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Internal Fixation or Joint Replacement Therapy for Aged Hip Fracture Patients

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ClinicalTrials.gov Identifier: NCT03407131
Recruitment Status : Not yet recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
baoguojiang, 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.

Condition or disease Intervention/treatment Phase
Intertrochanteric Fractures Procedure: Joint replacement surgery Procedure: Intramedullary nail fixation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Bleeding related index [ Time Frame: Three days after the operation ]
    Postoperative drainage volume and bleeding volume during operation(Unit: ml)


Secondary Outcome Measures :
  1. Joint rehabilitation index [ Time Frame: Three months after the operation ]
    Early loading time

  2. Complication rate [ Time Frame: Three monthes after the operation ]
    The incidence of postoperative lung infection, urinary tract infection, bedsore and mortality

  3. Functional rehabilitation index [ Time Frame: Three months after the operation ]
    Harris Scores of the two groups

  4. Surgical related index [ Time Frame: Three days after the operation ]
    operation time of the two groups(Unit: minutes)



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407131


Locations
China
Peking University People's Hospital
Peking, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
Investigators
Study Director: Baoguo Jiang, Doctor Peking University People's Hospital

Responsible Party: 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
ClinicalTrials.gov Identifier: NCT03407131     History of Changes
Other Study ID Numbers: PUPH20171228
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by baoguojiang, Peking University People's Hospital:
Intertrochanteric fracture, Medical complications

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries