It is applicable to long bone diseases such as bone tumors, traumatic bone defects, nonunion of fractures, and severe bone infections.
Conditions
Interventions
Single-arm study:Implant long bone prostheses into subjects who meet the enrollment criteria.
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Subjects with long bone shaft defects greater than 4cm due to bone tumors, traumatic bone defects, severe bone infection post-resection (with infection well-controlled), congenital or acquired long bone pseudoarthrosis, or non-union of long bone fractures, requiring stability reconstruction; 2.Individuals who have not participated in any other clinical trials within the past 3 months; 3.Those who fully understand the benefits and risks of customized medical devices, are still willing to participate, and have signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Any subject unwilling to comply with postoperative instructions or medical advice; 2.Any subject with insufficient soft tissue coverage at the surgical site; 3.Subjects with congenital or acquired increased bone fragility, or those with severe calcification disorders; 4.Subjects with infections involving the surgical site or with local inflammatory manifestations that are not effectively controlled; 5.Psychiatric diseases; 6.Morbid obesity (Body Mass Index [BMI] = 40); 7.Pregnancy; 8.Aggressive arthritis, osteomalacia, osteolysis, and severe osteoporosis (T-score < -3.5). Osteolysis and osteoporosis are relative contraindications and may potentially affect the outcome of surgical treatment; 9.Subjects suspected or proven to be allergic or intolerant to metallic materials; 10.Any disease that may hinder the surgical benefits of the implant; 11.Any other subjects deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The stability of the prosthesis; | — |
Secondary
| Measure | Time frame |
|---|---|
| The score of Musculoskeletal Tumor Society (MSTS); | — |
Countries
China
Contacts
Public ContactSun Wei
Shanghai General Hospital
Outcome results
None listed