Comparing two surgical methods for treating neck problems caused by spinal cord compression
Comparison of Posterior Muscle-preserving Selective Laminectomy and Laminectomy With Fusion for Treating Degenerative Cervical Myelopathy: Myelopathy Randomized Controlled Trial (MyRanC)
NA · Uppsala University Hospital · NCT04936074
This study is testing which surgery works better for older adults with neck problems caused by spinal cord compression: a simpler surgery or one that includes adding a fusion.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University Hospital (other) |
| Locations | 1 site (Uppsala) |
| Trial ID | NCT04936074 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of stand-alone laminectomy versus laminectomy with fusion in patients suffering from degenerative cervical myelopathy. It is a multicenter, randomized, controlled trial involving 300 adult participants who will be followed for five years to assess the need for reoperation. The study focuses on patients with symptomatic myelopathy and evaluates outcomes related to surgical intervention. The trial seeks to clarify the best surgical approach for this common condition affecting the elderly.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with symptomatic degenerative cervical myelopathy affecting 1-4 levels of the cervical spine.
Not a fit: Patients with previous spine surgery or significant spinal deformities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the most effective surgical treatment for degenerative cervical myelopathy, potentially improving patient outcomes and reducing the need for reoperations.
How similar studies have performed: While there have been various approaches to treating degenerative cervical myelopathy, this specific comparison of laminectomy versus laminectomy with fusion is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Uppsala
- Academic Hospital of Uppsala — Uppsala, Sweden (RECRUITING)
Study contacts
- Principal investigator: Anna MacDowall, MD, PhD — Uppsala University Hospital
- Study coordinator: Anna MacDowall, MD, PhD
- Email: anna.macdowall@surgsci.uu.se
- Phone: +46 730687087
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cervical Spondylotic Myelopathy, Cervical fusion, Cervical spine, Laminectomy, Spinal surgery, Randomized controlled trial