Trials / Enrolling By Invitation
Enrolling By InvitationNCT04381663
CSS-Assessing the Course of Degenerative Cervical Spinal Stenosis Using Functional Outcomes
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (estimated)
- Sponsor
- University Hospital, Basel, Switzerland · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
The study will consist of two parts: * 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
Study A is a single centre cross-sectional study with two study groups, one that will be treated conservatively (stenosis) and one 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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | conservative treatment | conservative treatment for patients with cervical spine stenosis without myelopathy |
| PROCEDURE | surgical treatment | surgical decompress the spinal canal in patients with moderate to severe degenerative cervical spine myelopathy |
Timeline
- Start date
- 2019-09-16
- Primary completion
- 2025-09-01
- Completion
- 2025-09-01
- First posted
- 2020-05-11
- Last updated
- 2024-12-09
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT04381663. Inclusion in this directory is not an endorsement.