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

NCT04381663 | Enrolling By Invitation

• 1 other identifier: 2019-01270;ch20Muendermann
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Spinal Stenosis; Cervical Myelopathy

Keywords

Cervical Spinal Stenosis; Cervical 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 treatment PROCEDURE

conservative treatment for patients with cervical spine stenosis without myelopathy

conservative treatment

surgical treatment PROCEDURE

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

surgical treatment (stenosis and myelopathy).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with degenerative cervical spine stenosis with or without myelopathy.

You may qualify if:

• Age \> 18 years
• 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

You may not qualify if:

• Stenosis after trauma or neoplasm
• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Universitätsspital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

Conservative Treatment; Surgical 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
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

CH (1)