Degenerative spondylotic myelopathy (DCM: CSM and OPLL) Cervical Spine
Conditions
Interventions
Lamina retention technique in cervical laminoplasty
D001860, D053441
Lamina retention, Cervical laminoplasty
Sponsors
Toshitaka Yoshii
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with spinal cord symptoms due to DCM (cervical spondylotic myelopathy [CSM] or ossification of the posterior longitudinal ligament [OPLL]) and scheduled to undergo cervical laminoplasty 2) Patients with spinal stenosis at the C3-7 level on MRI or CT 3) Patients aged 20 to 90 years at the time of obtaining consent 4) Patients who have given written consent to participate in this clinical study
Exclusion criteria
Exclusion criteria: 1) Patients for whom cervical laminoplasty is not appropriate as a surgical procedure (e.g. patients with marked cervical kyphosis on MRI or CT, or patients with anterior spinal cord compression or cervical instability) 2) Patients with foraminal stenosis (patients requiring posterior foraminotomy) 3) Patients with spinal infection 4) Patients with spinal tumors (including metastatic tumors) 5) Patients with traumatic compressive myelopathy (including patients with central spinal cord injury) 6) Patients with a history of cervical spine surgery 7) Patients with dialysis 8) Patients with cerebral palsy 9) Patients with Parkinson's disease 10) Pregnant women or women who may be pregnant 11) Other patients who the principal investigator (or sub-investigator) deems unsuitable for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement ratio of cervical Japanese Orthopaedic Association (JOA) score between before and after surgery: The primary analysis will be conducted at 1 year after surgery. The results at 2 years after surgery will also be shown as a final analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Operating time 2) Estimated blood loss 3) Achievement rate of the minimum clinically important difference (MCID) in the improvement ratio of the cervical JOA score at 1 and 2 years after surgery 4) Health-related quality of life (EQ-5D) at 1 and 2 years after surgery 5) Degree of neck pain, upper limb pain, and upper limb numbness (visual analogue scales: VAS) at 1 and 2 years after surgery 6) Neck disability index (NDI) before and after surgery at 1 and 2 years post-operatively 7) Retention rate of expanded laminoplasty at 1 and 2 years post-operatively 8) Percentage of hinge fractures at 1 and 2 years post-operatively 9) Percentage of bone fusion at 1 and 2 years post-operatively 10) Cervical spine alignment (C-SVA, C2-7 angle, T1 slope) at 1 and 2 years post-operatively 11) Cross-sectional area of paravertebral muscles (C4/5 level) at 1 and 2 years post-operatively 12) Dural tube area at 1 and 2 years after surgery (C3/4, C4/5, C5/6, C6/7 levels) 13) Grading of the mass posterior to the dural sac at 1 and 2 years after surgery 14) Incremental cost-effectiveness ratio (ICER) 15) Rate of surgical complications | — |
Contacts
Public ContactYamada Kentaro
Institute of Science Tokyo
Outcome results
None listed