Femoral shaft nonunion
Conditions
Interventions
control group:traditional LCP
experimental group:MDC-LP
Sponsors
General Hospital of Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged>18 years; 2. Femoral shaft nonunion after intramedullary nailing; 3. Augmentation plate adopted as the revision surgery;The additional plates used are multi-dimensional cross-locking plates (MDC-LP) or conventional straight LCP (3.5mm and 4.5mm); 4. Subjects must be able to talk normally, understand the questions on the subject's subjective questionnaire, and provide feedback in appropriate language;
Exclusion criteria
Exclusion criteria: 1. pregnant or breastfeeding woman; 2. Less than 6 months after intramedullary nail fixation for femoral shaft fractures; 3. The patient was accompanied by non-union of fractures in other parts of the limbs, and surgical treatment was also needed simultaneously or successively; 4. Nonunion after pathological fractures (such as primary or metastatic tumors); 5. The affected limb has limb deficiency from knee; 6. Infected nonunion of the affected limb itself or other parts of the limb; 7. The adjacent joint of the affected side has undergone joint replacement, which may affect the selection of additional plates (such as the long plates required to cross the joint prosthesis and the original intramedullary nail, etc.); 8. Segmental bone defect >=6cm; 9. Use >=2 additional plates for revision surgery; 10. Patients with certain medical diseases, such as diabetes, metabolic bone disease, sequelae of poliomyelitis, and secondary severe osteoporosis (such as hyperparathyroidism); 11. Patients have anesthesia and surgical contraindications; 12. The patient is allergic to the implant components; 13. The patient is currently receiving chemotherapy or radiotherapy, systemic application of corticosteroids or growth factors, or long-term use of sedatives and hypnotics (continuous use for more than 3 months) or non-steroidal anti-inflammatory drugs (continuous use for more than 3 months); 14. Patients may have poor compliance and be judged inappropriate for inclusion by the investigator (e.g. excessive daily drinking or smoking, drug use); 15. The patient has participated in other clinical trials in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fracture healing rate;fracutre healing time (mm); | — |
Secondary
| Measure | Time frame |
|---|---|
| length of incision;length of plate;number of screws in plate;number of cortices fixation by screw;SF-36;Lower extremity functional scale;Pain VAS;Lysholm knee functional scale; | — |
Countries
China
Contacts
Public ContactHua Chen
General Hospital of Chinese People's Liberation Army
Outcome results
None listed