An interventional study of Joint replacement surgery and Intramedullary nail fixation in Intertrochanteric Fractures, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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
Joint replacement surgery is to replace the original joint function, so that the patient can recover the joint function as soon as possible.
Internal fixation surgery is the stable fixation of fracture, which provides the condition for the restoration of joint function.
Bleeding related index
Postoperative drainage volume and bleeding volume during operation（Unit: ml）
Time frame: Three days after the operation
Joint rehabilitation index
Early loading time
Time frame: Three months after the operation
Complication rate
The incidence of postoperative lung infection, urinary tract infection, bedsore and mortality
Time frame: Three monthes after the operation
Functional rehabilitation index
Harris Scores of the two groups
Time frame: Three months after the operation
Surgical related index
operation time of the two groups（Unit: minutes）
Time frame: Three days after the operation
Plan to share: Undecided
No publications or documents are linked to this record.
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Peking University People's Hospital