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Application of combined skull base and temporomandibular joint prosthesis in the reconstruction of skull base and joint defects

Application of combined skull base and temporomandibular joint prosthesis in the reconstruction of skull base and joint defects

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093073
Enrollment
Unknown
Registered
2024-11-28
Start date
2020-10-07
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Skull base-joint defect

Interventions

experimental group:Combined skull base-TMJ prosthesis

Sponsors

Shanghai Ninth Peoples’ Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) The subjects were over 20 years old (inclusive), regardless of gender; 2) lesions causing skull base-joint defects; 3) those who did not participate in other clinical verification within 3 months; 4) no acute infectious disease, psychosis, or systemic disease; 5) Voluntary subjects and signed informed consent.

Exclusion criteria

Exclusion criteria: 1) patients allergic to titanium implants; 2) patients with acute or severe infection or acute exacerbation of chronic infection; 3) patients with extensive soft tissue defects caused by surgery and insufficient soft tissue coverage of the wound after surgery; 4) patients with radiation osteomyelitis, acute and chronic osteomyelitis, osteoporosis; 5) patients with uncontrolled primary diseases of important organs such as heart, lung, brain and kidney; 6) patients with mental illness; 7) pregnant and lactating women; 8) patients unable to cooperate with treatment; 9) patients with advanced malignant tumors, distant metastasis or tumor recurrence; 10) critically ill patients, and it is difficult to make a definite evaluation of the effectiveness and safety of the prosthesis.

Design outcomes

Primary

MeasureTime frame
QOL score;

Secondary

MeasureTime frame
Pain;Maximum mouth opening;Function;Movement of the jaw;The osseointegration of the prosthesis;Maxillofacial morphology;Lateral movement;

Countries

China

Contacts

Public ContactYang Chi

Ninth People's Hospital Affiliated to Shanghai JiaoTong University School of Medicine

yangchi63@hotmail.com+86 138 1871 2506

Outcome results

None listed

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