• Ronald H M A Bartels, Roland Donk, Gert Jan van der Wilt, J André Grotenhuis, and Dick Venderink.
• Department of Neurosurgery, Radboud University Nijmegen Medical Centre, NL 6500 HB Nijmegen, The Netherlands. r.bartels@nch.umcn.nl
• Bmc Musculoskel Dis. 2006 Jan 1;7:85.

BackgroundPROCON was designed to assess the clinical outcome, development of adjacent disc disease and costs of cervical anterior discectomy without fusion, with fusion using a stand alone cage and implantation of a Bryan's disc prosthesis. Description of rationale and design of PROCON trial and discussion of its strengths and limitations.Methods/DesignSince proof justifying the use of implants or arthroplasty after cervical anterior discectomy is lacking, PROCON was designed. PROCON is a multicenter, randomized controlled trial comparing cervical anterior discectomy without fusion, with fusion with a stand alone cage or with implantation of a disc. The study population will be enrolled from patients with a single level cervical disc disease without myelopathic signs. Each treatment arm will need 90 patients. The patients will be followed for a minimum of five years, with visits scheduled at 6 weeks, 3 months, 12 months, and then yearly. At one year postoperatively, clinical outcome and self reported outcomes will be evaluated. At five years, the development of adjacent disc disease will be investigated.DiscussionThe results of this study will contribute to the discussion whether additional fusion or arthroplasty is needed and cost effective.

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