Internal Fixation or Joint Replacement Therapy for Aged Hip Fracture Patients

Peking University

Status: Unknown

Conditions: Intertrochanteric Fractures

Treatments: Procedure: Joint replacement surgery; Procedure: Intramedullary nail fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT03407131

PUPH20171228

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Joint replacement

Experimental group

Description:

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.

Treatment:

Procedure: Joint replacement surgery

Intramedullary nail fixation

Active Comparator group

Description:

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.

Treatment:

Procedure: Intramedullary nail fixation