Back to results

Internal Fixation or Joint Replacement Therapy for Aged Hip Fracture Patients

Primary Purpose

Intertrochanteric Fractures

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Joint replacement surgery

Intramedullary nail fixation

About this trial

This is an interventional treatment trial for Intertrochanteric Fractures focused on measuring Intertrochanteric fracture, Medical complications

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

Peking University People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Joint replacement

Intramedullary nail fixation

Arm 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.

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.

Outcomes

Primary Outcome Measures

Bleeding related index

Postoperative drainage volume and bleeding volume during operation（Unit: ml）

Secondary Outcome Measures

Joint rehabilitation index

Early loading time

Complication rate

The incidence of postoperative lung infection, urinary tract infection, bedsore and mortality

Functional rehabilitation index

Harris Scores of the two groups

Surgical related index

operation time of the two groups（Unit: minutes）

Full Information

NCT ID

NCT03407131

First Posted

January 11, 2018

Last Updated

January 21, 2018

Sponsor

Peking University People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03407131

Brief Title

Internal Fixation or Joint Replacement Therapy for Aged Hip Fracture Patients

Official Title

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

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2018 (Anticipated)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

March 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intertrochanteric Fractures

Keywords

Intertrochanteric fracture, Medical complications

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Joint replacement

Arm Type

Experimental

Arm Description

Arm Title

Intramedullary nail fixation

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Joint replacement surgery

Intervention Description

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

Intervention Name(s)

Intramedullary nail fixation

Intervention Description

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

Primary Outcome Measure Information:

Title

Bleeding related index

Description

Postoperative drainage volume and bleeding volume during operation（Unit: ml）

Time Frame

Three days after the operation

Secondary Outcome Measure Information:

Title

Joint rehabilitation index

Description

Early loading time

Time Frame

Three months after the operation

Title

Complication rate

Description

The incidence of postoperative lung infection, urinary tract infection, bedsore and mortality

Time Frame

Three monthes after the operation

Title

Functional rehabilitation index

Description

Harris Scores of the two groups

Time Frame

Three months after the operation

Title

Surgical related index

Description

operation time of the two groups（Unit: minutes）

Time Frame

Three days after the operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Baoguo Jiang, Doctor

Organizational Affiliation

Peking University People's Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Peking University People's Hospital

City

Peking

ZIP/Postal Code

100044

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Internal Fixation or Joint Replacement Therapy for Aged Hip Fracture Patients

We'll reach out to this number within 24 hrs