Clinical Trial: Feasibility of Implantation of Cemented Femoral Stem for Osteoporotic Femoral Neck Fracture in Elderly Patients

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Feasibility of Implantation of Cemented Femoral Stem in the Treatment of Osteoporotic Femoral Neck Fracture in Elderly Patients: a Randomized Controlled Trial

Brief Summary: This study will investigate the effects of implantation of cemented femoral stem versus percutanous internal fixation with cannulated compression screws on hip joint function recovery, pains, femoral head collapse and sterile prosthesis loosening, peri-prosthesis infection, and the histocompatibility of prosthesis material with host tissue in the elderly patients with osteoporotic fracture of proximal femoral neck complicated by avascular necrosis of the femoral head, which will provide scientific evidence for selecting surgical methods and internal fixation/artificial prosthesis material for osteoporotic fracture of proximal femoral neck in the elderly patients.

Detailed Summary:

History and current related studies Femoral neck fracture is a common fracture that accounts for 3.58% of all fractures, easily occurs in the elderly with a gradually increased incidence, predisposes to bone nonunion, and greatly influences patient's mental and physical health. Bone nonunion easily occurs after femoral neck fracture because of anatomic position, biomechanical property and local blood supply. The objective of treatment of femoral neck fracture in patients aged 65 years and above is to rapidly restore lower limb function and reduce the complications caused by long term bed rest. Surgery for treatment of femoral neck fracture in the elderly is a satisfactory option because it not only contributes to recovery of joint function, but also decreases the incidence of complications. Several concerns are addressed during the process from design of internal fixation equipment to selection of clinical treatment protocol including minimizing surgical trauma, shortening length of surgery, and promoting functional recovery of hip joint. Osteoporosis is generally considered the most difficult problem to be solved after surgery for femoral neck fracture in the elderly patients. The key points of internal fixation for femoral neck fracture are to optimize bone space and strengthen fractured bone trabecula, yielding strong fixation biomechanically. Percutaneous internal fixation with cannulated compression screws has become a preferred treatment method of osteoporotic femoral neck fracture in elderly patients because of its short length of surgery and less blood loss, but insufficient holding power of used screws in the femoral neck cannot lead to strong fixation. Therefore, joint prosthesis is recommended for repair of femoral neck fracture in elderly patients. Implantation of femoral stem for treatment of early proximal femoral neck fracture has achieved confirmed clinical efficacy, but the long-term therapeutic effects
Sponsor: Qinghai University

Current Primary Outcome: Changes of Harris hip scores [ Time Frame: at baseline, 1, 6 and 12 months after surgery ]

To evaluate the recovery of hip joint function from the domains covering pain, function, absence of deformity, and range of motion, with higher scores indicating better hip joint function. Hip joint function is scored as follows: ≥ 90 is excellent, 80-89 very good, 70-79 good, and < 70 poor.


Original Primary Outcome: Same as current

Current Secondary Outcome: Changes of VAS scores [ Time Frame: at baseline, 1, 6 and 12 months after surgery ]

To evaluate the severity of pain and ranges from 0-10, with higher scores indicating more severe pain. A score of 0 represents no pain, scores > 0 and ≤ 3 represent mild pain, scores > 3 and ≤ 6 moderate pain, and scores > 6 and ≤ 10 severe pain.


Original Secondary Outcome: Same as current

Information By: Qinghai University

Dates:
Date Received: September 12, 2016
Date Started: January 2016
Date Completion: December 2018
Last Updated: September 14, 2016
Last Verified: September 2016