Design of the PROCON trial: a prospective, randomized multi-center study comparing cervical anterior discectomy without fusion, with fusion or with arthroplasty.
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
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.


CONCLUSIONS
The results of this study will contribute to the discussion whether additional fusion or arthroplasty is needed and cost effective.
Bartels
Ronald H M A
RH
Department of Neurosurgery, Radboud University Nijmegen Medical Centre, NL 6500 HB Nijmegen, The Netherlands. r.bartels@nch.umcn.nl
Donk
Roland
R
van der Wilt
Gert Jan
GJ
Grotenhuis
J André
JA
Venderink
Dick
D
D000293:Adolescent; D000328:Adult; D001178:Arthroplasty / Q000009:adverse effects / Q000379:methods* / Q000592:standards; D002574:Cervical Vertebrae / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D002985:Clinical Protocols; D004185:Disability Evaluation; D017586:Diskectomy / Q000009:adverse effects / Q000379:methods* / Q000592:standards; D005260:Female; D006801:Humans; D016268:Internal Fixators / Q000009:adverse effects / Q000592:standards; D007403:Intervertebral Disc / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D007405:Intervertebral Disc Displacement / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D019547:Neck Pain / Q000209:etiology / Q000517:prevention & control / Q000601:surgery; D010147:Pain Measurement; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D011446:Prospective Studies; D011788:Quality of Life; D011843:Radiculopathy / Q000209:etiology / Q000503:physiopathology / Q000601:surgery; D012107:Research Design; D013123:Spinal Fusion / Q000009:adverse effects / Q000379:methods* / Q000592:standards; D016896:Treatment Outcome; D021801:Zygapophyseal Joint / Q000473:pathology / Q000503:physiopathology / Q000601:surgery