Evaluating the Accuracy of Navigation Assisted Pedicle Screw Placement of Spine Surgery (J0001I41)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Beijing Jishuitan Hospital.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Beijing Jishuitan Hospital
Information provided by:
Beijing Jishuitan Hospital
ClinicalTrials.gov Identifier:
NCT01247948
First received: November 23, 2010
Last updated: December 9, 2010
Last verified: November 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pedicle Screw of Fixation |
Procedure: navigation assisted spine surgery Procedure: traditional spine surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multi-center Randomized Controlled Trial Evaluating the Accuracy of Navigation Assisted Pedicle Screw Placement of Spine Surgery |
Further study details as provided by Beijing Jishuitan Hospital:
Primary Outcome Measures:
- the accuracy of pedicle screw [ Time Frame: one week after the spine surgery ] [ Designated as safety issue: Yes ]one week after the spine surgery,measure the accuracy of pedicle screw by CT examination
Secondary Outcome Measures:
- complication [ Time Frame: three days after the spine surgery ] [ Designated as safety issue: Yes ]the complication would be recorded three days after the spine surgery
| Estimated Enrollment: | 656 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: navigation assisted spine surgery |
Procedure: navigation assisted spine surgery
navigation assisted pedicle screw placement of spine surgery
Other Name: navigation assisted pedicle screw placement of spine surgery
Procedure: traditional spine surgery
traditional spine surgery without navigation assist
Other Name: traditional spine surgery without navigation assist
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who need to undergo pedicle screw fixation surgery
- Sign informed consent
- Capacity person
Exclusion Criteria:
- refused to sign the informed consent
- the age is not between 18 and 75 years old
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247948
Contacts
| Contact: Wei Tian, doctor | 861058516538 | xiaohan_007@163.com |
| Contact: Yanwei Lv, master | 861058516538 | xiaohan_007@163.com |
Sponsors and Collaborators
Beijing Jishuitan Hospital
Investigators
| Study Chair: | Wei Tian, doctor | Beijing Jishuitan Hospital |
More Information
No publications provided
| Responsible Party: | Tian Wei ,director of the hospital, Beijing Jishuitan Hospital |
| ClinicalTrials.gov Identifier: | NCT01247948 History of Changes |
| Other Study ID Numbers: | jst2010caos, jstssrct001 |
| Study First Received: | November 23, 2010 |
| Last Updated: | December 9, 2010 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Beijing Jishuitan Hospital:
|
pedicle screw of fixation operation spine surgery navigation assisted |
ClinicalTrials.gov processed this record on May 22, 2013