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Symptomatic Cervical Disc DiseaseNCT00291018

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

A study testing Total Disc Replacement and ACDF in people with Symptomatic Cervical Disc Disease, run by Synthes USA HQ, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Symptomatic Cervical Disc Disease
What is being tested?
Total Disc Replacement and ACDF
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
368 participants
Where
No sites listed yet
Study dates
1 Aug 2003to 1 Mar 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

About this study

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)

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).

Being tested
Total Disc Replacement, ACDF
Keywords
ProDisc, ProDisc-C, Spinal Fusion, Anterior cervical diskectomy, Cervical spine, Disc disease, Implant, Degenerative disc disease, Intervertebral disc
Medical subject headings
Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total Disc ReplacementDevice

    Also called ProDisc-C

    Total Disc Replacement using ProDisc-C

  • ACDFDevice

    Also called Control

    Anterior Cervical Discectomy and Fusion

Study groups in NCT00291018
Study groupRoleWhat they receive
ProDisc-CExperimentalProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Receives: Device: Total Disc Replacement
ControlActive comparatorACDF
Receives: Device: ACDF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Success

    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

    Measured: 84 Months

Secondary outcomes (10)

  1. Neurologic Success

    % 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)

    Measured: 84 months

  2. NDI

    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:

    • 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

    Measured: 84 months

  3. SF-36 Physical Composite Score (PCS)

    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.

    Measured: 84 Months

  4. SF-36 Mental Composite Score (MCS)

    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.

    Measured: 84 Months

  5. VAS Satisfaction

    The Visual Analog Scale (VAS) is a 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 "Complete Satisfaction [with the surgery/outcome]" at 100mm.

    Measured: 84 Months

  6. VAS Neck Pain Intensity

    The Visual Analog Scale (VAS) is a 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.

    Measured: 84 Months

  7. VAS Neck Pain Frequency

    The Visual Analog Scale (VAS) is a 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.

    Measured: 84 Months

  8. VAS Arm Pain Intensity

    The Visual Analog Scale (VAS) is a 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.

    Measured: 84 Months

  9. VAS Arm Pain Frequency

    The Visual Analog Scale (VAS) is a 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.

    Measured: 84 Months

  10. Surgery Again

    % of subjects who would opt to have the surgery again if given the choice at 84 months

    Measured: 84 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2006 (estimated)
  2. Study start1 Aug 2003
  3. Primary completion1 Mar 2015
  4. Study completion1 Mar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
368 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00291018
Sponsor's protocol ID
PDC-08122003
Status last verified
Oct 2017
First submitted
10 Feb 2006
Last updated
20 Nov 2017
Data monitoring committee
No

Publications

  • Mancuso CA, Cammisa FP, Sama AA, Hughes AP, Girardi FP. Development of an expectations survey for patients undergoing cervical spine surgery. Spine (Phila Pa 1976). 2013 Apr 20;38(9):718-25. doi: 10.1097/BRS.0b013e31827bf204.

    PubMed 23138404

  • Zigler JE, Delamarter R, Murrey D, Spivak J, Janssen M. ProDisc-C and anterior cervical discectomy and fusion as surgical treatment for single-level cervical symptomatic degenerative disc disease: five-year results of a Food and Drug Administration study. Spine (Phila Pa 1976). 2013 Feb 1;38(3):203-9. doi: 10.1097/BRS.0b013e318278eb38.

    PubMed 23080427

Questions about this trial

What is this clinical trial studying?

A study testing Total Disc Replacement and ACDF in people with Symptomatic Cervical Disc Disease, run by Synthes USA HQ, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Success (time frame: 84 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00291018, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.

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