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A randomized, self-controlled clinical trial of the safety and efficacy of a combined impedance-angle spinal measurement probe in posterior spinal surgery

A randomized, self-controlled clinical trial of the safety and efficacy of a combined impedance-angle spinal measurement probe in posterior spinal surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101242
Enrollment
Unknown
Registered
2025-04-22
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Spinal Diseases

Interventions

containment:Conventional pedicle openers
experimental:Combined impedance-angle spinal measurement probe

Sponsors

Shanxi Baiqun Hospital Shanxi Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age 18 to 80 years old, gender is not limited; (2) Patients who did not have vertebral arch defects on preoperative CT scan; (3) Subjects who can understand the purpose of the trial, who voluntarily participate and sign the informed consent form, and who are willing to be followed up.

Exclusion criteria

Exclusion criteria: (1) Patients in the presence of acute spinal infection or patients with severe osteoporosis; (2) Patients with absent pedicles by preoperative CT scan; (3) Patients who are not suitable for bilateral pedicle screw fixation; (4) Patients with implanted pacemakers or other active medical devices, etc; (5) Patients with systemic diseases such as coagulation disorders that cannot be treated surgically; (6) Patients who are also participating in other clinical trials; (7) Women who are pregnant or breastfeeding; (8) Those who are considered by the investigator to be unsuitable for participation in the clinical trial (e.g., patients with mental or emotional problems, patients with hearing, reading and writing disorders, patients with family members who oppose the trial, patients with high expectations of treatment, patients who require excessive financial assistance, etc.).

Design outcomes

Primary

MeasureTime frame
Accuracy of pedicle screw implantation;

Secondary

MeasureTime frame
Nail angle deviation;Mean pedicle channel preparation time per group;Cerebrospinal fluid leak;nerve damage;

Countries

China

Contacts

Public ContactXing Zejun

Shanxi Baiqun Hospital Shanxi Academy of Medical Sciences

gaoxiaojin@foxmail.com+86 187 3513 0965

Outcome results

None listed

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