Intertrochanteric Fractures
Conditions
Keywords
Intertrochanteric fracture, Medical complications
Brief summary
To evaluate the efficacy and safety of internal fixation or arthroplasty for hip fracture patients over 75 years of age with multiple medical complications through the operation time, intraoperative bleeding, time to start weight bearing activities and other indicators.
Detailed description
Patients will be enrolled from five study centers, each center will be free with regard to surgical indications and postoperative prescription. The unstable fractures were A2 and A3 (31 A2.2 and 3, and 31 A3.3) according to the AO classification. The investigators will use a prospective randomized approach to determine the treatment procedure for patients. The patients undergoing arthroplasty will be regarded as the experimental group and the patients who accept the intramedullary nail fixation will be regarded as the positive control group. All patients will receive consistent anticoagulant, analgesic and other therapeutic measures in the perioperative period except for the different surgical methods. The two groups will be compared in age, sex, pre-fracture place of residence, fracture type and preoperative comorbidity. The investigators will evaluate the effect and safety of the two types of operations by comparing the surgical related data, complication incidence and functional rehabilitation.
Interventions
PROCEDUREJoint replacement surgery
Joint replacement surgery is to replace the original joint function, so that the patient can recover the joint function as soon as possible.
PROCEDUREIntramedullary nail fixation
Internal fixation surgery is the stable fixation of fracture, which provides the condition for the restoration of joint function.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Intertrochanteric fractures of the femur need surgery * Male and female, age more than 75 years old * Combined with more than one medical complication, including hypertension, cerebral infarction, respiratory failure, renal insufficiency, coronary heart disease, diabetes, heart failure, pulmonary infection, heart rate, water and electrolyte disorders * The patient is still able to tolerate surgery through the anaesthesia and related department assessment * Signed written informed consent
Exclusion criteria
* No complications associated with internal medicine * Mild fracture displacement and conservative treatment required * Multiple trauma involving more than one organ system * Known to have progressive malignant neoplasms * It is not possible for the subjects to follow the test scheme, such as uncooperative attitudes, inability to return to the research centre for follow-up visits and inability to complete the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding related index | Three days after the operation | Postoperative drainage volume and bleeding volume during operation（Unit: ml） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Joint rehabilitation index | Three months after the operation | Early loading time |
| Complication rate | Three monthes after the operation | The incidence of postoperative lung infection, urinary tract infection, bedsore and mortality |
| Functional rehabilitation index | Three months after the operation | Harris Scores of the two groups |
| Surgical related index | Three days after the operation | operation time of the two groups（Unit: minutes） |
Countries
China
Outcome results
None listed