NCT03407131

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

January 11, 2018

Last Update Submit

January 21, 2018

Conditions

Intertrochanteric Fractures

Keywords

Intertrochanteric fracture, Medical complications

Outcome Measures

Primary Outcomes (1)

  • Bleeding related index

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

    Three days after the operation

Secondary Outcomes (4)

  • Joint rehabilitation index

    Three months after the operation

  • Complication rate

    Three monthes after the operation

  • Functional rehabilitation index

    Three months after the operation

  • Surgical related index

    Three days after the operation

Study Arms (2)

Joint replacement

EXPERIMENTAL

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

Intramedullary nail fixation

ACTIVE COMPARATOR

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

Interventions

Joint replacement surgeryPROCEDURE

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

Joint replacement
Intramedullary nail fixationPROCEDURE

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

Intramedullary nail fixation

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

Arthroplasty

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Baoguo Jiang, Doctor

    Peking University People's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean of Peking University People's Hospital, Director of department of orthopaedic surgery of Peking University, Chairman of China trauma rescue&treatment association

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 23, 2018

Study Start

February 1, 2018

Primary Completion

December 31, 2018

Study Completion

March 1, 2019

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

CN(1)