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Internal Fixation or Joint Replacement Therapy for Aged Hip Fracture Patients

NCT03407131 — Not applicable, Unknown, 100 participants, Peking University People's Hospital

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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

RegistryNCT03407131
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment100 (Estimated)
SponsorPeking University People's Hospital (Other)
ConditionsIntertrochanteric Fractures
InterventionsJoint replacement surgery, Intramedullary nail fixation (Procedure)
Datesstart 2018-02-01 (estimated), primary completion 2018-12-31 (estimated), completion 2019-03-01 (estimated), first posted 2018-01-23, last updated 2018-01-23
Locations1 site in China

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Joint replacementExperimentalProcedure: Joint replacement surgeryIntertrochanteric 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.
Intramedullary nail fixationActive comparatorProcedure: Intramedullary nail fixationIntertrochanteric 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.
  • Joint replacement surgery (Procedure): Joint replacement surgery is to replace the original joint function, so that the patient can recover the joint function as soon as possible.
  • Intramedullary nail fixation (Procedure): Internal fixation surgery is the stable fixation of fracture, which provides the condition for the restoration of joint function.

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 75 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Peking University People's HospitalBeijingChina

+Investigators

My Notes