Malignant tumor of femur
Conditions
Interventions
Test group:Performing femoral defect filling surgery using 3D printed prosthesis for femoral defect
Sponsors
Department of Orthopedics, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
13 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Before surgery, the subject or guardian is willing and able to sign the informed consent form; (2) Patients aged 13~75 (including 13 and 75 years old), gender is not limited; (3) Patients with segmental bone defects in the femoral region who require prosthesis implantation; (4) The patient's expected survival is greater than 6 months; (5) There are no contraindications to routine laboratory tests and examinations before surgery; (6) Good compliance, willing and able to follow up as required.
Exclusion criteria
Exclusion criteria: (1) Obvious local or systemic serious infection, such as osteomyelitis; (2) any psychiatric or neuromuscular and vascular disorder that may result in serious complications during postoperative care; (3) pregnancy; (4) Patients who do not have sufficient soft tissue coverage at the surgical site or are in poor condition; (5) Clear or suspected allergy to metals, polymer materials or foreign bodies used in the product; (6) Patients with severe osteoporosis, osteomalacia or similar decreased bone mineral density, except in cases that the investigator assessed as insufficient to affect the safety and effectiveness of surgery; (7) Systemic or metabolic diseases, except for patients with hypertension, diabetes and other patients who are controlled by drugs within the clinically acceptable range; (8) The patient's general health is poor, such as coronary heart disease, hypertension and other contraindications to conventional general anesthesia surgery, which are not suitable for surgery after evaluation by anesthesiologists; (9) Obesity that causes the implant to fail to fix or the implant itself to be damaged due to excessive load; (10) the patient is unwilling or unable to follow the instructions of postoperative therapy and/or rehabilitation programs; (11) mental illness, substance abuse or alcohol abuse; Patients who are not guaranteed to quit smoking during the healing of the fracture; (12) Long-term use of drugs that affect the healing of bone and soft tissues (such as chemotherapy drugs, corticosteroids, except methylprednisolone); the use of growth factors, long-term use of sedative-hypnotic drugs (for more than 3 months), long-term use of nonsteroidal anti-inflammatory drugs (for more than 3 months); (13) Other conditions that the investigator determines are not suitable for admission (such as: polio sequelae and other conditions that affect the normal implantation of the prosthesis), etc.; (14) The patient is mentally incapable or unable to understand the requirements to participate in the study; (15) non-compliance is expected; (16) other medical conditions that limit participants' participation in the study, fail to follow up or affect the scientific integrity of the study; (17) Those who refuse to sign informed consent; (18) Patients who have not reached the endpoint of clinical trials in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant stability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Common feature rating scale; | — |
Countries
CHINA
Contacts
Public ContactChongqi Tu
Department of Orthopedics, West China Hospital, Sichuan University, 37# Guoxue Road, Chengdu 610041, China.
Outcome results
None listed