• J Neurosurg Spine · Apr 2005

    Clinical Trial

    Early results after ProDisc-C cervical disc replacement.

    • Rudolf Bertagnoli, James J Yue, Frank Pfeiffer, Andrea Fenk-Mayer, James P Lawrence, Trace Kershaw, and Regina Nanieva.
    • Department of Orthopaedic Surgery, Spine Center, St Elizabeth Klinikum, Straubing, Germany.
    • J Neurosurg Spine. 2005 Apr 1;2(4):403-10.

    ObjectCervical anterior decompression and total-disc replacement is currently being investigated as an alternative treatment in patients with symptomatic intervertebral cervical spondylosis with and without radiculopathy. The authors prospectively investigated the safety and efficacy of using the ProDisc-C disc for cervical arthroplasty in the treatment of symptomatic cervical spondylosis.MethodsSixteen patients in whom a diagnosis of symptomatic cervical spondylosis had been established were prospectively treated with complete anterior cervical discectomy and ProDisc-C cervical disc arthroplasty. Overall 12 single- and four two-level procedures were performed (20 prostheses). Patients underwent pre- and multiple postoperative assessments (3 and 6 weeks and 3, 6, and 12 months). The median age of all patients was 50 years (range 32-60 years). Levels of surgery included seven C5-6, six C6-7, and three C4-5. Neck and arm pain as well as disability scores were significantly improved by 3 months and remained significantly improved at 1 year. No additional fusion surgeries were necessary at the affected or unaffected levels. Radiography revealed an affected disc motion from 4 to 12 degrees. No surgery- or device-related complications were documented.ConclusionsAnalysis of preliminary results involving ProDisc-C arthroplasty indicates significant improvement in pain and functional outcome scores. No spontaneous fusions at the level of surgery or at adjacent levels were noted. Long-term follow-up studies will be necessary before more definitive treatment recommendations can be formulated.

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