Background: PROCON 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/Design: Since 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. Discussion: The results of this study will contribute to the discussion whether additional fusion or arthroplasty is needed and cost effective. Trial registration: Current Controlled Trials ISRCTN41681847 © 2006 Bartels et al; licensee BioMed Central Ltd.
CITATION STYLE
Bartels, R. H. M. A., Donk, R., Van Der Wilt, G. J., Grotenhuis, J. A., & Venderink, D. (2006). Design of the PROCON trial: A prospective, randomized multi - Center study comparing cervical anterior discectomy without fusion, with fusion or with arthroplasty. BMC Musculoskeletal Disorders, 7. https://doi.org/10.1186/1471-2474-7-85
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