Clinical Trial: Safety and Effectiveness of Proximal Femoral Nail Antirotation for the Treatment of Intertrochanteric Femoral Fracture

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

Official Title: Safety and Effectiveness of Proximal Femoral Nail Antirotation for the Treatment of Intertrochanteric Femoral Fracture: Study Protocol for a Prospective Case Series

Brief Summary: Minimally invasive PFNA fixation for the treatment of intertrochanteric femoral fracture will be used in 20 patients within 2 years to objectively validate the safety and effectiveness of PFNA in the treatment of fracture of long tube-like bone.

Detailed Summary:

History and current status of related studies Intertrochanteric femoral fracture frequently occurs in the elderly that is often complicated by different levels of osteoporosis, and mostly belongs to unstable fractures. This disorder is also frequently complicated by various chronic diseases, which make patients have poorer surgical tolerance. Surgical treatment is the widely accepted treatment method of intertrochanteric femoral fracture because it can accelerate the recovery and reduce the complications caused by long-term bed time. Intertrochanteric femoral fracture is unstable and occurs mostly in the elderly, so surgical treatment should meet the requirements including less risk of wound infection, less intraoperative blood loss, great holding potential and strong stability of the implants, which contribute to early hip joint function exercise and facilitate recovery after surgery.

According to the design principle of orthopedic implants, intramedullary and extramedullary fixations are commonly used. Compared to extramedullary fixation, intramedullary fixation places fixators closer to the affected region, produces shorter moment arm of force, better shares the compression forces on the medial cortex of the femoral neck, exhibits higher shear resistance, and provides greater stabilization for complex fractures in the elderly.

Compared to Garmma nail, an AO (Association for Osteosynthesis) proximal femoral nail has an antirotation screw in the proximal end which ensures an elastic fixation of the fracture and reduces the complications such as femoral shaft fractures. Nevertheless, 2 screws should be installed in the femoral neck, which restricts the slippage between the main screw and the compression screw, thus partial loading will be delivered through antirotation screws, leading to occurrence of complications such as
Sponsor: Chaohu Hospital of Anhui Medical University

Current Primary Outcome: Complications [ Time Frame: 6 months after surgery ]

pains on the affected region, wound nonunion, incision infection


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fracture healing [ Time Frame: baseline, at 3 and 6 months after surgery ]
    evaluated by X-ray images
  • Hip joint function [ Time Frame: baseline, at 3 and 6 months after surgery ]
    evaluated by Harris hip scores
  • Patient's quality of life [ Time Frame: baseline, at 3 and 6 months after surgery ]
    evaluated by EuroQol five dimensions questionnaire (EQ-5D)
  • Barthel Index of Activities of Daily Living (Barthel ADL Index) [ Time Frame: baseline, at 3 and 6 months after surgery ]
    Barthel ADL Index is used to evaluate patient's activities of daily living.


Original Secondary Outcome: Same as current

Information By: Chaohu Hospital of Anhui Medical University

Dates:
Date Received: August 18, 2016
Date Started: January 2015
Date Completion: December 2016
Last Updated: August 23, 2016
Last Verified: August 2016