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)

Exclusion Criteria25

• 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 .
• Radiographic confirmation of severe facet joint disease or degeneration.
• 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.
• 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).
• 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 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. )
• Paget’s disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above).
• Severe diabetes mellitus requiring insulin management
• Pregnant
• Active infection - systemic or local.
• Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
• 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.
• Workers compensation or action compensation patients (at the surgeons discretion).
• Subjects involved in other trials within the last month, prior to screening.
• Subjects refused to agree to either ProDisc-C or Anterior Cervical Discectomy and Fusion (ACDF) treatment.