The Study About the Efficacy of Oral Limaprost After Surgery for Cervical Myelopathy
Last updated on April 2022Recruitment
- Recruitment Status
- Recruiting
Inclusion Criteria
- Older than 20 years old
- JOA score less than 15 points
- Plan to undergo cervical surgery for myelopathy
- ...
- Older than 20 years old
- JOA score less than 15 points
- Plan to undergo cervical surgery for myelopathy
- Signed informed consent of patient or legal guardian
- Compressive cervical myelopathy, confirmed by MRI, including C1-C2 instability, ossification of posterior longitudinal ligament
Exclusion Criteria
- 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
- Infection or malignancy
- Taking Limaprost before surgery
- ...
- 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
- Infection or malignancy
- Taking Limaprost before surgery
- patient cannot follow study protocol, for any reason
- severe cardiovascular, pulmonary, renal disease or distress, brain pathology
- severe pain from other disease
- any related coagulopathy
- Pregnancy or expected to be pregnant or breast feeding
- any drug to cause bleeding tendency
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
- Older than 20 years old
- JOA score less than 15 points
- Plan to undergo cervical surgery for myelopathy
- ...
- Older than 20 years old
- JOA score less than 15 points
- Plan to undergo cervical surgery for myelopathy
- Signed informed consent of patient or legal guardian
- Compressive cervical myelopathy, confirmed by MRI, including C1-C2 instability, ossification of posterior longitudinal ligament
Exclusion Criteria
- 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
- Infection or malignancy
- Taking Limaprost before surgery
- ...
- 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
- Infection or malignancy
- Taking Limaprost before surgery
- patient cannot follow study protocol, for any reason
- severe cardiovascular, pulmonary, renal disease or distress, brain pathology
- severe pain from other disease
- any related coagulopathy
- Pregnancy or expected to be pregnant or breast feeding
- any drug to cause bleeding tendency
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
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