Design of Lamifuse: a randomised, multi-centre controlled trial comparing laminectomy without or with dorsal fusion for cervical myeloradiculopathy.
BACKGROUND
laminectomy is a valuable surgical treatment for some patients with a cervical radiculomyelopathy due to cervical spinal stenosis. More recently attention has been given to motion of the spinal cord over spondylotic spurs as a cause of myelopathic changes. Immobilisation by fusion could have a positive effect on the recovery of myelopathic signs or changes. This has never been investigated in a prospective, randomised trial. Lamifuse is an acronyme for laminectomy and fusion.


METHODS
Lamifuse is a multicentre, randomised controlled trial comparing laminectomy with and without fusion in patients with a symptomatic cervical canal stenosis. The study population will be enrolled from patients that are 60 years or older with myelopathic signs and/or symptoms due to a cervical canal stenosis. A kyphotis shape of the cervical spine is an exclusion criterium. Each treatment arm needs 30 patients.


CONCLUSIONS
This study will contribute to the discussion whether additional fusion after a cervical laminectomy results in a better clinical outcome. ISRCT NUMBER: ISRCTN72800446.
Bartels
Ronald Hma
RH
Department of Neurosurgery, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. r.bartels@nch.umcn.nl
Verbeek
André L M
AL
Grotenhuis
J André
JA
D000368:Aged; D002574:Cervical Vertebrae / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D002985:Clinical Protocols; D019299:Decompression, Surgical / Q000295:instrumentation / Q000379:methods; D005260:Female; D006801:Humans; D016268:Internal Fixators / Q000592:standards; D007405:Intervertebral Disc Displacement / Q000473:pathology / Q000503:physiopathology / Q000601:surgery; D007796:Laminectomy / Q000295:instrumentation / Q000592:standards*; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D017063:Outcome Assessment, Health Care / Q000379:methods; D011843:Radiculopathy / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D011859:Radiography; D013117:Spinal Cord Compression / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D013123:Spinal Fusion / Q000295:instrumentation / Q000592:standards*; D013128:Spinal Osteophytosis / Q000473:pathology / Q000503:physiopathology / Q000601:surgery