Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Synthes USA HQ, Inc.
First received: February 10, 2006
Last updated: May 28, 2013
Last verified: May 2013
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).
Symptomatic Cervical Disc Disease
Device: Total Disc Replacement
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)
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.
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2015 (Final data collection date for primary outcome measure)
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
Anterior Cervical Discectomy and Fusion
|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 by Synthes USA HQ, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Synthes USA HQ, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 10, 2006
||May 28, 2013
||United States: Food and Drug Administration
Keywords provided by Synthes USA HQ, Inc.:
Anterior cervical diskectomy
Degenerative disc disease
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 04, 2013