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Clinical trial of 3D printing technology in the operation of bone and joint reconstruction

Clinical trial of 3D printing technology in the operation of bone and joint reconstruction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16009327
Enrollment
Unknown
Registered
2016-10-08
Start date
2016-10-01
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

Bone defect and osteoarthritis

Interventions

Experimental Group:3D printing of bone and joint implants
Control Group:Traditional artificial bone and joint implant

Sponsors

Shanghai Ninth Peoples's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years; 2. there are difficult to control and significantly affect the function of limb joint pain or limb bone and joint disease damage affect the joint stability or neurological symptoms of progressive increase; 3. hepatitis A, hepatitis B, hepatitis C, AIDS and other infectious diseases inactive; 4. platelets more than 50,000, blood sugar is not higher than 10.0mmol / l, white blood cells not less than 4.0×10^9/l, good nutritional status; 5. no implant contraindication; 6. expected survival of more than 5 years after surgery; 7. agreed to participate in this trial, understand and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. the body or other parts are active infection; 2. the general situation is poor, such as poor blood sugar control, there are severe malnutrition or cachexia; 3. the general condition or associated with disease leading to intolerance replacement surgery 4. there is neurogenic joint disease, severe osteoporosis or severe bone tumor metastasis 5. local skin, soft tissue and blood supply is poor, may lead to difficulty in postoperative incision closure or local tissue necrosis; 6. peri-articular muscle paralysis, it is difficult to maintain postoperative joint stability or difficult to complete joint active activities; 7. bone defects and soft tissue involvement in a wide range of fixed impact on the stability of the implant; 8. there can not be rebuilt on the line anomaly; 9. there have been six months of cardiovascular and cerebrovascular accident; 10. the materials used allergy; 11. before the start of this study has participated in three months of other clinical trials; 12. can not be scheduled for follow-up or for other reasons can not cooperate with the researchers.

Design outcomes

Primary

MeasureTime frame
Joint function score;

Secondary

MeasureTime frame
Quality of life scale;

Countries

China

Contacts

Public ContactJinwu Wang

Shanghai Ninth Peoples's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

jinwu_wang@qq.com+86 13301773680

Outcome results

None listed

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