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Efficacy and Safety Evaluation of Simultaneous and Staged Surgery for Midface FracturesCombined with Traumatic Brain Injury: A Multicenter Randomized Clinical Triale

Efficacy and Safety Evaluation of Simultaneous and Staged Surgery for Midface FracturesCombined with Traumatic Brain Injury: A Multicenter Randomized Clinical Triale

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128933
Enrollment
Unknown
Registered
2026-07-28
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Midfacial fractures combined with traumatic brain injury (TBI)

Interventions

Staged Surgery Group (SS):It is the "specialized and staged treatment model" currently routinely implemented in clinical practice. Specifically, the neurosurgery department prioritizes the treatment o
Multidisciplinary Simultaneous Surgery Group (MSS):Adopt the concurrent combined surgical treatment model, that is, during the same hospitalization and the same anesthesia stage, the neurosurgery depa

Sponsors

Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1. Patient age is 18-59 years (including 18 and 59). 2. No prior history of craniomaxillofacial surgery. 3. Craniomaxillofacial CT clearly diagnoses midface fractures (including isolated or combined zygomaticomaxillary complex fractures, maxillary fractures, naso-orbito-ethmoid fractures, orbital fractures, etc.), with obvious displacement that affects facial appearance, occlusal relationship, mouth opening, or other functions, requiring surgical treatment. 4. Neurosurgical clear diagnosis of: (1) Traumatic intracranial hemorrhage with large hematoma volume, increased intracranial pressure, or severe neurological dysfunction requiring surgery; (2) Skull base fracture with cerebrospinal fluid leakage requiring surgical repair; (3) Open skull fracture; (4) Closed skull fracture with severe depression, associated with neurological dysfunction, or fracture affecting appearance; (5) Diffuse brain swelling with increased intracranial pressure requiring surgical decompression; (6) Traumatic cranial nerve injury requiring surgery. 5. Patients with a preoperative Glasgow Coma Scale (GCS) score >=8.

Exclusion criteria

Exclusion criteria: 1.Patients whose injury occurred more than three days ago; 2.Patients with life-threatening traumatic brain injury who cannot tolerate prolonged surgery for maxillofacial fractures; 3.Patients with traumatic brain injury carrying a poor prognosis, such as brainstem injury, where there is a high likelihood of postoperative vegetative state; 4.Patients in poor general condition with severe systemic diseases, including acute infections, psychiatric disorders, and various serious systemic conditions such as hypertension, heart disease, and diabetes; 5.Patients with systemic or localized diseases that affect treatment outcomes, such as osteoporosis or osteomyelitis; 6.Pregnant or breastfeeding women; 7.Patients who are unable to cooperate with treatment;

Design outcomes

Primary

MeasureTime frame
Fracture Reduction Accuracy;Change in Glasgow Coma Scale (GCS) Score;

Secondary

MeasureTime frame
Nasolacrimal Duct Patency;Incidence of Postoperative Complications;Occlusion;Extraocular Muscle Function;Intraoperative Blood Loss;Total Medical Costs;Extended Glasgow Outcome Scale (GOSE);Length of Hospital Stay;Intercanthal Distance;Operative Time;Diplopia;Maximum Mouth Opening (MMO);Adverse event;Serum GFAP and S100B levels;

Countries

China

Contacts

Public ContactZhang Shilei

Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine

leinnymd@hotmail.com+86 21 23271699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026