Evaluating the Accuracy of Navigation Assisted Pedicle Screw Placement of Spine Surgery (J0001I41)

December 9, 2010 updated by: Beijing Jishuitan Hospital

A Multi-center Randomized Controlled Trial Evaluating the Accuracy of Navigation Assisted Pedicle Screw Placement of Spine Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

656

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: navigation assisted spine surgery
Procedure: navigation assisted spine surgery
navigation assisted pedicle screw placement of spine surgery
Other Names:
  • navigation assisted pedicle screw placement of spine surgery
Procedure: traditional spine surgery
traditional spine surgery without navigation assist
Other Names:
  • traditional spine surgery without navigation assist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the accuracy of pedicle screw
Time Frame: one week after the spine surgery
one week after the spine surgery,measure the accuracy of pedicle screw by CT examination
one week after the spine surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complication
Time Frame: three days after the spine surgery
the complication would be recorded three days after the spine surgery
three days after the spine surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Jishuitan Hospital

Investigators

  • Study Chair: Wei Tian, doctor, Beijing Jishuitan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

February 1, 2012

Study Registration Dates

First Submitted

November 23, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimate)

November 25, 2010

Study Record Updates

Last Update Posted (Estimate)

December 10, 2010

Last Update Submitted That Met QC Criteria

December 9, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • jst2010caos
  • jstssrct001 (Other Identifier: Beijing Jishuitan Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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