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Safety and accuracy of robot-assisted pedicle screw fixation: A randomized controlled trial

Safety and efficacy of the surgical navigation positioning system in spinal surgery: A multicenter, randomized, parallel-controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121746
Enrollment
Unknown
Registered
2026-04-02
Start date
2021-03-11
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Spine disorders

Interventions

Experimental:Robot-assisted surgery
Control:Conventional fluoroscopy-guided surgery

Sponsors

Shanghai Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Eligible participants were adults scheduled to undergo open or minimally invasive fluoroscopy-guided pedicle screw fixation: (1) age between 18 and 80 years; (2) no restriction on sex; (3) provision of signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Known allergy to metal or multiple drugs; (2) Pregnancy or lactation; (3) Coagulation disorders; (4) Prior failed spinal surgery at the same segment; (5) Participation in other clinical trials involving drugs or devices within the past 3 months; (6) Pedicle deformity; (7) Other conditions deemed by investigators to preclude participation.

Design outcomes

Primary

MeasureTime frame
deviation of the guide pin;—

Secondary

MeasureTime frame
intraoperative radiation exposure;procedural efficiency;—

Countries

China

Contacts

Public ContactLiming Cheng

Shanghai Tongji Hospital

limingcheng@tongji.edu.cn+86 21 6611 1706

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026