Recruitment

Recruitment Status
Recruiting

Inclusion Criterias

JOA score less than 15 points
Plan to undergo cervical surgery for myelopathy
Compressive cervical myelopathy, confirmed by MRI, including C1-C2 instability, ossification of posterior longitudinal ligament
...
JOA score less than 15 points
Plan to undergo cervical surgery for myelopathy
Compressive cervical myelopathy, confirmed by MRI, including C1-C2 instability, ossification of posterior longitudinal ligament
Signed informed consent of patient or legal guardian
Older than 20 years old

Exclusion Criterias

Infection or malignancy
any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study
severe pain from other disease
...
Infection or malignancy
any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study
severe pain from other disease
any drug to cause bleeding tendency
Taking Limaprost before surgery
severe cardiovascular, pulmonary, renal disease or distress, brain pathology
any related coagulopathy
patient cannot follow study protocol, for any reason
Pregnancy or expected to be pregnant or breast feeding

Summary

Conditions
Cervical Myelopathy
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 125 years
Gender
Both males and females

Inclusion Criterias

JOA score less than 15 points
Plan to undergo cervical surgery for myelopathy
Compressive cervical myelopathy, confirmed by MRI, including C1-C2 instability, ossification of posterior longitudinal ligament
...
JOA score less than 15 points
Plan to undergo cervical surgery for myelopathy
Compressive cervical myelopathy, confirmed by MRI, including C1-C2 instability, ossification of posterior longitudinal ligament
Signed informed consent of patient or legal guardian
Older than 20 years old

Exclusion Criterias

Infection or malignancy
any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study
severe pain from other disease
...
Infection or malignancy
any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study
severe pain from other disease
any drug to cause bleeding tendency
Taking Limaprost before surgery
severe cardiovascular, pulmonary, renal disease or distress, brain pathology
any related coagulopathy
patient cannot follow study protocol, for any reason
Pregnancy or expected to be pregnant or breast feeding

Locations

Seongnam-si, Gyeonggi-do, 463-707
Seongnam-si, Gyeonggi-do, 463-707

Tracking Information

NCT #
NCT02125981
Collaborators
Not Provided
Investigators
  • Principal Investigator: Jin S. Yeom Seoul National University Bundang Hospital
  • Jin S. Yeom Seoul National University Bundang Hospital