Tuberculosis, Spinal Clinical Trial
Official title:
The Study of Standardized Preoperative Anti-tuberculosis Treatment of Surgical Treatment of Spinal Tuberculosis Patients
The purpose of this study is to determine the better preoperative anti-tuberculosis treatment period of patients with spinal tuberculosis.
Quality assurance plan：All the investigators will receive uniform training. Standard cases
follow-up,collection,management systems will be established.The process of cases
follow-up,collection,management will be supervised by the third party.Data entry will be in
the manner of independent parallel entry.The endpoints events are judged by third
party.Statistical analysis are implemented by the statistics institutions of the third
party.In order to control the bias,this study takes multicenter,random,control study design.
Sample size assessment:Under the condition of multicenter,random,control design,
computational formula takes the rate comparisons of two groups.The key endpoints event is
soft tissue width of vertebral side measured by computed tomography. The incidence of the
key endpoints event in two weeks group is 30%.The incidence of the key endpoints event in
four weeks group is 15%.When alpha value is 0.5 and power value is 0.9,the sample size is
161 patients.If loses visit rate is 20%,the sample size is 194 patients.
Statistical analysis plan:The key events are analyzed by chi-squared test.The statistical
significance factors among them are calculated by relative risk.
Data checks and source data verification are supervised by a third-party organization
(contract research organization，CRO).
Standard Operating Procedures:Investigator's brochure has explained in detail about the
standard operating procedures of everything.Data dictionary can be found in standard
operating procedures.
Plan for missing data: The investigators Set a 20% rate of lost to follow-up.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05610098 -
Gene Expression Profiles in Spinal Tuberculosis.
|