Trials Sponsors Conditions Drugs Pricing

Conditions

Cervical Myelopathy Cervical Spinal Stenosis

Keywords

Cervical Spinal StenosisCervical Myelopathy

Outcome Measures

Primary Outcomes (3)

Difference in gait symmetry
The subjects will perform an instrumented gait analysis on an overground walkway with two embedded force plates
approximate duration: 30 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2
Change in balance performance
Balance performance will be assessed using the modified clinical test of sensory integration of balance (m-CTSIB) using the Biodex Balance System SD
approximate duration: 30 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.
Difference in neurophysiological outcome
Quantitative score of Motor evoked potentials (MEP) and Somato-sensory evoked potentials (SEP)
approximate duration: 30 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.

Secondary Outcomes (10)

Difference in daily physical activity
monitored for 7 consecutive days at visit 1 or 1 week before surgery and 6 months later at visit 2
Difference in spinal cord gray and white matter areas
approximate duration of the scan: 30. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2 (Measurement at visit 2 only in patients with cervical spine stenosis treated conservatively).
Change in segmental quantitative muscle strength
approximate duration: 10 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.
Change in 25-foot walk test
approximate duration: 3 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.
Change in 6-minute walk test
approximate duration: 6 minutes. Assessment will be performed at visit 1 and will be repeated 6 months after study inclusion at visit 2.

Study Arms (2)

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

Procedure: conservative treatment

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

Procedure: surgical treatment

Interventions

conservative treatmentProcedure

conservative treatment for patients with cervical spine stenosis without myelopathy

conservative treatment

surgical treatmentProcedure

surgical decompress the spinal canal in patients with moderate to severe degenerative cervical spine myelopathy

surgical treatment (stenosis and myelopathy).

Eligibility Criteria

Age18 Years+

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Patients with degenerative cervical spine stenosis with or without myelopathy.

You may qualify if:

Age \> 18 years

Sponsors & Collaborators

University Hospital, Basel, Switzerland
Otherlead

Study Sites (1)

Universitätsspital Basel

Basel, 4031, Switzerland

MeSH Terms

Interventions

Conservative TreatmentSurgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

Annegret Mündermann, Prof. Dr.
University Hospital, Basel, Switzerland
PRINCIPAL INVESTIGATOR
Cordula Netzer, Dr. med.
University Hospital, Basel, Switzerland
PRINCIPAL INVESTIGATOR
Regina Schläger, PD Dr. med.
University Hospital, Basel, Switzerland
PRINCIPAL INVESTIGATOR
Martin Hardmeier, PD Dr. med.
University Hospital, Basel, Switzerland
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: OTHER
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 11, 2020

Study Start

September 16, 2019

Actual (reported)

Primary Completion

September 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

CSS-Assessing the Course of Degenerative Cervical Spinal Stenosis Using Functional Outcomes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (10)

Study Arms (2)

conservative treatment

surgical treatment (stenosis and myelopathy).

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (10)

Study Arms (2)

conservative treatment

surgical treatment (stenosis and myelopathy).

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations