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Fusion or no Fusion After Decompression of the Spinal Cord in Patients With Degenerative Cervical Myelopathy

RecruitingNAAges 18 Years - anyAllUppsala University Hospital
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In plain words

What the trial is, and whether it could suit you

Background: Degenerative cervical myelopathy (DCM) is characterized by neck pain, neck stiffness, weakness, paresthesia, sphincter disturbance and balance disorder. The mean age for symptoms is 64 years and more men than women, 2.7:1, are affected. The most common level is C5-C6. DCM is the predominant cause of spinal cord dysfunction in the elderly worldwide. Surgical options include stand-alone laminectomy, laminectomy and fusion and laminoplasty. The preferable surgical approach is though, a matter of controversy. The objective of this study is to compare stand-alone laminectomy to laminectomy and fusion. Methods/Design: This is a multicenter randomized, controlled, parallel group non-inferiority trial. A total of 300 adult participants are allocated in a ratio of 1:1. The primary endpoint is reoperation for any reason within 5 years of follow-up. Sample size and power calculations

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Muscle preserving selective laminectomy
  • Laminectomy with instrumented fusion
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Where

1 site
Academic Hospital of Uppsala
Uppsala, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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