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Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier:
NCT00291018
First received: February 10, 2006
Last updated: January 17, 2017
Last verified: January 2017
  Purpose
The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc-C to anterior cervical discectomy and fusion (ACDF) surgery in the treatment of symptomatic cervical disc disease (SCDD).

Condition Intervention
Symptomatic Cervical Disc Disease Device: Total Disc Replacement Device: ACDF

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of ProDisc-C to Anterior Cervical Discectomy and Fusion (ACDF) Surgery in the Treatment of Symptomatic Cervical Disc Disease (SCDD)

Resource links provided by NLM:


Further study details as provided by Synthes USA HQ, Inc.:

Primary Outcome Measures:
  • Overall Success [ Time Frame: 84 Months ]

    Sponsor Definition of Overall Success:

    1. Subject's NDI score improved by at least 20% over preoperative baseline value
    2. Subject's neurologic parameters, i.e. motor, sensory, and reflexes were maintained or improved as compared to preoperative baseline value
    3. No removals, revisions, re-operations, or additional fixation were required to modify any implant
    4. No adverse events occurred which were related to the treatment, ProDisc-C or its implantation or ACDF surgery or its associated implants or graft material


Secondary Outcome Measures:
  • Neurologic Success [ Time Frame: 84 months ]
    % of subjects who were a neurological success (i.e. the patient's neurologic parameters, i.e. motor, sensory, and reflexes are maintained or improved as compared to preoperative baseline value)

  • NDI [ Time Frame: 84 months ]

    The NDI is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation and is the most commonly used self-report measure for neck pain.

    The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0-5 rating scale (0 = 'No pain' and 5 = 'Worst imaginable pain'). The points can be summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage: 0 points or 0% means : no activity limitations, 50 points or 100% means complete activity limitation.

    Mean duration of the test is 3-8 minutes and the results can be interpreted as (see below):

    • 0-4 points (0-8%) no disability,
    • 5-14 points (10-28%) mild disability,
    • 15-24 points (30-48% ) moderate disability,
    • 25-34 points (50- 64%) severe disability,
    • 35-50 points (70-100%) complete disability.

  • SF-36 Physical Composite Score (PCS) [ Time Frame: 84 Months ]

    The Short Form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment.

    It can take patients at least half an hour to complete the SF-36.

    The Physical Composite Score (PCS) specifically looks at the mean average of all of the physically relevant questions.


  • SF-36 Mental Composite Score (MCS) [ Time Frame: 84 Months ]

    The Short Form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment.

    It can take patients at least half an hour to complete the SF-36.

    The Mental Composite Score (MCS) specifically looks at the mean average of all of the mental or emotional relevant questions.


  • Visual Analog Scale (VAS) Satisfaction [ Time Frame: 84 Months ]
    The visual analogue scale (VAS) is commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No Satisfaction [with the surgery/outcome]" at 0mm and "Completely Satisfied [with the surgery/outcome]" at 100mm.

  • Visual Analog Scale (VAS) Neck Pain Intensity [ Time Frame: 84 Months ]
    The visual analogue scale (VAS) is commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No [Neck] Pain" at 0mm and "Worst [Neck] Pain Possible" at 100mm.

  • Visual Analog Scale (VAS) Neck Pain Frequency [ Time Frame: 84 Months ]
    The visual analogue scale (VAS) is commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "None of the Time [Neck] Pain" at 0mm and "All of the Time [Neck] Pain" at 100mm.

  • Visual Analog Scale (VAS) Arm Pain Intensity [ Time Frame: 84 Months ]
    The visual analogue scale (VAS) is commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No [Arm] Pain" at 0mm and "Worst [Arm] Pain Possible" at 100mm.

  • Visual Analog Scale (VAS) Arm Pain Frequency [ Time Frame: 84 Months ]
    The visual analogue scale (VAS) is commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "None of the Time [Arm] Pain" at 0mm and "All of the Time [Arm] Pain" at 100mm.

  • Surgery Again [ Time Frame: 84 Months ]
    % of subjects who would opt to have the surgery again if given the choice at 84 months.


Enrollment: 368
Study Start Date: August 2003
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ProDisc-C
ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Device: Total Disc Replacement
Total Disc Replacement using ProDisc-C
Other Name: ProDisc-C
Active Comparator: Control
ACDF
Device: ACDF
Anterior Cervical Discectomy and Fusion
Other Name: Control

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic cervical disc disease (SCDD) in one vertebral level between C3-C7 defined as: Neck or arm (radicular) pain; and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI or X-rays): Herniated nucleus pulposus; Spondylosis (defined by the presence of osteophytes); and/or Loss of disc height.
  • Age between 18 and 60 years.
  • Unresponsive to non-operative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment.
  • NDI score greater than or equal to 15/50 (30%).
  • Psychosocially, mentally and physically able to fully comply with the protocol including adhering to follow-up schedule and requirements and filling out forms.
  • Signed informed consent.

Exclusion Criteria:

  • More than one vertebral level requiring treatment.
  • Marked cervical instability on resting lateral or flexion/extension radiographs: translation greater than 3mm and/or greater than 11 degrees of rotational difference to that of either adjacent level.
  • Has a fused level adjacent to the level to be treated.
  • Radiographic confirmation of severe facet joint disease or degeneration.
  • Known allergy to cobalt, chromium, molybdenum, titanium or polyethylene.
  • Clinically comprised vertebral bodies at the affected level(s) due to current or past trauma, e.g. by the radiographic appearance of fracture callus, malunion or nonunion.
  • Prior surgery at the level to be treated.
  • Severe spondylosis at the level to be treated as characterized by any of the following: Bridging osteophytes; A loss of disc height greater than 50%; or Absence of motion (<2°).
  • Neck or arm pain of unknown etiology.
  • Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA (dual energy x-ray absoptiometry) bone mineral density measurement. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score less than or equal to -2.5 (the World Health Organization definition of osteoporosis).
  • Paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above).
  • Severe diabetes mellitus requiring daily insulin management.
  • Pregnant or interested in becoming pregnant in the next three years.
  • Active infection - systemic or local.
  • Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
  • Rheumatoid arthritis or other autoimmune disease.
  • Systemic disease including AIDS, HIV, hepatitis.
  • Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
  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.

No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier: NCT00291018     History of Changes
Other Study ID Numbers: PDC-08122003
Study First Received: February 10, 2006
Results First Received: November 17, 2016
Last Updated: January 17, 2017

Keywords provided by Synthes USA HQ, Inc.:
ProDisc
ProDisc-C
Spinal Fusion
Anterior cervical diskectomy
Cervical spine
Disc disease
Implant
Degenerative disc disease
Intervertebral disc

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Displacement
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 23, 2017