Design of Lamifuse: a randomised, multi-centre controlled trial comparing laminectomy without or with dorsal fusion for cervical myeloradiculopathy

• Main Authors: Grotenhuis J André, Verbeek André LM, Bartels Ronald HMA
• Format: Article
• Language: English
• Published: BMC 2007-11-01
• Series: BMC Musculoskeletal Disorders
• Online Access: http://www.biomedcentral.com/1471-2474/8/111

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>This study will contribute to the discussion whether additional fusion after a cervical laminectomy results in a better clinical outcome.</p> <p>ISRCT number</p> <p>ISRCTN72800446</p>