gms | German Medical Science

Objective: Spondylotic cervical myelopathy (SCM) is a degenerative disease of the cervical spine and the leading cause of myelopathy in pts. over the age of 50. Despite significant advances in the understanding of this disease, SCM remains a clinical diagnosis and its natural history remains unclear. Therefore, the treatment of SCM is still controversial, especially in patients with mild or moderate clinical disease without rapid progression of symptoms. Aim of the planned trial is to assess whether decompressive surgery is superior to conservative treatment in mild to moderate SCM.

Methods: The TIME study (Treatment of cervIcal MyElopathy) is meant to be a prospective randomized controlled multicenter study. The primary study endpoint is the difference in overall success rate defined as maintenance or improvement of neurological status, measured by the modified Japanese Orthopaedic Association (mJOA) between treatment groups at 2 years post recruitment, as well as no additional treatment. Other outcome evaluation scores, radiological and electrophysiological follow-ups will also be analysed for thorough comparison of treatments. The study duration includes 18 months of recruitment followed by 2 years follow-up. 240 patients will be allocated to the trial and 200 patients are needed for significant differences to be observed. The primary analysis will be conducted following the intention-to-treat (ITT) principle.

Results: The TIME study protocol has been finalized and as a next step potentially participating centers will be contacted. FPFV is planned for 06/2012, LPLV 06/2015.

Conclusions: SCM treatment is a daily challenge and strong evidence is lacking. In order to achieve high-level evidence for the optimal treatment of mild to moderate cervical myelopathy we invite all interested institutions to participate in TIME.