Cervical Myelopathy
Conditions
Keywords
limaprost alfadex, cervical myelopathy, surgery
Brief summary
The limaprost alfadex can improve the surgical outcomes in patients with cervical myelopathy.
Interventions
DRUGLimaprost
taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day
DRUGPlacebo
taking placebo drug
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Older than 20 years old * Compressive cervical myelopathy, confirmed by MRI, including C1-C2 instability, ossification of posterior longitudinal ligament * Plan to undergo cervical surgery for myelopathy * JOA score less than 15 points * Signed informed consent of patient or legal guardian
Exclusion criteria
* Infection or malignancy * Taking Limaprost before surgery * Pregnancy or expected to be pregnant or breast feeding * severe cardiovascular, pulmonary, renal disease or distress, brain pathology * any related coagulopathy * any drug to cause bleeding tendency * severe pain from other disease * 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 * patient cannot follow study protocol, for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Japanese Orthopedic Association (JOA) recovery rates | up to 12 months after operation | JOA recovery rate = \[(postoperative JOA score) - (preoperative JOA score)\] / \[(17-(preoperative JOA score)\] x 100 (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neck disability index score | up to 12 months after operation | — |
| Japanese orthopaedic association Cervical Myelopathy Evaluation Questionnaire score | up to 12 months after operation | — |
| Visual Analog Pain Scale for neck pain | up to 12 months after operation | — |
| Japanese orthopaedic association score | up to 12 months after surgery | — |
| assessment of the efficacy of positron emission tomography (PET) | up to 12 months after operation | The assessment of the efficacy of PET for prediction of drug (Limaprost) effect |
| Questionnaire Short Form 12 | up to 12 months after operation | — |
Countries
South Korea
Outcome results
None listed