eprintid: 19404
rev_number: 16
eprint_status: archive
userid: 1589
dir: disk0/00/01/94/04
datestamp: 2015-12-15 10:30:33
lastmod: 2024-03-10 12:32:40
status_changed: 2015-12-15 10:30:33
type: article
metadata_visibility: show
creators_name: Tschugg, Anja
creators_name: Neururer, Sabrina
creators_name: Scheufler, Kai Michael
creators_name: Ulmer, Hanno
creators_name: Thomé, Claudius
creators_name: Hegewald, Aldemar Andres
title: Comparison of posterior foraminotomy and anterior foraminotomy with fusion for treating spondylotic foraminal stenosis of the cervical spine: study protocol for a randomized controlled trial (ForaC)
subjects: ddc-610
divisions: i-61230
abstract: Background: Cervical radiculopathy caused by spondylotic foraminal stenosis may require surgical treatment. Surgical options include anterior cervical foraminotomy and fusion or posterior cervical foraminotomy. Controversy remains regarding the preferable surgical approach. Pertinent clinical evidence is limited to low-quality observational reports. Therefore, treatment decisions are predominantly based on the individual surgeon’s preference and skill. The study objective is to evaluate the efficacy and safety of posterior foraminotomy in comparison to anterior foraminotomy with fusion for the treatment of spondylotic foraminal stenosis.   Methods/design: This is a multicenter randomized, controlled, parallel group superiority trial. A total of 88 adult patients are allocated in a ratio of 1:1. Sample size and power calculations were performed to detect the minimal clinically important difference of 14 points, with an expected standard deviation of 20 in the primary outcome parameter, Neck Disability Index, with a power of 80%, based on an assumed maximal dropout rate of 20%. Secondary outcome parameters include the Core Outcome Measures Index, which investigates pain, back-specific function, work disability, social disability and patient satisfaction. Changes in physical and mental health are evaluated using the Short Form-12 (SF-12) questionnaire. Moreover, radiological and health economic outcomes are evaluated. Follow-up is performed 3, 6, 12, 24, 36, 48 and 60 months after surgery. Major inclusion criteria are cervical spondylotic foraminal stenosis causing radiculopathy of C5, C6 or C7 and requiring decompression of one or two neuroforaminae. Study data generation (study sites) and data storage, processing and statistical analysis (Department of Medical Statistics, Informatics and Health Economics) are clearly separated. Data will be analyzed according to the intention-to-treat principle.   Discussion: The results of the ForaC study will provide surgical treatment recommendations for spondylotic foraminal stenosis and will contribute to the understanding of its short- and long-term clinical and radiological postoperative course. This will hopefully translate into improvements in surgical treatment and thus, clinical practice for spondylotic foraminal stenosis.   Trial registration Current Controlled Trials: ISRCTN82578069
date: 2014
publisher: BioMed Central
id_scheme: DOI
ppn_swb: 1654891460
own_urn: urn:nbn:de:bsz:16-heidok-194045
language: eng
bibsort: TSCHUGGANJCOMPARISON2014
full_text_status: public
publication: Trials
volume: 15
number: 437
place_of_pub: London
pagerange: 1-9
issn: 1468-6694 
citation:   Tschugg, Anja ; Neururer, Sabrina ; Scheufler, Kai Michael ; Ulmer, Hanno ; Thomé, Claudius ; Hegewald, Aldemar Andres  (2014) Comparison of posterior foraminotomy and anterior foraminotomy with fusion for treating spondylotic foraminal stenosis of the cervical spine: study protocol for a randomized controlled trial (ForaC).  Trials, 15 (437).  pp. 1-9.  ISSN 1468-6694      
document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/19404/1/13063_2013_Article_2362.pdf