Skip to content

A randomized controlled trial to evaluate the efficacy and safety of AR HOLONAVI S

A randomized controlled trial to evaluate the efficacy and safety of AR HOLONAVI S

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021878
Enrollment
Unknown
Registered
2019-03-14
Start date
2019-03-05
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

Spine

Interventions

Control Group:Traditional spinal surgery
Experimental group:spinal surgery under the guidance of AR HOLONAVI S

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged above 18 years, gender is not limited; 2. Requiring spinal screw placement; 3. Ability to understand and behave, and is able to participate in all study follow-ups and sign written informed form. 4. Complete the VAS score and JOA score.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women and those who are preparing to become pregnant in the near future; 2. Patients who have participated in other clinical trials within 3 months; 3. Systemic diseases, including:severe bleeding disorders, severe heart disease, severe respiratory diseases, other inability to tolerate anesthesia or surgery; 4. Cannot fulfill the positional requirements for spinal surgery; 5. Unable to receive intraoperative radiation; 6. Position of the tracer cannot meet the surgical requirements; 7. Unable to obtain image quality that meets the surgical requirements; 8. The investigator believes unsuitable.

Design outcomes

Primary

MeasureTime frame
Adverse event assessment;Accuracy of the position;

Secondary

MeasureTime frame
The operation time;radiation dose and radiation times;The volume of bleeding during the operation;Instrument failure times;Visualization and comfort of the AR glasses;

Countries

China

Contacts

Public ContactZhengdong Cai

Shanghai General Hospital

czd856@vip.163.com+86 13901832868

Outcome results

None listed

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