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SECURE®-C Cervical Artificial Disc Clinical Study
This study is ongoing, but not recruiting participants.
First Received: April 14, 2009   Last Updated: April 15, 2009   History of Changes
Sponsored by: Globus Medical Inc
Information provided by: Globus Medical Inc
ClinicalTrials.gov Identifier: NCT00882661
  Purpose

The purpose of the study is to evaluate the safety and effectiveness of the SECURE®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease at one level between C3 and C7, compared to anterior cervical discectomy and fusion.


Condition Intervention Phase
Symptomatic Cervical Disc Disease
Device: SECURE-C Cervical Artificial Disc
Procedure: Anterior Cervical Discectomy and Fusion (ACDF)
Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Prospective Randomized Clinical Investigation of the SECURE-C Cervical Artificial Disc: A Pivotal Study

Further study details as provided by Globus Medical Inc:

Primary Outcome Measures:
  • Improvement in pain/disability using the Neck Disability Index (NDI)

Secondary Outcome Measures:
  • Improvement in neck and arm pain measured using the Visual Analog Scale (VAS), neurologic status, and health status

Enrollment: 380
Study Start Date: July 2005
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Ages Eligible for Study: 18 to 60 years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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, or functional or neurological deficit and radiographic confirmation (by CT, MRI, X-ray, etc.) of any of the following:
  • Herniated nucleus pulposus;
  • Radiculopathy or myelopathy;
  • Spondylosis (defined by the presence of osteophytes); or
  • Loss of disc height.
  • Age between 18 and 60 years
  • Failed at least 6 weeks of conservative treatment
  • Neck Disability Index (NDI) Questionnaire score of at least 30 (as percentage of 50 point total)
  • Able to understand and sign informed consent form
  • Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and filling out forms
  • Able to meet the proposed follow-up schedule at 6 weeks, 3 months, 6 months, 12 months and 24 months
  • Able to follow postoperative management program

Exclusion Criteria:

  • More than one vertebral level requiring treatment
  • Prior fusion surgery adjacent to the vertebral level being treated
  • Prior surgery at the level to be treated
  • Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
  • Radiographic confirmation of facet joint disease or degeneration, defined as apparent sclerosis and/or hypertrophy of the facets demonstrated on AP radiographs as a disruption of the normally smooth facet curve
  • Marked cervical instability on resting lateral or flexion/extension radiographs:
  • Translation greater than 3mm, and/or
  • More than 11° of rotational difference from that of either adjacent level.
  • 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, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease
  • Pregnant or interested in becoming pregnant in the next 2 years
  • Active systemic or local infection
  • Known allergy to titanium, polyethylene, cobalt, chromium or molybdenum
  • 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 has been no clinical signs or symptoms of the malignancy for at least 5 years
  • Neuromuscular disorders such as muscular dystrophy, spinal muscular atrophy, amyotrophic lateral sclerosis, etc.
  • Acute mental illness or substance abuse
  • Use of bone growth stimulator within past 30 days
  • Participation in other investigational device or drug clinical trials within 30 days of surgery
  • Prisoners
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Globus Medical Inc ( Kelly Baker, PhD, Director, Regulatory and Clinical Affairs )
Study ID Numbers: GPR002
Study First Received: April 14, 2009
Last Updated: April 15, 2009
ClinicalTrials.gov Identifier: NCT00882661     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Globus Medical Inc:
Neck Pain
Arm Pain

Study placed in the following topic categories:
Neck Pain
Pain

ClinicalTrials.gov processed this record on May 06, 2009