TY - JOUR
T1 - The Felix-trial. Double-blind randomization of interspinous implant or bony decompression for treatment of spinal stenosis related intermittent neurogenic claudication
AU - Moojen, Wouter A.
AU - Arts, Mark P.
AU - Brand, Ronald
AU - Koes, Bart W.
AU - Peul, Wilco C.
N1 - Funding Information:
The Felix trial is funded by Paradigm Spine/InSpine and will be carried out by The Leiden - The Hague SIPS group. Furthermore we want to thank the researchnurses and datamanager of the SIPS group for their work in making this trial possible.
PY - 2010
Y1 - 2010
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=77953659389&partnerID=8YFLogxK
U2 - 10.1186/1471-2474-11-100
DO - 10.1186/1471-2474-11-100
M3 - Article
C2 - 20507568
AN - SCOPUS:77953659389
SN - 1471-2474
VL - 11
JO - BMC Musculoskeletal Disorders
JF - BMC Musculoskeletal Disorders
M1 - 100
ER -