Internal Fixation or Joint Replacement Therapy for Aged Hip Fracture Patients

Not Applicable

• Conditions: Intertrochanteric Fractures
• Interventions: Procedure: Intramedullary nail fixation; Procedure: Joint replacement surgery

• Registration Number: NCT03407131
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Status Verified: 2018-01
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-21
• Last Update Submitted: 2018-01-21
• Study First Posted: 2018-01-23
• Last Update Posted: 2018-01-23
• Study Start: 2018-02-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intramedullary nail fixation	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.
Joint replacement	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.

Primary Outcome Measures

Name	Time	Method
Bleeding related index	Three days after the operation	Postoperative drainage volume and bleeding volume during operation（Unit: ml）

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Peking, China