PROCON试验设计：一项前瞻性、随机多中心研究，比较颈椎前路椎间盘切除不融合、融合或关节成形术。
Design of the PROCON trial: a prospective, randomized multi-center study comparing cervical anterior discectomy without fusion, with fusion or with arthroplasty.
作者信息
Bartels Ronald H M A, Donk Roland, van der Wilt Gert Jan, Grotenhuis J André, Venderink Dick
机构信息
Department of Neurosurgery, Radboud University Nijmegen Medical Centre, NL 6500 HB Nijmegen, The Netherlands.
出版信息
BMC Musculoskelet Disord. 2006 Nov 10;7:85. doi: 10.1186/1471-2474-7-85.
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.
背景
PROCON旨在评估颈椎前路椎间盘切除不融合术、使用单独椎间融合器融合术以及植入Bryan椎间盘假体的临床疗效、相邻椎间盘疾病的发展情况和成本。介绍PROCON试验的基本原理和设计，并讨论其优点和局限性。
方法/设计：由于缺乏颈椎前路椎间盘切除术后使用植入物或关节成形术的合理性证据，因此设计了PROCON试验。PROCON是一项多中心随机对照试验，比较颈椎前路椎间盘切除不融合术、使用单独椎间融合器融合术和植入椎间盘假体术。研究对象将从患有单节段颈椎间盘疾病且无脊髓病体征的患者中招募。每个治疗组需要90名患者。患者将至少随访五年，随访时间安排在术后6周、3个月、12个月，之后每年随访一次。术后一年，评估临床疗效和自我报告的结果。五年时，调查相邻椎间盘疾病的发展情况。
讨论
本研究结果将有助于讨论是否需要额外的融合术或关节成形术以及其成本效益。
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