Comparing two surgical methods for treating neck problems caused by spinal cord compression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.