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NCT05446259 Clinical Trial

Degenerative Cervical Myelopathy Repository

Cervical Myelopathy Clinical Trial

— DCM  

Official title:
Development of a Predictive Outcome Model for Patients With Degenerative Cervical Myelopathy Using Objective Functional and Biological Measures.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05446259
Other study ID # 78340
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 13, 2022
Est. completion date May 2028

Study information
Verified date July 2023
Source University of Kentucky
Contact Francis Farhadi, MD, PhD
Phone 859-562-0247
Email francis.farhadi@uky.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To create a research repository of patients with known degenerative cervical myelopathy (DCM) and a control cohort of subjects who have non-myelopathic spinal disease. This repository will be used to assess functional and/or biological measures that may allow for improved prediction of symptomatic progression and response to treatment in patients with DCM. In addition, this repository will be used to develop a risk assessment scale to accurately predict functional outcomes following operative management of DCM.

Recruitment information / eligibility
Status Recruiting
Enrollment 245
Est. completion date May 2028
Est. primary completion date June 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Diagnosis of degenerative cervical myelopathy - Diagnosis of cervical degenerative disease without myelopathy Exclusion Criteria: - None outside or diagnostic requirements and age limits.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Standard clinical care procedures and outcome measurements.
Standard of care surgical interventions, imaging impressions, laboratory results, and outcome measurements will be collected and analyzed.

Locations
Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (1)
Lead Sponsor Collaborator
University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Data comparison between DCM and control groups This study is to determine biomarkers associated with DCM and analyze objective clinical measures to determine more predictable and potentially effective treatments for patients diagnosed with cervical myelopathy. 2 years
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