Clinical trial NCT00667459: Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD
Official title: A Prospective, Multicenter, Controlled Clinical Trial of an Artificial Cervical Disc LP at a Single Level for Symptomatic Cervical Disc Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Degenerative Disc Disease
Keywords: Cervical Disc
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at a single level from C3-C4 to C6-C7.

Detailed description: This pivotal clinical trial was conducted to compare treatment data of the investigational implant device,the PRESTIGE® LP Cervical Disc, with a control patient group receiving a plate. The PRESTIGE® LP Cervical Disc devices were implanted using an anterior surgical approach. Data from control patients receiving anterior cervical discectomy and fusion with an ATLANTIS Anterior Cervical Plate from the initial Artificial Cervical Disc study (NCT00642876) were compared as both treatment groups receive single-level surgical treatment from C3-C4 to C6-C7 for symptomatic cervical degenerative disc disease.

Eligibility criteria: Inclusion Criteria:

* Has cervical degenerative disc disease as defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression that is documented by patient history: a) herniated disc; b) osteophyte formation
* One level requiring surgical treatment
* C3-C4 disc to C6-C7 disc level involvement
* Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or signs of cord compression
* No previous surgical procedures at the involved level or any planned surgical procedure at the involved or adjacent level.
* Preop Neck Disability index score ≥ 30
* Preop Neck Pain score of ≥ 20 based on the Preop Neck \& Arm Pain Questionnaire
* Not pregnant at time of surgery
* Willing and able to comply with study plan and able to understand and sign patient informed consent

Exclusion Criteria:

* Any other cervical spinal condition requiring surgical treatment at the involved level
* Documented or diagnosed cervical instability defined by radiographs showing

  1. Sagittal plane translation \> 3.5mm or
  2. Sagittal plane angulation \> 20 degrees.
* More than one cervical level requiring surgery
* A fused level adjacent to the level to be treated
* Severe pathology of the facet joint of involved bodies
* Previous surgery at the involved level
* Previously diagnosed osteopenia or osteomalacia
* Any of the following that may be associated with an osteoporosis diagnosis (if "Yes" to any of these, a DEXA Scan will be required to determine eligibility)

  1. Postmenopausal non-Black female over 60 years of age and weighs less than 140 pounds
  2. Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture
  3. Male over the age of 70
  4. Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.

If the level of Bone Mineral Density is a T score of -3.5 or lower or a T score of -2.5 or lower with the vertebral crush fracture, then the patient is excluded.

* Presence of spinal metastases
* Overt or active bacterial infection, either local or systemic
* Severe insulin dependent diabetes
* Chronic or acute renal failure or history of renal disease
* Temperature \> 101º F oral at surgery
* Documented allergy to stainless steel, titanium or a titanium alloy
* Mentally incompetent
* Is a prisoner
* Is pregnant
* Is an alcohol and/or drug abuser
* Has received drugs which may interfere with bone metabolism within 2 weeks prior to the planned surgery date (steroids, methotrexate), excluding routine preop anti-inflammatories)
* A history of endocrine or metabolic disorder known to affect osteogenesis
* A condition that requires postop medications that interfere with the stability of the implant (steroids). This does not include low dose aspirin therapy.
* Received treatment with an investigational therapy within 28 days prior to surgery or planned for 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: Rate of Disc Height Success
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: Gait Success Rate
timeFrame: 24 months
measure: Operative Time
timeFrame: Time of operation, approximately 1.5 hrs.
measure: Blood Loss
timeFrame: During the time of operation, approximately 1.5 hours.
measure: Hospital Stay
timeFrame: During the time of hospital stay, average of 1 day.
measure: Rate of Secondary Surgery at Index Level
timeFrame: 24 months post-operation
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: Atlanta
country: United States
facility: Emory Orthopaedics and Spine Center
state: Georgia
city: Columbus
country: United States
facility: The Hughston Clinic, P.C.
state: Georgia
city: Coeur d'Alene
country: United States
facility: Coeur d'Alene Spine and Brain, PLLC
state: Idaho
city: Bloomington
country: United States
facility: Central Illinois Neuroscience
state: Illinois
city: Carmel
country: United States
facility: Indiana Spine
state: Indiana
city: Indianapolis
country: United States
facility: OrthoIndy
state: Indiana
city: Cedar Rapids
country: United States
facility: Cedar Neurological Surgeons, PC
state: Iowa
city: Peabody
country: United States
facility: Sports Medicine North
state: Massachusetts
city: Chesterfield
country: United States
facility: The Orthopaedic Center of St. Louis
state: Missouri
city: Springfield
country: United States
facility: Springfield Neurological Institute
state: Missouri
city: West Seneca
country: United States
facility: Buffalo Neurosurgery Group
state: New York
city: Eugene
country: United States
facility: NeuroSpine Institute, LLC
state: Oregon
city: Charleston
country: United States
facility: Clinical Trials for South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Orthopaedic Group
state: Tennessee
city: Plano
country: United States
facility: Brain and Spine Center of Texas, L.L.P.
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia,Neurosurgery Department
state: Virginia
Study officials:
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, Burkus JK, Shaffrey ME, Schranck FW, Copay AG. Cervical disc arthroplasty: 10-year outcomes of the Prestige LP cervical disc at a single level. J Neurosurg Spine. 2019 May 10;31(3):317-325. doi: 10.3171/2019.2.SPINE1956. Print 2019 Sep 1.
citation: Gornet MF, Burkus JK, Shaffrey ME, Nian H, Harrell FE Jr. Cervical Disc Arthroplasty with Prestige LP Disc Versus Anterior Cervical Discectomy and Fusion: Seven-Year Outcomes. Int J Spine Surg. 2016 Jun 22;10:24. doi: 10.14444/3024. eCollection 2016.