Research
Bend, Oregon, 97701, United States
OAA Orthopaedic Specialists
Allentown, Pennsylvania, 18104, United States
Allegheny Neurosurgery; Washington Hospital
Pittsburgh, Pennsylvania, 15212, United States
Lexington Brain and Spine Institute
West Columbia, South Carolina, 29169, United States
Center for Sports Medicine and Orthopaedics; Memorial Hospital
Chattanooga, Tennessee, 37404, United States
East Tennessee Brain & Spine Center, Johnson City Medical Center
Johnson City, Tennessee, 37604, United States
Central Texas Spine Institute; Health South Surgical Center
Austin, Texas, 78731, United States
Virginia Brain and Spine; Winchester Medical Center
Winchester, Virginia, 22601, United States
West Virginia University; Ruby Memorial Hospital, WVU Hospitals, Inc.
Morgantown, West Virginia, 26506, United States
Related Publications (4)
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.
PMID: 31970051DERIVEDGornet MF, Lanman TH, Burkus JK, Dryer RF, McConnell JR, Hodges SD, Schranck FW. Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial. J Neurosurg Spine. 2019 Jun 21;31(4):508-518. doi: 10.3171/2019.4.SPINE19157. Print 2019 Oct 1.
PMID: 31226684DERIVEDLanman TH, Burkus JK, Dryer RG, Gornet MF, McConnell J, Hodges SD. Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial. J Neurosurg Spine. 2017 Jul;27(1):7-19. doi: 10.3171/2016.11.SPINE16746. Epub 2017 Apr 7.
PMID: 28387616DERIVEDGornet MF, Lanman TH, Burkus JK, Hodges SD, McConnell JR, Dryer RF, Copay AG, Nian H, Harrell FE Jr. Cervical disc arthroplasty with the Prestige LP disc versus anterior cervical discectomy and fusion, at 2 levels: results of a prospective, multicenter randomized controlled clinical trial at 24 months. J Neurosurg Spine. 2017 Jun;26(6):653-667. doi: 10.3171/2016.10.SPINE16264. Epub 2017 Mar 17.
PMID: 28304237DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Department
- Organization
- Medtronic Spine and biologics
Study Officials
- PRINCIPAL INVESTIGATOR
John K Burkus, M.D.
The Hughston Clinic, P.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2008
First Posted
March 17, 2008
Study Start
June 1, 2006
Primary Completion
January 1, 2011
Study Completion
February 1, 2018
Last Updated
May 1, 2018
Results First Posted
November 18, 2016
Record last verified: 2017-10