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Study protocol for a randomised controlled multicentre study

the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) in patients with cervical radiculopathy.

Study protocol for a randomised controlled multicentre study

the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) in patients with cervical radiculopathy.

Samenvatting

The Foraminotomy ACDF Cost-Effectiveness Trial (FACET) study is the first randomised controlled trial investigating anterior discectomy with fusion versus foraminotomy for cervical foraminal pathology. Methodological strengths include an appropriate sample size based on a non-inferiority design, seven participating medical centres and an independent institute facilitating the randomisation system and monitoring activities. The study is performed with care as usual; therefore, the final results of this study could be generalisable to usual clinical practice. With respect to the evaluation of spinal fusion and instrumentation failure, the relatively short follow-up period of 2 years could be a limitation of this study. In this study, it is not feasible to blind the participant and the surgeon to the allocated treatment.
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Trefwoorden
OrganisatieSaxion
AfdelingAcademie AGZ
LectoraatGezondheid & Bewegen
Datum2017-01-01
TypeArtikel
TaalEngels

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