A multi-center, prospective, randomised controlled trial comparing the efficacy and safety of PRODISC-C implant to anterior cervical discectomy and fusion (ACDF) surgery, in the treatment of symptomatic cervical disc disease (SCDD)
- Conditions
- Symptomatic cervical disc disease (SCDD)Musculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12611000646943
- Lead Sponsor
- Synthes Asia Pacific
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
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).
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%
- Absence of motion (<2 degrees).
5.Neck or arm pain of unknown etiology.
6.Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require
a Dual Energy X-ray Absorptiometry (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. )
7.Paget’s disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above).
8.Severe diabetes mellitus requiring insulin management
9.Pregnant
10.Active infection - systemic or local.
11.Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
12.Rheumatoid arthritis or other autoimmune disease.
13.Systemic disease including AIDS, HIV, hepatitis.
14.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.
15.Workers compensation or action compensation patients (at the surgeons discretion).
16.Subjects involved in other trials within the last month, prior to screening.
17.Subjects refused to agree to either ProDisc-C or Anterior Cervical Discectomy and Fusion (ACDF) treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method