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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)

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

Primary Outcome Measures:
  • 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.


Enrollment: 279
Study Start Date: August 2003
Estimated Study Completion Date: March 2015
Estimated 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
Other Name: ProDisc-C
Control
Anterior Cervical Discectomy and Fusion
Device: ACDF

  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; 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.
  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

No publications provided by Synthes USA HQ, Inc.

Additional 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
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration

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
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 19, 2014