Internal Fixation or Joint Replacement Therapy for Aged Hip Fracture Patients

Overview

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 Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 31, 2018

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.

Interventions

  • 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.
  • Procedure: Intramedullary nail fixation
    • Internal fixation surgery is the stable fixation of fracture, which provides the condition for the restoration of joint function.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 75 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking University People’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: baoguojiang, Dean of Peking University People’s Hospital, Director of department of orthopaedic surgery of Peking University, Chairman of China trauma rescue&treatment association – Peking University People’s Hospital
  • Overall Official(s)
    • Baoguo Jiang, Doctor, Study Director, Peking University People’s Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.