Pedicle Screw of FixationJ0001I41NCT01247948
Evaluating the Accuracy of Navigation Assisted Pedicle Screw Placement of Spine Surgery
A study testing navigation assisted spine surgery and traditional spine surgery in people with Pedicle Screw of Fixation, run by Beijing Jishuitan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pedicle Screw of Fixation
- What is being tested?
- navigation assisted spine surgery and traditional spine surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 656 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who need to undergo pedicle screw fixation surgery
- Sign informed consent
- Capacity person
Who cannot join
- refused to sign the informed consent
- the age is not between 18 and 75 years old
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pedicle Screw of Fixation
- Being tested
- navigation assisted spine surgery, traditional spine surgery
- Keywords
- pedicle screw of fixation operation, spine surgery, navigation assisted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
navigation assisted spine surgeryProcedure or surgery
Also called navigation assisted pedicle screw placement of spine surgery
navigation assisted pedicle screw placement of spine surgery
traditional spine surgeryProcedure or surgery
Also called traditional spine surgery without navigation assist
traditional spine surgery without navigation assist
| Study group | Role | What they receive |
|---|---|---|
| navigation assisted spine surgery | Experimental | Not described Receives: Procedure: navigation assisted spine surgery; Procedure: traditional spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
the accuracy of pedicle screw
one week after the spine surgery,measure the accuracy of pedicle screw by CT examination
Measured: one week after the spine surgery
Secondary outcomes (1)
complication
the complication would be recorded three days after the spine surgery
Measured: three days after the spine surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startFeb 2011
- Primary completionDec 2011 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pedicle Screw of FixationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 656 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wei Tian, doctor, Study chair, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247948
- Sponsor's protocol ID
- jst2010caos
- Other IDs
- jstssrct001
- Acronym
- J0001I41
- Status last verified
- Nov 2010
- First submitted
- 23 Nov 2010
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Controlled Trial Evaluating the Accuracy of Navigation Assisted Pedicle Screw Placement of Spine Surgery
- ClinicalTrials.gov ID
- NCT01247948
- Acronym / sponsor ID
- J0001I41 / jst2010caos
- Conditions
- Pedicle Screw of Fixation
- Keywords
- pedicle screw of fixation operation, spine surgery, navigation assisted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 656 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| navigation assisted spine surgery | Experimental | Procedure: navigation assisted spine surgery, Procedure: traditional spine surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who need to undergo pedicle screw fixation surgery
- Sign informed consent
- Capacity person
Key exclusion criteria (2 listed)
- refused to sign the informed consent
- the age is not between 18 and 75 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| navigation assisted spine surgeryAlso: navigation assisted pedicle screw placement of spine surgerynavigation assisted pedicle screw placement of spine surgery | Procedure or surgery | navigation assisted spine surgery |
| traditional spine surgeryAlso: traditional spine surgery without navigation assisttraditional spine surgery without navigation assist | Procedure or surgery | navigation assisted spine surgery |
Primary outcome
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
1 secondary outcome
complication
Time frame: three days after the spine surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2010.
Related trials for Pedicle Screw of Fixation
Active, not recruitingPhase 2
BDSF Vs DHS With Anterotational Screw in Vertical FNF
Evaluation of BDSF in FNF
RecruitingObservational study
Robotic-Assisted Pedicle Screw Placement in Spine Surgery
Pedicle Screw Fixation of Spine
Recruiting
Evaluation of Fracture Migration After Internal Fixation of Femoral Neck Fractures in Younger Adults: A Clinical RCT Using RSA
Femoral Neck Fractures, Internal Fixation; Complications
Recruiting
Artificial Intelligence-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck Screw Fixation
Femoral Neck Fractures
Active, not recruiting
Open Reduction in Femoral Neck Fractures
Femoral Neck Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Tian, doctor study chair
Beijing Jishuitan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing navigation assisted spine surgery and traditional spine surgery in people with Pedicle Screw of Fixation, run by Beijing Jishuitan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Tian, doctor (861058516538, xiaohan_007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the accuracy of pedicle screw (time frame: one week after the spine surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2010.