NCT03407131

Internal Fixation or Joint Replacement Therapy for Aged Hip Fracture Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intertrochanteric Fractures

Interventions

Type	Name	Description
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.
PROCEDURE	Intramedullary nail fixation	Internal fixation surgery is the stable fixation of fracture, which provides the condition for the restoration of joint function.

Timeline

• Start date: 2018-02-01
• Primary completion: 2018-12-31
• Completion: 2019-03-01
• First posted: 2018-01-23
• Last updated: 2018-01-23

Locations

1 site across 1 country: China