Recruitment

Recruitment Status
Recruiting

Inclusion Criteria

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

Exclusion Criteria

Pregnancy or expected to be pregnant or breast feeding
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
...
Pregnancy or expected to be pregnant or breast feeding
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
any drug to cause bleeding tendency
patient cannot follow study protocol, for any reason
severe cardiovascular, pulmonary, renal disease or distress, brain pathology
Taking Limaprost before surgery
any related coagulopathy
severe pain from other disease

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 Criteria

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

Exclusion Criteria

Pregnancy or expected to be pregnant or breast feeding
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
...
Pregnancy or expected to be pregnant or breast feeding
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
any drug to cause bleeding tendency
patient cannot follow study protocol, for any reason
severe cardiovascular, pulmonary, renal disease or distress, brain pathology
Taking Limaprost before surgery
any related coagulopathy
severe pain from other disease

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