Internal Fixation or Joint Replacement Therapy for Aged Hip Fracture Patients

NCT ID: NCT03407131

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-03-01

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.

Conditions

Intertrochanteric Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Joint replacement

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.

Group Type: EXPERIMENTAL

Joint replacement surgery

Intervention Type: PROCEDURE

Joint replacement surgery is to replace the original joint function, so that the patient can recover the joint function as soon as possible.

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.

Group Type: ACTIVE_COMPARATOR

Intramedullary nail fixation

Intervention Type: PROCEDURE

Internal fixation surgery is the stable fixation of fracture, which provides the condition for the restoration of joint function.

Interventions

Joint 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.

Intervention Type: PROCEDURE

Intramedullary nail fixation

Internal fixation surgery is the stable fixation of fracture, which provides the condition for the restoration of joint function.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

baoguojiang

Dean of Peking University People's Hospital, Director of department of orthopaedic surgery of Peking University, Chairman of China trauma rescue&treatment association

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Baoguo Jiang, Doctor

Role: STUDY_DIRECTOR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, , China

Countries

China

Other Identifiers

PUPH20171228

Identifier Type: -

Identifier Source: org_study_id