CSS-Assessing the Course of Degenerative Cervical Spinal Stenosis Using Functional Outcomes
NCT ID: NCT04381663
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
60 participants
OBSERVATIONAL
2019-09-16
2025-09-30
Brief Summary
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* In Study A, objectively assessed physical activity, gait, balance, range of movement of specific joints during walking and neurophysiological findings between patients with cervical spine stenosis (CSS) without myelopathy who will be treated conservatively and patients with stenosis and signs of myelopathy who are candidates for surgical Treatment will be compared.
* In Study B, the 6-month changes in the same outcomes in patients treated conservatively (from the first specialist consultation until 6 months later) and in patients treated surgically (preoperative day and 6-month post-operatively) will be quantified.
Detailed Description
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Study B is a single centre longitudinal study where the same patient groups will be followed up during the course of their treatment.
Clinical, radiological, biomechanical (kinematic and electromyographic), neurological and neurophysiological data will be collected. Differences in and the relationship between the clinical, radiological, biomechanical, neurological and neurophysiological data will be determined .
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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conservative treatment
In study A this group will be treated conservatively (stenosis). Study B is a single centre longitudinal study where the same patient groups will be followed up during the course of their treatment
conservative treatment
conservative treatment for patients with cervical spine stenosis without myelopathy
surgical treatment (stenosis and myelopathy).
In study A this group that will be treated surgically (stenosis and myelopathy). Study B is a single centre longitudinal study where the same patient groups will be followed up during the course of their treatment
surgical treatment
surgical decompress the spinal canal in patients with moderate to severe degenerative cervical spine myelopathy
Interventions
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conservative treatment
conservative treatment for patients with cervical spine stenosis without myelopathy
surgical treatment
surgical decompress the spinal canal in patients with moderate to severe degenerative cervical spine myelopathy
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of degenerative cervical spine stenosis defined by MRI (stenosis grade 2 or grade 3
* Local clinical symptoms due to degenerative changes of the cervical vertebral column with or without clinically defined myelopathy
Exclusion Criteria
* Prior decompressive surgery
* Previous spine or extremity surgery with a consequent sensorimotor impairment
* Other pathologies than cervical spine stenosis causing gait disturbance
* BMI \> 35 kg/m2
* Use of walking aids
* Inability to provide informed consent
* Contraindications for recording of Motor evoked potentials (MEP)
* Contraindications to safely undergo MRI
18 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Annegret Mündermann, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Cordula Netzer, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Regina Schläger, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Martin Hardmeier, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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Universitätsspital Basel
Basel, , Switzerland
Countries
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Other Identifiers
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2019-01270;ch20Muendermann
Identifier Type: -
Identifier Source: org_study_id