Clinical trial NCT00637156: Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels
Official title: A Prospective, Randomized, Controlled, Multicenter Pivotal Clinical Trial of the Artificial Cervical Disc-LP at Two Levels for Symptomatic Cervical Disc Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Degenerative Disc Disease
Radiculopathy
Myelopathy
Keywords: Symptomatic DDD at Two Adjacent Levels of cervical spine
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2008-03-17
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of Overall Success
timeFrame: 24 Months
Secondary outcomes:
measure: Success Rate of Neck Disability Index
timeFrame: 24 months
measure: Success Rate of Neurological Status
timeFrame: 24 months
measure: Neck Pain Success Rate
timeFrame: 24 months
measure: Arm Pain Success Rate
timeFrame: 24 months
measure: Success Rate of SF-36 PCS
timeFrame: 24 months
measure: Success Rate of SF-36 MCS
timeFrame: 24 months
measure: Rate of Disc Height Success
timeFrame: 24 months
measure: Gait Success Rate
timeFrame: 24 months
measure: Operative Time
timeFrame: Time of operation, an average of 1.7-2.1hrs
measure: Blood Loss
timeFrame: During the time of operation, an average of 1.7-2.1 hrs
measure: Hospital Stay
timeFrame: From admission to discharge, an average of 1.0-1.5 day
measure: Rate of Secondary Surgery at Index Level
timeFrame: 24 months
measure: Change of Neck Disability Index Score From Baseline
timeFrame: Baseline and 24 months post-operation
measure: Change of Neck Pain Score From Baseline
timeFrame: Baseline and 24 months post-operation
measure: Change of Arm Pain Score From Baseline
timeFrame: Baseline and 24 months post-operation
measure: Change of General Health Status -- SF-36 PCS From Baseline
timeFrame: Baseline and 24 months post-operation
measure: Change of General Health Status -- SF-36 MCS From Baseline
timeFrame: Baseline and 24 months post-operation
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: The Orthopaedic Center; Crestwood Medical Center
state: Alabama
city: Beverly Hills
country: United States
facility: Todd Lanman, MD, FACS, A Professional Corp.;
state: California
city: Colton
country: United States
facility: Bone & Spine Surgery
state: California
city: La Jolla
country: United States
facility: La Jolla Neurological Associates, AMC; Scripps Memorial Hospital La Jolla; Scripps Memorial Hospital Encinitas
state: California
city: San Francisco
country: United States
facility: St. Mary's Spine Center; St. Mary's Hospital
state: California
city: Newark
country: United States
facility: Delaware Neurosurgical Group; Christiana Care Health Systems
state: Delaware
city: Panama City
country: United States
facility: Spinal Associates, Gulf Coast Hospital
state: Florida
city: Atlanta
country: United States
facility: Peachtree Neurosurgery, Northside Hospital
state: Georgia
city: Columbus
country: United States
facility: The Hughston Clinic, P.C., Hughston Hospital and Rehabilitation Center
state: Georgia
city: Fort Wayne
country: United States
facility: Neuro Spine & Pain Center; Lutheran Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Grand Rapids
country: United States
facility: Great Lakes Neurosurgical; Spectrum Health East Campus
state: Michigan
city: Saginaw
country: United States
facility: Adams Neurosurgery; Mid Michigan Medical Center
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Chesterfield
country: United States
facility: The Orthopedic Center of St. Louis; Barnes Jewish West County Hospital
state: Missouri
city: Missoula
country: United States
facility: Montana Neuro Science Institute; St. Patrick's Medical Center
state: Montana
city: Buffalo
country: United States
facility: University at Buffalo Neurosurgery, Inc. Kaleida Health-Buffalo General Medical center/Gates Vascular Institute
state: New York
city: West Seneca
country: United States
facility: Buffalo Neurosurgery Group
state: New York
city: Akron
country: United States
facility: Crystal Clinic, Inc.; Akron General Medical Center
state: Ohio
city: Westerville
country: United States
facility: Central Ohio Neurological Surgeons; Mt. Carmel East Hospital
state: Ohio
city: Bend
country: United States
facility: The Center Orthopaedic & Neurosurgical Care & Research
state: Oregon
city: Allentown
country: United States
facility: OAA Orthopaedic Specialists
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Neurosurgery; Washington Hospital
state: Pennsylvania
city: West Columbia
country: United States
facility: Lexington Brain and Spine Institute
state: South Carolina
city: Chattanooga
country: United States
facility: Center for Sports Medicine and Orthopaedics; Memorial Hospital
state: Tennessee
city: Johnson City
country: United States
facility: East Tennessee Brain & Spine Center, Johnson City Medical Center
state: Tennessee
city: Austin
country: United States
facility: Central Texas Spine Institute; Health South Surgical Center
state: Texas
city: Winchester
country: United States
facility: Virginia Brain and Spine; Winchester Medical Center
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University; Ruby Memorial Hospital, WVU Hospitals, Inc.
state: West Virginia
Study officials:
affiliation: The Hughston Clinic, P.C.
name: John K Burkus, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.