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: May 28, 2013
Last verified: May 2013
  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
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: May 28, 2013
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 April 23, 2014