ACTRN12611000646943
Recruiting
Phase 4
A multi-center, prospective, randomised controlled trial comparing the efficacy and safety of PRODISC-C (Registered Trade Mark) implant to anterior cervical discectomy and fusion (ACDF) surgery, in the treatment of symptomatic cervical disc disease (SCDD)
Synthes Asia Pacific0 sites300 target enrollmentJune 23, 2011
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Symptomatic cervical disc disease (SCDD)
- Sponsor
- Synthes Asia Pacific
- Enrollment
- 300
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subjects with symptomatic cervical disc disease (SCDD) in only 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 (Computed Tomography scans, Magnetic Resonance Imagings or X\-rays)
- •\-Herniated nucleus pulposus
- •\-Spondylosis (defined by the presence of osteophytes)
- •\-Loss of disc height
- •2\.Unresponsive to non\-operative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root compression in the face of conservative treatment.
- •3\.Neck Disability Index (NDI) score greater than or equal to 15/50 (30%) (Considered moderate disability).
Exclusion Criteria
- •1\.More than one vertebral level requiring treatment (showing marked changes at a second level)
- •Marked cervical instability on resting lateral or flexion/extension radiographs:
- •a.translation greater than 3 mm and/or
- •b.greater than 11 degrees of rotational difference to that of either adjacent level .
- •2\.Radiographic confirmation of severe facet joint disease or degeneration.
- •3\.Known allergy to cobalt, chromium, molybdenum, titanium or polyethylene.
- •Clinically compromised 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.
- •4\.Severe spondylosis at the level to be treated as characterized by any of the following:
- •\- Bridging osteophytes;
- •\- A loss of disc height greater than 70%
Outcomes
Primary Outcomes
Not specified
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