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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier:
NCT00291018
First received: February 10, 2006
Last updated: July 3, 2014
Last verified: July 2014

February 10, 2006
July 3, 2014
August 2003
March 2015   (final data collection date for primary outcome measure)
  • NDI [ Time Frame: 84 months ] [ Designated as safety issue: No ]
    The patient's NDI Score improves by at least 20% over preoperative baseline value
  • Neurologic Parameters [ Time Frame: 84 months ] [ Designated as safety issue: No ]
    The patient's neurologic parameters, i.e. motor, sensory, and reflexes are maintained or improved as compared to preoperative baseline value
  • Secondary Surgeries [ Time Frame: 84 months ] [ Designated as safety issue: Yes ]
    No removals, revisions, re-operations or additional fixation were required to modify any implant.
  • Adverse Events [ Time Frame: 84 months ] [ Designated as safety issue: Yes ]
    No adverse events occur which are related to the treatment, ProDisc-C or its implantation or ACDF surgery or its associated implants or graft material.
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Complete list of historical versions of study NCT00291018 on ClinicalTrials.gov Archive Site
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Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD
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).

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Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Symptomatic Cervical Disc Disease
  • Device: Total Disc Replacement
    Other Name: ProDisc-C
  • Device: ACDF
  • Experimental: ProDisc-C
    ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
    Intervention: Device: Total Disc Replacement
  • Control
    Anterior Cervical Discectomy and Fusion
    Intervention: Device: ACDF

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
279
March 2015
March 2015   (final data collection date for primary outcome measure)

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 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., steriods).
  • 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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00291018
PDC-08122003
Not Provided
Synthes USA HQ, Inc.
Synthes USA HQ, Inc.
Not Provided
Not Provided
Synthes USA HQ, Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP