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The multicenter, randomized, open and positive control study to realize the individualized limb-salvage reconstruction of the pelvic tumors based on 3D printing technology

The multicenter, randomized, open and positive control study to realize the individualized limb-salvage reconstruction of the pelvic tumors based on 3D printing technology

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16010294
Enrollment
Unknown
Registered
2016-12-29
Start date
2016-12-26
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

pelvic tumors

Interventions

trial group:using 3D printing prosthesis to reconstruct the limb
control group:using traditional half pelvic prosthesis to reconstruct the limb

Sponsors

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

Eligibility

Sex/Gender
All
Age
16 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. 16 years of age or older, and our citizens under the age of 85 years; 2. platelets above 50000, blood sugar is not higher than 10.0, white blood cells no less than 4.0 x10^9/L, good nutritional status; 3. hepatitis a, hepatitis b, hepatitis c, HIV/AIDS, tuberculosis and other infectious diseases are not in the activity stage; 4. primary pelvic bone tumors without metastasis, or only single metastases; 5. single pelvic metastase , and the primary focal disease can be effectively controlled. 6. involving the hip malignant tumor limb-salvage excision need function reconstruction; 7. no implant contraindication; 8. postoperative survival above 2 years or more; 9. do not attend any clinical validation within three months; 10. agreed to participate in the test, understand and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. any active systemic and local infection; 2. poor general condition, severe malnutrition or cachexia, poor blood sugar control. 3. multi-bone metastases; 4. multiple bone metastases, or primary focal disease too severe to be effectively treated; 5. defects of bone and soft tissue involvement heavily influence the implant stability; 6. allergic to the material; 7. estimated lifetime is not more than two years; 8. not timely follow-up, or for other reasons can't cooperate with researchers; 9. can not accepte the new technology.

Design outcomes

Primary

MeasureTime frame
MSTS score;

Secondary

MeasureTime frame
surgery time;Intraoperative blood transfusion volume;Intraoperative and postoperative complications;remission of tumor symptoms after surgery;Imaging findings;

Countries

China

Contacts

Public ContactYongqiang Hao

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

hyq_9hospital@hotmail.com+86 13501969828

Outcome results

None listed

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