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New treatment option for Cervical Spondylotic Myelopathy
Official title Fusion or no Fusion After Decompression of the Spinal Cord in Patients With Degenerative Cervical Myelopathy
ClinicalTrials.gov ID: NCT04936074
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>18 years
- 1-4 levels of cervical degenerative myelopathy in the subaxial spine, C3-C7, without or with deformity not exceeding
You likely can't join if
- , 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...
See the full eligibility criteria
- Age \>18 years
- 1-4 levels of cervical degenerative myelopathy in the subaxial spine, C3-C7, without or with deformity not exceeding
- , 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
The study team makes the final eligibility decision.
Where it's taking place
- Uppsala, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Uppsala, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.