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A randomized, controlled, multicenter clinical trial of spine needle assisted for pedicle screw inplantation

A randomized, controlled, multicenter clinical trial of spine needle assisted for pedicle screw inplantation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016744
Enrollment
Unknown
Registered
2018-06-21
Start date
2018-06-08
Completion date
Unknown
Last updated
2018-06-25

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

Conditions

Spine diseases

Interventions

Control:Free hand technique
Experimental:spine needle

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) aged 10-80 years old male or female; 2) first time to undergo spinal fixation surgery, and the pedicle screw inplanted is included from T1 to S1; 3) Be able to understand and voluntarily participate in this clinical trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) the operating segments of the vertebrae has pathology changes that cause significant changes in the electrical impedance (such as tumors and fractures in the operating site); 2) Pregnant and lactating women; 3) Patients who have undergone spinal fusion at the stage of the operation; 4) Participation in other clinical trials at the same time; 5) Not appropriate to participate in this clinical trial; 6) Other navigation methods are used during the surgery; 7) Patients with heart pacemakers or other active medical equipment;

Design outcomes

Primary

MeasureTime frame
Accuracy of pedicle screw placement ;Number of intraoperative X - rays times;

Secondary

MeasureTime frame
The time of setting each pedicle screw;

Countries

China

Contacts

Public ContactYu-Shu Bai

800 Changhai Road, Yangpu District, Shanghai, China

jsjyzx8@qq.com+86 13764549997

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026