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

NCT ID: NCT00637156

Last Updated: 2018-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 397 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2018-02-01

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.

Conditions

Cervical Degenerative Disc Disease; Radiculopathy; Myelopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRESTIGE LP Device

Group Type: EXPERIMENTAL

PRESTIGE LP device at two adjacent levels

Intervention Type: DEVICE

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.

ATLANTIS Cervical Plate System

Group Type: OTHER

Bi-level fusion with ATLANTIS Cervical Plate System

Intervention Type: DEVICE

Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Interventions

PRESTIGE LP device at two adjacent levels

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.

Intervention Type: DEVICE

Bi-level fusion with ATLANTIS Cervical Plate System

Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Intervention Type: DEVICE

Other Intervention Names

disc; artificial disc; cervical disc; plate; cervical plate; fusion; cervical fusion

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Spinal and Biologics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John K Burkus, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Hughston Clinic, P.C.

Locations

The Orthopaedic Center; Crestwood Medical Center

Huntsville, Alabama, United States

Todd Lanman, MD, FACS, A Professional Corp.;

Beverly Hills, California, United States

Bone & Spine Surgery

Colton, California, United States

La Jolla Neurological Associates, AMC; Scripps Memorial Hospital La Jolla; Scripps Memorial Hospital Encinitas

La Jolla, California, United States

St. Mary's Spine Center; St. Mary's Hospital

San Francisco, California, United States

Delaware Neurosurgical Group; Christiana Care Health Systems

Newark, Delaware, United States

Spinal Associates, Gulf Coast Hospital

Panama City, Florida, United States

Peachtree Neurosurgery, Northside Hospital

Atlanta, Georgia, United States

The Hughston Clinic, P.C., Hughston Hospital and Rehabilitation Center

Columbus, Georgia, United States

Neuro Spine & Pain Center; Lutheran Hospital

Fort Wayne, Indiana, United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Great Lakes Neurosurgical; Spectrum Health East Campus

Grand Rapids, Michigan, United States

Adams Neurosurgery; Mid Michigan Medical Center

Saginaw, Michigan, United States

Henry Ford Hospital

West Bloomfield, Michigan, United States

The Orthopedic Center of St. Louis; Barnes Jewish West County Hospital

Chesterfield, Missouri, United States

Montana Neuro Science Institute; St. Patrick's Medical Center

Missoula, Montana, United States

University at Buffalo Neurosurgery, Inc. Kaleida Health-Buffalo General Medical center/Gates Vascular Institute

Buffalo, New York, United States

Buffalo Neurosurgery Group

West Seneca, New York, United States

Crystal Clinic, Inc.; Akron General Medical Center

Akron, Ohio, United States

Central Ohio Neurological Surgeons; Mt. Carmel East Hospital

Westerville, Ohio, United States

The Center Orthopaedic & Neurosurgical Care & Research

Bend, Oregon, United States

OAA Orthopaedic Specialists

Allentown, Pennsylvania, United States

Allegheny Neurosurgery; Washington Hospital

Pittsburgh, Pennsylvania, United States

Lexington Brain and Spine Institute

West Columbia, South Carolina, United States

Center for Sports Medicine and Orthopaedics; Memorial Hospital

Chattanooga, Tennessee, United States

East Tennessee Brain & Spine Center, Johnson City Medical Center

Johnson City, Tennessee, United States

Central Texas Spine Institute; Health South Surgical Center

Austin, Texas, United States

Virginia Brain and Spine; Winchester Medical Center

Winchester, Virginia, United States

West Virginia University; Ruby Memorial Hospital, WVU Hospitals, Inc.

Morgantown, West Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31970051 (View on PubMed)

Gornet 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.

Reference Type: DERIVED

PMID: 31226684 (View on PubMed)

Lanman 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.

Reference Type: DERIVED

PMID: 28387616 (View on PubMed)

Gornet 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.

Reference Type: DERIVED

PMID: 28304237 (View on PubMed)

Other Identifiers

PRESTIGE LP Two Level Study

Identifier Type: -

Identifier Source: org_study_id