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A randomized controlled study on the treatment effect of complex ZMC with navigation and guide plate technology

Clinical randomized controlled study on the treatment effect of complex ZMC with navigation and guide plate technology

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INC-17012496
Enrollment
Unknown
Registered
2017-08-28
Start date
2018-01-01
Completion date
Unknown
Last updated
2017-09-04

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

Conditions

complicated zygomatic-maxillary complex catagma

Interventions

computer assisted navigation group:computer aided surgery
surgical stent group:Surgical Guide aided surgery

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Subjects were aged between 18 and 60 years old, with unlimited gender; 2. Due to the complex fracture caused by the maxillofacial trauma, Zingg classified class B and C fracture; 3. Failure to participate in other clinical trials within 3 months; 4. Without acute infectious disease, mental illness or systemic disease; 5. CT scan is required for diagnosis or treatment; 6. Voluntary trial and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) With severe craniocerebral injury, vital signs are unstable; (2) Zingg classified class A fracture; (3) There are other systemic diseases; (4) Allergic to plant of titanium alloy; (5) Acute or severe infection or chronic infection in patients with acute onset; (6) The operation results in a wide range of soft tissue defects, and the postoperative wound has not enough soft tissue coverage; (7) Radiological osteomyelitis, acute chronic osteomyelitis, osteoporosis patients; (8) Patients with primary diseases such as heart, lung, brain or kidney were not controlled; (9) Mentally ill; (10) Pregnant or lactating women; (11) Patients who cannot cooperate with the treatment; (12) Patients with Middle and late malignant tumor, tumor distant metastasis or tumor recurrence patients; (13) Patients who are in critical condition are difficult to evaluate the efficacy and safety of the plants.

Design outcomes

Primary

MeasureTime frame
Accuracy of the mandible restoration;

Secondary

MeasureTime frame
intraoperative blood loss;operation time;Preoperative preparation time;operative complications;

Countries

China

Contacts

Public ContactYu Hongbo

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

yhb3508@163.com+86 13818350397

Outcome results

None listed

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