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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT00637156
First received: March 3, 2008
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Cervical Degenerative Disc Disease
Radiculopathy
Myelopathy
Device: PRESTIGE LP device at two adjacent levels
Device: Bi-level fusion with ATLANTIS Cervical Plate System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Multicenter Pivotal Clinical Trial of the Artificial Cervical Disc-LP at Two Levels for Symptomatic Cervical Disc Disease

Resource links provided by NLM:


Further study details as provided by Medtronic Spinal and Biologics:

Primary Outcome Measures:
  • Overall Success [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]

    A patient will be considered an overall success if all of the following conditions are met:

    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:
  • Pain/Disability Success [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The self-administered Neck Disability Index Questionnaire will be used. Success will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score ≥ 15

  • Neurological Status [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Neurological status is based on motor function, sensory function, and reflexes. Each of the categories is comprised of a number of elements.Success will be defined as maintenance or improvement in each element for the time period evaluated.

  • Pain Status (Neck Pain and Arm Pain) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Numerical rating scales will be used to evaluate pain intensity and duration. The pain score (0 min, 20 Max) is 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 duration 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"). Success for arm and neck pain is described as follows: Preoperative Score - Postoperative Score >0

  • General Health Status [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) are used to assess general health status. The SF-36 results can be summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). To be classified as a success for each component summary, the criteria must be met: PCSPostop - PCSPreop >= 0; MCSPostop - MCSPreop >= 0

  • Disc Height [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    Disc height will be assessed by determining the Functional Spinal Unit (FSU) height. The disc height success for each level is based on either the anterior or posterior measurements meeting the following criterion:

    Postoperative Height - 6 Week Postoperative Height >= -2mm


  • Additional Surgical Procedures/Interventions [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Gait Assessment (Nurick's Classification) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Patient's gait will be assessed by using Nurick's classification, and will be indicated either as normal or graded on a scale of 0 to 5. Success will be defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0

  • Surgery and Hospitalization Information [ Time Frame: At the time of discharge ] [ Designated as safety issue: No ]
    Surgery and hospitalization information includes operative time, blood loss, and number of hospital days.


Enrollment: 397
Study Start Date: June 2006
Estimated Study Completion Date: March 2015
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRESTIGE LP Device Device: 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.
Other Names:
  • disc
  • artificial disc
  • cervical disc
ATLANTIS Cervical Plate System 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.
Other Names:
  • plate
  • cervical plate
  • fusion
  • cervical fusion

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637156

  Show 29 Study Locations
Sponsors and Collaborators
Medtronic Spinal and Biologics
Investigators
Principal Investigator: John K Burkus, M.D. The Hughston Clinic, P.C.
  More Information

No publications provided

Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT00637156     History of Changes
Other Study ID Numbers: PRESTIGE LP Two Level Study
Study First Received: March 3, 2008
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Spinal and Biologics:
Symptomatic DDD at Two Adjacent Levels of cervical spine

Additional relevant MeSH terms:
Radiculopathy
Intervertebral Disc Degeneration
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 16, 2014