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

Beijing Jishuitan Hospital

Status: Unknown

Conditions: Pedicle Screw of Fixation

Treatments: Procedure: traditional spine surgery; Procedure: navigation assisted spine surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01247948

jstssrct001 (Other Identifier)

jst2010caos

Details and patient eligibility

About

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.

Full 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.

Enrollment: 656 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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656 participants in 1 patient group

navigation assisted spine surgery

Experimental group

Treatment:

Procedure: navigation assisted spine surgery

Procedure: traditional spine surgery