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STUDY PROTOCOL
Year : 2016  |  Volume : 1  |  Issue : 3  |  Page : 90-99

Safety and effectiveness of proximal femoral nail antirotation for the treatment of intertrochanteric femoral fracture: study protocol for a prospective case series


Department of Orthopedics, Chaohu Hospital of Anhui Medical University, Chaohu, Anhui Province, China

Correspondence Address:
Jun-jie Xu
Department of Orthopedics, Chaohu Hospital of Anhui Medical University, Chaohu, Anhui Province
China
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Source of Support: This study was supported by New Technology and New Business Project Fund of Chaohu Hospital of Anhui Medical University of China., Conflict of Interest: None


DOI: 10.4103/2468-5674.189505

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Background: The root cause of intertrochanteric femoral fracture in elderly patients is osteoporosis manifested by reduced bone strength, decreased bone mineral density, and subsequently decreased anchoring between the internal fixator and bone. This is also a major cause of ineffective internal fixation and leads to surgical failure. Because of the special anatomical structure and biomechanical requirements of the proximal femur, internal fixation must have two basic functions, to prevent inversion and rotation of the proximal fractured femur. Reducing the incidence of coxa vara is also one of the treatment objectives. Methods/Design: This is a single-center, prospective, self-controlled case series. The objective of this study is to validate the safety and effectiveness of minimally invasive proximal femoral nail antirotation (PFNA) in the treatment of intertrochanteric femoral fracture. Twenty patients with intertrochanteric femoral fracture scheduled to undergo PFNA implantation will be recruited from the Department of Orthopedics, Chaohu Hospital of Anhui Medical University, China. The primary outcome measure of this study is the percentage of patients having PFNA implantation-related safety problems manifested as pain in the affected region, wound nonunion, incisional infection, and gross findings observed at the time of nail removal, including inflammatory reaction, tissue proliferation, and the appearance of a fibrous capsule wall 3 and 6 months after PFNA implantation. The secondary outcome measures are operative time, intraoperative blood loss, duration of intraoperative fluoroscopy, patients' quality of life evaluated by the EuroQol five-dimension questionnaire and the Barthel Index of Activities of Daily Living, fracture healing examined by X-ray images, and hip joint function evaluated by Harris hip scores 3 and 6 months after PFNA implantation. Discussion: The currently reported clinical studies on PFNA for the treatment of intertrochanteric femoral fracture are mainly case series, a few of which are retrospective, randomized, controlled trials. Here, we will perform a normalized prospective case series to validate the safety and effectiveness of PFNA in the treatment of intertrochanteric femoral fracture. Trial registration: ClinicalTrial.gov identifier: NCT02880501; registered on 18 August 2016. Ethics: This trial has been approved by Ethics Committee, Chaohu Hospital of Anhui Medical University, China and will be performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Signed informed consent will be obtained from the patients or their relatives.


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