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
Sponsor:
Information provided by:
Beijing Jishuitan Hospital
ClinicalTrials.gov Identifier:
NCT01247948
First received: November 23, 2010
Last updated: December 9, 2010
Last verified: November 2010
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014