None
Conditions
Interventions
Observation group for treatment of infectious nonunion of different bone segments:None
Sponsors
Yuebei People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Medical history (persistent pain after fracture, local redness, swelling or sinus tract formation); 2.Imaging findings (X-ray shows no callus formation at the fracture site and a clear fracture line, CT reveals sclerosis or pseudoarthrosis at the fracture site); 3.Microbiological testing (cultivation of lesion secretions or intraoperative tissue biopsy to identify the causative pathogen); 4.The infected sites are the humerus of the upper limb, the tibia or femur of the lower limb (excluding special sites such as the spine and pelvis); 5.Age 18-70 years, able to tolerate the second stage surgery and 12-month postoperative follow-up; 6.The patient and their family fully understand the research protocol, sign the informed consent form, and commit to cooperating in completing all examinations and follow-ups.
Exclusion criteria
Exclusion criteria: 1.Impaired function of vital organs: cardiac function classification = III, liver and kidney failure (Child-Pugh C grade, serum creatinine > 200 µmol/L), coagulation dysfunction (INR > 1.5 or APTT > 60 seconds); 2.Allergic to recombinant human BMP-2, calcium phosphate artificial bone, vancomycin/meropenem (antibiotics used in antibiotic-loaded artificial bone); 3.Psychiatric disorders (unable to comply with follow-up), bone defects > 6cm (exceeding the scope of mixed bone grafting repair), incomplete clinical data; 4.Combine active tuberculosis, malignant tumors, and immunodeficiency diseases (such as HIV infection);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone healing rate;Infection control rate;Material adverse reaction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone Metabolism Indicators;Clinical Functional Scoring;Complication rate;Bone healing time; | — |
Countries
China
Contacts
Public ContactZhou Longze
Yuebei People’s Hospital
Outcome results
None listed