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Construction and clinical transformation of individualized functional reconstruction treatment system for pelvic tumors

Construction and clinical transformation of individualized functional reconstruction treatment system for pelvic tumors

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037020
Enrollment
Unknown
Registered
2020-08-26
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-28

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

Conditions

Pelvic Defect

Interventions

Trail Group:Tantalum coated 3D printed hemipelvic prosthesis
Control Group: 3D printed hemipelvic prosthesis

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with complex bone defects caused by tumor and inflammatory osteolysis; 2. Chinese male / female citizens over 16 years old and under 85 years old; 3. Platelets above 50000, fasting blood glucose not higher than 10.0, white blood cells no less than 4.0 x 10^9 / L, with good nutritional status; 4. No implant contraindications; 5. Voluntary participation and informed consent.

Exclusion criteria

Exclusion criteria: 1. Any active systemic and local infection; 2. Poor general condition, severe malnutrition or cachexia, and poor blood glucose control; 3. Multiple bone metastases have occurred in primary bone tumors; 4. Multiple bone metastases, or the primary focus is too serious to be cured; 5. The expected survival time is not more than two years; 6. Other clinical verifications within 3 months; 7. Failure to follow up on schedule; 8. The new technology used in this experiment can not be accepted.

Design outcomes

Primary

MeasureTime frame
Evaluation of bone ingrowth at interface by thin slice CT;

Secondary

MeasureTime frame
Related symptoms caused by bone defect;The position of prosthesis was evaluated by X-ray;(MSTS) - 93 lower extremity function score;

Countries

China

Contacts

Public ContactHao Yongqiang

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

Hao_yongqiang@hotmail.com+86 13501969828

Outcome results

None listed

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