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Evaluating the Accuracy of Navigation Assisted Pedicle Screw Placement of Spine Surgery

NCT ID: NCT01247948

Last Updated: 2010-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

656 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Pedicle Screw of Fixation

Keywords

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pedicle screw of fixation operation spine surgery navigation assisted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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navigation assisted spine surgery

Group Type EXPERIMENTAL

navigation assisted spine surgery

Intervention Type PROCEDURE

navigation assisted pedicle screw placement of spine surgery

traditional spine surgery

Intervention Type PROCEDURE

traditional spine surgery without navigation assist

Interventions

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navigation assisted spine surgery

navigation assisted pedicle screw placement of spine surgery

Intervention Type PROCEDURE

traditional spine surgery

traditional spine surgery without navigation assist

Intervention Type PROCEDURE

Other Intervention Names

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navigation assisted pedicle screw placement of spine surgery traditional spine surgery without navigation assist

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Jishuitan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Beijing Jishuitan Hospital

Principal Investigators

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Wei Tian, doctor

Role: STUDY_CHAIR

Beijing Jishuitan Hospital

Central Contacts

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Wei Tian, doctor

Role: CONTACT

Phone: 861058516538

Email: [email protected]

Yanwei Lv, master

Role: CONTACT

Phone: 861058516538

Email: [email protected]

Other Identifiers

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jstssrct001

Identifier Type: OTHER

Identifier Source: secondary_id

jst2010caos

Identifier Type: -

Identifier Source: org_study_id