NCT04936074 Fusion or no Fusion After Decompression of the Spinal Cord in Patients With Degenerative Cervical Myelopathy
| NCT ID | NCT04936074 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uppsala University Hospital |
| Condition | Cervical Spondylotic Myelopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-02-21 |
| Primary Completion | 2030-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2022-02-21 with a primary completion date of 2030-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 were performed by estimating the reoperation rate after laminectomy to 3.4% and after laminectomy with fusion to 7.9% based on data from the Swedish spine registry (Swespine) on patients with DCM. Secondary outcomes are the patient derived modified Japanese orthopaedic association (P-mJOA) score, Neck disability index (NDI), European quality of life five dimensions (EQ-5D), Numeric rating scale (NRS) for neck and arm pain, Hospital anxiety and depression scale (HADS), development of kyphosis measured as the cervical sagittal vertical axis (cSVA) and, death. Clinical and radiological follow-up is performed at 3, 12, 24 and 60 months after surgery. The main inclusion criteria is 1-4 levels of DCM in the subaxial spine, C3-C7, with or without deformity. The REDcap will be used for safe data management. Data will be analyzed in the per protocol (PP) population, defined as randomized patients who are still alive without having emigrated or left the study after five years. Discussion: This will be the first randomized controlled trial comparing two of the most common surgical treatments for DCM; the posterior muscle-preserving selective laminectomy and posterior laminectomy with instrumented fusion. The results of the MyRanC study will provide surgical treatment recommendations for DCM. This may result in improvements in surgical treatment and clinical practice regarding DCM.
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
Contact & Investigator
Anna MacDowall, MD, PhD
PRINCIPAL INVESTIGATOR
Uppsala University Hospital
Frequently Asked Questions
Who can join the NCT04936074 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cervical Spondylotic Myelopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04936074 currently recruiting?
Yes, NCT04936074 is actively recruiting participants. Contact the research team at anna.macdowall@surgsci.uu.se for enrollment information.
Where is the NCT04936074 trial being conducted?
This trial is being conducted at Uppsala, Sweden.
Who is sponsoring the NCT04936074 clinical trial?
NCT04936074 is sponsored by Uppsala University Hospital. The principal investigator is Anna MacDowall, MD, PhD at Uppsala University Hospital. The trial plans to enroll 300 participants.