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
| Registry | NCT03407131 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 100 (Estimated) |
| Sponsor | Peking University People's Hospital (Other) |
| Conditions | Intertrochanteric Fractures |
| Interventions | Joint replacement surgery, Intramedullary nail fixation (Procedure) |
| Dates | start 2018-02-01 (estimated), primary completion 2018-12-31 (estimated), completion 2019-03-01 (estimated), first posted 2018-01-23, last updated 2018-01-23 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Intertrochanteric Fractures All trials of Joint replacement surgery All trials of Intramedullary nail fixation
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Joint replacement | Experimental | Procedure: Joint replacement surgery | 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. |
| Intramedullary nail fixation | Active comparator | Procedure: Intramedullary nail fixation | 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. |
Sex: All, ages: 75 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Peking University People's Hospital | Beijing | China |