Evaluating the Accuracy of Navigation Assisted Pedicle Screw Placement of Spine Surgery
- Conditions
- Pedicle Screw of Fixation
- Interventions
- Procedure: navigation assisted spine surgeryProcedure: traditional spine surgery
- Registration Number
- NCT01247948
- Lead Sponsor
- Beijing Jishuitan Hospital
- Brief Summary
The purpose of this study is to investigate the difference of the accuracy and safety between traditional spine surgery and computer assisted navigation system spine surgery.
- Detailed Description
The object of study is the patients who are going to undergo pedicle screw fixation operation. there are two clinical trial centers.one is beijing jishuitan hospital,the other is beijing shuili hospital.the study protocol will be reviewed by the Ethics Committee of Beijing Jishuitan Hospital. after the patients sign the informed consent,they will be divided into two groups randomly.the patients' basic information and medical informations including the accuracy and safety will be collected.the data above all will be compared.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 656
- Patients who need to undergo pedicle screw fixation surgery
- Sign informed consent
- Capacity person
- refused to sign the informed consent
- the age is not between 18 and 75 years old
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description navigation assisted spine surgery navigation assisted spine surgery - navigation assisted spine surgery traditional spine surgery -
- Primary Outcome Measures
Name Time Method the accuracy of pedicle screw one week after the spine surgery one week after the spine surgery,measure the accuracy of pedicle screw by CT examination
- Secondary Outcome Measures
Name Time Method complication three days after the spine surgery the complication would be recorded three days after the spine surgery