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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2010

Open Access 01-12-2010 | Study protocol

The Felix-trial. Double-blind randomization of interspinous implant or bony decompression for treatment of spinal stenosis related intermittent neurogenic claudication

Authors: Wouter A Moojen, Mark P Arts, Ronald Brand, Bart W Koes, Wilco C Peul

Published in: BMC Musculoskeletal Disorders | Issue 1/2010

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Abstract

Background

Decompressive laminotomy is the standard surgical procedure in the treatment of patients with canal stenosis related intermittent neurogenic claudication. New techniques, such as interspinous process implants, claim a shorter hospital stay, less post-operative pain and equal long-term functional outcome. A comparative (cost-) effectiveness study has not been performed yet. This protocol describes the design of a randomized controlled trial (RCT) on (cost-) effectiveness of the use of interspinous process implants versus conventional decompression surgery in patients with lumbar spinal stenosis.

Methods/Design

Patients (age 40-85) presenting with intermittent neurogenic claudication due to lumbar spinal stenosis lasting more than 3 months refractory to conservative treatment, are included. Randomization into interspinous implant surgery versus bony decompression surgery will take place in the operating room after induction of anesthesia. The primary outcome measure is the functional assessment of the patient measured by the Zurich Claudication Questionnaire (ZCQ), at 8 weeks and 1 year after surgery. Other outcome parameters include perceived recovery, leg and back pain, incidence of re-operations, complications, quality of life, medical consumption, absenteeism and costs. The study is a randomized multi-institutional trial, in which two surgical techniques are compared in a parallel group design. Patients and research nurses are kept blinded of the allocated treatment during the follow-up period of 1 year.

Discussion

Currently decompressive laminotomy is the golden standard in the surgical treatment of lumbar spinal stenosis. Whether surgery with interspinous implants is a reasonable alternative can be determined by this trial.

Trial register

Dutch Trial register number: NTR1307
Appendix
Available only for authorised users
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Metadata
Title
The Felix-trial. Double-blind randomization of interspinous implant or bony decompression for treatment of spinal stenosis related intermittent neurogenic claudication
Authors
Wouter A Moojen
Mark P Arts
Ronald Brand
Bart W Koes
Wilco C Peul
Publication date
01-12-2010
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2010
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/1471-2474-11-100

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