Internal Fixation or Joint Replacement Therapy for Aged Hip Fracture Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Internal Fixation or Joint Replacement Therapy for Hip Fracture Patients Over 75 Years Old Combined With Multiple Internal Medicine Complications: a Prospective, Multicenter, Randomized Controlled Trial

Conditions
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Intertrochanteric Fractures

Intervention / Treatment
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* Procedure: Joint replacement surgery
* Procedure: Intramedullary nail fixation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Joint replacement<br>Intertrochanteric fracture patients were treated with joint replacement surgery.The postoperative drainage volume, blood transfusion volume, intraoperative blood loss, operative time, early weight bearing time will be recorded, and postoperative pulmonary infection, urinary tract infection, bedsore incidence and postoperative functional rehabilitation will be observed. | Procedure: Joint replacement surgery<br>* Joint replacement surgery is to replace the original joint function, so that the patient can recover the joint function as soon as possible.<br>|
| Active Comparator: Intramedullary nail fixation<br>Intertrochanteric fracture patients were treated with intramedullary nail fixation surgery.The postoperative drainage volume, blood transfusion volume, intraoperative blood loss, operative time, early weight bearing time will be recorded, and postoperative pulmonary infection, urinary tract infection, bedsore incidence and postoperative functional rehabilitation will be observed. | Procedure: Intramedullary nail fixation<br>* Internal fixation surgery is the stable fixation of fracture, which provides the condition for the restoration of joint function.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding related index | Postoperative drainage volume and bleeding volume during operation（Unit: ml） | Three days after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint rehabilitation index | Early loading time | Three months after the operation | 
| Complication rate | The incidence of postoperative lung infection, urinary tract infection, bedsore and mortality | Three monthes after the operation | 
| Functional rehabilitation index | Harris Scores of the two groups | Three months after the operation | 
| Surgical related index | operation time of the two groups（Unit: minutes） | Three days after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intertrochanteric fracture, Medical complications