Application of a novel mixed reality navigation technology in the distal interlocking of femoral intramedullary nails

Application of a novel mixed reality navigation technology in distal interlocking of femoral intramedullary nails: a prospective cohort study

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN34394615

Enrollment

Registered

2024-09-04

Start date

2024-07-01

Completion date

Unknown

Last updated

2026-08-31

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

Conditions

Femoral fractures (proximal femoral or femoral shaft fracture) Musculoskeletal Diseases

Interventions

This study primarily introduces a novel Mixed Reality (MR) navigation system and single-fluoroscopy calibration for distal interlocking of Intramedullary Nails (IMNs). A retrospective cohort study was

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with a primary femoral fracture diagnosis, including proximal femoral fracture or femoral shaft fracture. 2. Suitable for intramedullary nailing (IMN) treatment. 3. Willing to undergo mixed reality (MR) navigation-guided surgery.

Exclusion criteria

Exclusion criteria: 1. Severe trauma that precludes safe surgical intervention 2. Patients unwilling to participate in the MR navigation-guided surgery 3. Patients with contraindications for surgery 4. Individuals with severe comorbid conditions that could impact the outcome or safety of the surgical procedure 5. Patients with pre-existing conditions that could interfere with the use of MR technology, such as severe visual or cognitive impairments

Design outcomes

Primary

Measure	Time frame
The initial hit success rate is measured using data collected during the procedures as the number of successful cases on the first attempt to lock the distal holes during the process of using the MR-based three-dimensional spatial positioning technique for the distal interlocking holes of femoral IMNs, divided by the total number of cases attempting this method, at the timepoint immediately following the procedure	—

Measure

Time frame

The initial hit success rate is measured using data collected during the procedures as the number of successful cases on the first attempt to lock the distal holes during the process of using the MR-based three-dimensional spatial positioning technique for the distal interlocking holes of femoral IMNs, divided by the total number of cases attempting this method, at the timepoint immediately following the procedure

—

Secondary

Measure	Time frame
Hit success rate is measured using data collected during the procedures as the number of successful cases when attempting to lock the distal holes using the MR-based three-dimensional spatial positioning technique for the distal interlocking holes of femoral IMNs, divided by the total number of cases in the Mixed Reality Navigation Group (MR), at the timepoint immediately following the procedure	—

Countries

China

Contacts

Public ContactKe Lu

sgu8434@sina.com0086-0512-57532362

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Sep 19, 2026