Internal Fixation or Joint Replacement Therapy for Aged Hip Fracture Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Intertrochanteric Fractures
• Intervention / Treatment: Procedure: Joint replacement surgery; Procedure: Intramedullary nail fixation

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Peking, China, 100044
    • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Active Comparator: 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.	Procedure: Intramedullary nail fixation; Internal fixation surgery is the stable fixation of fracture, which provides the condition for the restoration of joint function.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Study Director: Baoguo Jiang, Doctor, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: January 21, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 21, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Intertrochanteric fracture, Medical complications
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: PUPH20171228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No