Design of the PROCON trial: Comparing cervical discectomy methods
Author Information
Author(s): Bartels Ronald HMA, Donk Roland, van der Wilt Gert Jan, Grotenhuis J André, Venderink Dick
Primary Institution: Radboud University Nijmegen Medical Centre
Hypothesis
Is there a difference in clinical outcomes and cost-effectiveness between cervical anterior discectomy without fusion, with fusion, and with arthroplasty?
Conclusion
The study aims to determine the best surgical option for cervical disc disease and assess the associated costs.
Supporting Evidence
- The study will follow patients for a minimum of five years to assess outcomes.
- Each treatment arm will require 90 patients for adequate power.
- Cost-effectiveness will be analyzed based on resource requirements and productivity loss.
Takeaway
Doctors are trying to find out which surgery is best for neck problems by comparing three different methods over five years.
Methodology
A multicenter, randomized controlled trial with three treatment arms and a follow-up period of five years.
Potential Biases
Randomization may not be easily accepted by patients, which could introduce bias.
Limitations
The study's external validity may be limited due to strict inclusion criteria and potential patient reluctance to participate.
Participant Demographics
Adult patients aged 18 to 55 with specific cervical disc disease symptoms.
Statistical Information
P-Value
p<0.05
Digital Object Identifier (DOI)
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