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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: September 18, 2014
Last verified: September 2014
  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

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 ] [ Designated as safety issue: Yes ]

    Rate of overall success is reported as the percentage of participants who met all of the following criteria:

    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 which was defined as either the anterior or posterior measurements meeting the criteria of "Postoperative Height - 6 Week Postoperative Height ≥ -2mm";
    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:
  • Success Rate of Neck Disability Index [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.

  • Success Rate of Neurological Status [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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 remain the same or improve from the time of the preoperative evaluation to the time period evaluated.

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

  • Neck Pain Success Rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying 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: Preoperative Score - Postoperative Score > 0.

  • Arm Pain Success Rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying 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: Preoperative Score - Postoperative Score > 0.

  • Success Rate of SF-36 PCS [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  • Gait Success Rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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, approximately 1.5 hrs. ] [ Designated as safety issue: No ]
    Operative time was recorded from skin incision to wound closure.

  • Blood Loss [ Time Frame: During the time of operation, approximately 1.5 hours. ] [ Designated as safety issue: No ]
  • Hospital Stay [ Time Frame: During the time of hospital stay, average of 1 day. ] [ Designated as safety issue: No ]
  • Rate of Secondary Surgery at Index Level [ Time Frame: 24 months post-operation ] [ Designated as safety issue: Yes ]
    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 patients who had secondary surgeries at index level.

  • Change of Neck Disability Index Score From Baseline [ Time Frame: Baseline and 24 months post-operation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Numerical rating scales were used to evaluate neck pain intensity and frequency. Patients 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, patients 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 to100) was the product 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 ] [ Designated as safety issue: No ]
    Numerical rating scales were also used to evaluate arm pain intensity and frequency. Patients 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, patients 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 100) was the product 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: 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 was inserted into the intervertebral disc space of the cervical spine using the anterior surgical approach.
Other Name: PRESTIGE® LP
Active Comparator: Control
Control patients who received a ACDF fusion treatment from a previous IDE trial (NCT00642876)
Device: ATLANTIS Anterior Cervical Plate
Anterior cervical discectomy and fusion with ATLANTIS plate for control group
Other Name: ATLANTIS plate

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

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

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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
Results First Received: August 22, 2014
Last Updated: September 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Spinal and Biologics:
Cervical Disc

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

ClinicalTrials.gov processed this record on November 25, 2014