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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01247948

Acronym

J0001I41

Enrollment

656

Registered

2010-11-25

Start date

2011-02-28

Completion date

2012-02-29

Last updated

2010-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pedicle Screw of Fixation

Keywords

pedicle screw of fixation operation, spine surgery, navigation assisted

Brief summary

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

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.

Interventions

PROCEDUREnavigation assisted spine surgery

navigation assisted pedicle screw placement of spine surgery

PROCEDUREtraditional spine surgery

traditional spine surgery without navigation assist

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
complication	three days after the spine surgery	the complication would be recorded three days after the spine surgery

Contacts

Primary ContactWei Tian, doctor

xiaohan_007@163.com861058516538

Backup ContactYanwei Lv, master