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Evaluation of effectiveness and safety of orthopaedic surgical navigation system—Multicenter, randomized, open, parallel controlled clinical trial

Evaluation of effectiveness and safety of orthopaedic surgical navigation system—Multicenter, randomized, open, parallel controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059473
Enrollment
Unknown
Registered
2022-04-30
Start date
2021-12-02
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

pelvic fracture

Interventions

Experimental group:Pelvic fracture patients with closed reduction and internal fixation by the need to random experimental apparatus
Control group:Pelvic fracture patients with closed reduction and internal fixation by traditional operation method

Sponsors

Beijing Jishuitan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-80 years old, gender is not limited; 2. Closed unstable pelvic ring injury requiring reduction (Tile type B or C); 3. The expected surgical treatment time is within 2 weeks from the fracture occurrence time; 4. The subjects fully understand the benefits and risks of this trial, are willing to participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Serious open injury or rupture of abdominal pelvic cavity and organs with wound contamination; 2. Subjects with bilateral fractures and significant displacement, so that it is impossible to use the orthopedic surgical navigation system to complete the surgical planning; 3. The vital signs are not stable enough, and may not be able to tolerate anesthesia or surgery after evaluation by the investigator; 4. The local skin condition is not good, or the site where the implant is expected to be inserted or the soft tissue around it is infected; 5. Systemic diseases, such as severe bleeding disorders, severe heart disease and severe respiratory diseases; 6. Pathological fracture (such as primary or metastatic tumor) or revision surgery (such as malunion, nonunion or infection); 7. The patient has contraindications to anesthesia and surgery; 8. Patients are currently receiving chemotherapy or radiotherapy, systemic application of corticosteroids or growth factors; 9. The patient has problems such as drug abuse, schizophrenia, dementia, etc., and the researcher judges that the experiment cannot be completed according to the research plan; 10. Family planning, lactating and pregnant women throughout the clinical research period; 11. Patients who have participated in or are currently participating in clinical trials of other drugs or medical devices within the past month; 12. The investigator believes that it is not suitable to participate in this clinical trial due to other reasons.

Design outcomes

Primary

MeasureTime frame
Excellent and good rate of pelvic closed reduction;

Secondary

MeasureTime frame
Reduction accuracy;Number of fluoroscopy;Functional score;Fracture healing rate;Evaluation of the functional, stability and convenience of the whole machine;Evaluation of the use of matching tools;

Countries

China

Contacts

Public ContactWu Xinbao

Beijing Jishuitan Hospital

wuxinbao_jst@126.com+86 137 0126 5110

Outcome results

None listed

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