Fusion or no Fusion After Decompression of the Spinal Cord in Patients With Degenerative Cervical Myelopathy (MyRanC)
Cervical Spondylotic Myelopathy
About this trial
This is an interventional treatment trial for Cervical Spondylotic Myelopathy focused on measuring Cervical fusion, Cervical spine, Laminectomy, Spinal surgery, Randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- Age >18 years
- 1-4 levels of cervical degenerative myelopathy in the subaxial spine, C3-C7, without or with deformity not exceeding exclusion criteria, see below.
- Eligible for both treatments
- Ability to understand and read Swedish language
- Symptomatic myelopathy with at least one clinical sign of myelopathy
- No previous spine surgery
- Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures
Personally, signed and dated informed consent document prior to any study-related procedures, indicating that the patient has been informed of all pertinent aspects of the trial
- Definition of kyphosis - cSVA > 40 mm and/or C2-C7 Cobb > 10° kyphosis. Definition of spondylolisthesis - anterior slippage of > 2 mm on cervical radiographs taken in the neutral position.
Exclusion Criteria:
- Local kyphosis; a modified K-line minimum interval distance (INT) of <4 mm
- Spondylolisthesis >4 mm and simultaneous translation >2 mm on lateral flexion/extension radiographs
- Soft disc herniations only (no signs of osteophyte formation and hypertrophy of the ligamentum flavum)
- Active infection
- Neoplasm
- Trauma
- Inflammatory disease (i.e., rheumatoid arthritis or ankylosing spondylitis or DISH)
- Systemic disease including HIV
- Lumbar or thoracic spinal disease to the extent that surgical consideration is probable or anticipated within 6 months after the cervical surgical treatment (significant lumbar stenosis as defined by Schizas C or worse).
- OPLL
- Parkinson´s disease
- Drug abuse, dementia, or other reason to suspect poor adherence to follow-up
- Previous cervical spine surgery
Sites / Locations
- Academic Hospital of UppsalaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Muscle preserving selective laminectomy (L-group)
Laminectomy with instrumented fusion (LF-group)
Muscle-preserving selective laminectomy with a posterior midline incision and dissection through the nuchal fascia. The spinous processes are split in the midline using a high-speed burr/ultrasound knife and without disturbing the deep extensor muscles on either side. Angulating away from the midline, the spinous processes are divided at their bases. Laminectomy is performed with a width no more than 2-3 mm wider than the dural borders. The facet joints are not exposed. Finally, the split spionous processes are sutured together. No collar or restrictions will be used in either group.
Laminectomy with instrumented fusion with a midline incision over the appropriate levels defined as the same levels as the extension of laminectomy plus one level above and below but not extending beyond C3-C7. Soft tissue dissection and retraction is performed to identify osseous landmarks. Special care is taken to spare muscle attachments on C2 and C7. Spinal instrumentation is performed with lateral mass or pedicle screws (C3-C7) combined with rod fixation. Laminectomy is performed with a width not extending more than 2 mm outside the dural borders. Facet joint injury should be avoided. Special care is taken to spare the C7 spinous process and distal half of C7 lamina. The sagittal alignment is corrected before spinal fixation. No collar or restrictions will be used in either group.