PRODISC-C
"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)."
The trade name of the study device is PRODISC-C®.
Objective
The objective of this clinical investigation is to compare the safety and effectiveness of PRODISC-C® to ACDF surgery in the treatment of SCDD.
General Overview of the Study Design
This is a multicenter, prospective, randomized, controlled clinical trial evaluating the safety and effectiveness of PRODISC-C® total disc replacement with ACDF surgery in the treatment of SCDD. Up to ten (10) centers will participate in this study.
The patients-assignment (randomization) will be performed using a 1 to 1 ratio of PRODISC-C® recipients to control ACDF receipients.
Patients will be assigned a treatment, either a PRODISC-C® or ACDF surgery, according to a blocked randomized schedule. The block randomization will be stratified by the center.
Study Sponsor
Spine Solutions, Inc.
Status
Recruiting.
Inclusion Criteria
Patients must have the following conditions and meet the following criteria to be enrolled in this study.
1) 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 (CT, MRI or X-rays).
• Herniated nucleus pulposus;
• Spondylosis (defined by the presence of osteophytes); and/or
• Loss of disc height
2) Age between 18 and 60 years.
3) 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.
4) Neck Disability Index (NDI) score greater than or equal to 15/50 (30%) (Considered moderate disability).
5) Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
6) Signed informed consent.
Exclusion Criteria
Patients who have any of the following conditions or meet any of the following criteria are excluded from participating in this study:
1) More than one vertebral level requiring treatment.
2) 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.
3) Has a fused level adjacent to the level to be treated.
4) Radiographic confirmation of severe facet joint disease or degeneration.
5) Known allergy to cobalt, chromium, molybdenum, titanium or polyethylene.
6) 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.
7) Prior surgery at the level to be treated.
8) Severe spondylosis at the level to be treated as characterized by any of the following:
a. Bridging osteophytes;
b. A loss of disc height greater than 50%; or
c. Absence of motion (<2°)
9) Neck or arm pain of unknown etiology.
10) 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 ≤ -2.5 (The World Health Organization definition of osteoporosis).
11) Paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above).
12) Severe diabetes mellitus requiring daily insulin management.
13) Pregnant or interested in becoming pregnant in the next 3 years.
14) Active infection - systemic or local.
15) Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
16) Rheumatoid arthritis or other autoimmune disease.
17) Systemic disease including AIDS, HIV, hepatitis.
18) 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.
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