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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).

Tschugg A, Neururer S, Scheufler KM, Ulmer H, Thomé C, Hegewald AA - Trials (2014)

Bottom Line: Moreover, radiological and health economic outcomes are evaluated.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Neurosurgery, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany. aldemar.hegewald@medma.uni-heidelberg.de.

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.

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Related in: MedlinePlus

Data management and randomization process. Study data generation at the study sites is clearly separated from data storage, processing and statistical analysis.
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Related In: Results  -  Collection

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Fig1: Data management and randomization process. Study data generation at the study sites is clearly separated from data storage, processing and statistical analysis.

Mentions: The allocation ratio is 1:1. The randomization code will be generated independently from the clinical investigators according to a random permuted blocks method with varying block size. Randomization will be stratified according to study centres. Statistical Software Stata 10.0 module Ralloc version 3.5.2 (Statacorp College Station, TX, USA) will be used to generate the random code. An independent statistician at the Department of Medical Statistics, Informatics and Health Economics, Innsbruck Medical University will administer the randomization code (Figure 1).Figure 1


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).

Tschugg A, Neururer S, Scheufler KM, Ulmer H, Thomé C, Hegewald AA - Trials (2014)

Data management and randomization process. Study data generation at the study sites is clearly separated from data storage, processing and statistical analysis.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4289374&req=5

Fig1: Data management and randomization process. Study data generation at the study sites is clearly separated from data storage, processing and statistical analysis.
Mentions: The allocation ratio is 1:1. The randomization code will be generated independently from the clinical investigators according to a random permuted blocks method with varying block size. Randomization will be stratified according to study centres. Statistical Software Stata 10.0 module Ralloc version 3.5.2 (Statacorp College Station, TX, USA) will be used to generate the random code. An independent statistician at the Department of Medical Statistics, Informatics and Health Economics, Innsbruck Medical University will administer the randomization code (Figure 1).Figure 1

Bottom Line: Moreover, radiological and health economic outcomes are evaluated.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Neurosurgery, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany. aldemar.hegewald@medma.uni-heidelberg.de.

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.

Show MeSH
Related in: MedlinePlus