Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD
This study is ongoing, but not recruiting participants.
Information provided by:
Synthes USA HQ, Inc.
First received: February 10, 2006
Last updated: July 1, 2011
Last verified: July 2011
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).
Prostheses and Implants
Device: Total Disc Replacement
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
||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)
| Estimated Enrollment:
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
No Contacts or Locations Provided
No publications provided
||Damon Lees, Clinical Regulatory Manager, Spine Global Regulatory & Clinical Affairs, Synthes USA HQ. Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 10, 2006
||July 1, 2011
||United States: Food and Drug Administration
Keywords provided by Synthes USA HQ, Inc.:
ClinicalTrials.gov processed this record on May 19, 2013
Anterior cervical diskectomy
Degenerative disc disease