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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:
ClinicalTrials.gov Identifier:
NCT00637156
First Posted: March 17, 2008
Last Update Posted: December 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
  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
Cervical Degenerative Disc Disease Radiculopathy Myelopathy Device: PRESTIGE LP device at two adjacent levels Device: Bi-level fusion with ATLANTIS Cervical Plate System

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:
  • Rate of Overall Success [ Time Frame: 24 Months ]

    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."


Secondary Outcome Measures:
  • Success Rate of Neck Disability Index [ Time Frame: 24 months ]
    Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15.

  • Success Rate of Neurological Status [ Time Frame: 24 months ]
    Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must either remain the same or improve from the time of the preoperative evaluation to the time period evaluated.

  • Neck Pain Success Rate [ Time Frame: 24 months ]
    Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was 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 frequency 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"). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0.

  • Arm Pain Success Rate [ Time Frame: 24 months ]
    Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was 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 frequency 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"). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0.

  • Success Rate of SF-36 PCS [ Time Frame: 24 months ]
    Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.

  • Success Rate of SF-36 MCS [ Time Frame: 24 months ]
    Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.

  • Rate of Disc Height Success [ Time Frame: 24 months ]
    Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height >= -2mm

  • Gait Success Rate [ Time Frame: 24 months ]
    Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0. The gait success rate is reported as the percentage of participants who had gait success.

  • Operative Time [ Time Frame: Time of operation, an average of 1.7-2.1hrs ]
    Operative time was recorded from skin incision to wound closure.

  • Blood Loss [ Time Frame: During the time of operation, an average of 1.7-2.1 hrs ]
  • Hospital Stay [ Time Frame: From admission to discharge, an average of 1.0-1.5 day ]
  • Rate of Secondary Surgery at Index Level [ Time Frame: 24 months ]
    Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of subjects who had secondary surgeries at index level.

  • Change of Neck Disability Index Score From Baseline [ Time Frame: Baseline and 24 months post-operation ]
    The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.

  • Change of Neck Pain Score From Baseline [ Time Frame: Baseline and 24 months post-operation ]
    Numerical rating scales were used to evaluate neck pain intensity and frequency. Subjects rated their neck pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their neck pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total neck pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline.

  • Change of Arm Pain Score From Baseline [ Time Frame: Baseline and 24 months post-operation ]
    Numerical rating scales were also used to evaluate arm pain intensity and frequency. Subjects rated their arm pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their arm pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total arm pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline.

  • Change of General Health Status -- SF-36 PCS From Baseline [ Time Frame: Baseline and 24 months post-operation ]
    The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.

  • Change of General Health Status -- SF-36 MCS From Baseline [ Time Frame: Baseline and 24 months post-operation ]
    The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.


Enrollment: 397
Study Start Date: June 2006
Estimated Study Completion Date: March 2018
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT00637156     History of Changes
Other Study ID Numbers: PRESTIGE LP Two Level Study
First Submitted: March 3, 2008
First Posted: March 17, 2008
Results First Submitted: August 2, 2016
Results First Posted: November 18, 2016
Last Update Posted: December 1, 2017
Last Verified: October 2017

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

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