Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT00667459
First received: April 24, 2008
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Cervical Degenerative Disc Disease
Device: PRESTIGE® LP Cervical Disc
Device: ATLANTIS Anterior Cervical Plate
Phase 3

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

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 score improvement of at least a 15-points from preoperative;
    2. Maintenance or improvement in neurological status;
    3. Disc height success;
    4. No serious adverse event classified as implant associated or implant/surgical procedure associated; and
    5. No secondary 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

  • Overall Neurological Status [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Neurological status is based on three types of measurements (sections): motor, sensory, and reflexes. Each of the sections is comprised of a number of elements. Overall neurological success will be defined as maintenance or improvement in all sections (motor, sensory, and reflex) for the time period evaluated.

  • 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

  • General Health Status [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) will be 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


  • 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

  • Gait Assessment [ 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.

  • Additional Surgical Procedures/Interventions [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 280
Study Start Date: January 2005
Estimated Study Completion Date: November 2014
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational
PRESTIGE® LP Cervical Disc
Device: PRESTIGE® LP Cervical Disc
The PRESTIGE® LP Cervical Disc is inserted into the intervertebral disc space of the cervical spine using the anterior surgical approach.
Other Name: PRESTIGE® LP
Active Comparator: Control
The study uses a group of patients who received a ACDF fusion treatment in a previous IDE trial (G010188)
Device: ATLANTIS Anterior Cervical Plate
Anterior cervical discectomy and fusion with ATLANTIS plate from control group from IDE study G010188.
Other Name: ATLANTIS plate

Detailed Description:

This pivotal clinical trial is being 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 device will be 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 (IDE # G010188)will be compared as both treatment groups receive single-level surgical treatment from C3-C4 to C6-C7 for symptomatic cervical degenerative disc disease.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00667459

  Show 20 Study Locations
Sponsors and Collaborators
Medtronic Spinal and Biologics
  More Information

No publications provided

Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT00667459     History of Changes
Other Study ID Numbers: PRESTIGE® LP Protocol, #P03-03
Study First Received: April 24, 2008
Last Updated: February 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Spinal and Biologics:
Cervical Disc

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 26, 2014