OBJECTIVE: To investigate the the safety and effectiveness of implantation of cemented femoral stem versus percutaneous internal fixation with cannulated compression screws in the treatment of osteoporotic femoral neck fracture in elderly patients.

METHODS: A single-center, prospective, randomized controlled, open-label trial will be performed in Qinghai University Affiliated Hospital, Qinghai, China. One hundred patients with avascular necrosis of the femoral head complicated by osteoporotic femoral neck fracture will be randomly assigned to two groups. Group 1 will undergo percutaneous internal fixation with cannulated compression screws (n=50) and group 2 will be implanted with cemented femoral stem (n=50). This study protocol has been approved by the Medical Ethics Committee of Qinghai University Affiliated Hospital in China and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Signed informed consent regarding trial procedure and treatment will be obtained from each patient or their guardians. This trial was registered at ClinicalTrials.gov (NCT02901938).
RESULTS AND CONCLUSION: The primary outcome measure of this study is hip joint function as assessed by Harris hip scores taken at baseline (prior to surgery), 1, 6 and 12 months after surgery. The secondary outcome measure is hip joint pain score on a Visual Analogue Scale at baseline (prior to surgery), 1, 6 and 12 months after surgery. Other outcome measures include the percentage of patients presenting with femoral head collapse, bone non-union, sterile prosthesis loosening or peri-prosthesis infection 6 and 12 months after surgery. These will be used to evaluate the histocompatibility of biomaterial with the host tissue. Randomized controlled studies are scarce on the long-term therapeutic effects of surgery in the treatment of osteoporotic femoral neck fracture in elderly patients presenting with avascular necrosis of the femoral head. This will be the first study to investigate the feasibility of implantation of cemented femoral stem versus percutaneous internal fixation with cannulated compression screws in the treatment of osteoporotic femoral neck fracture complicated by avascular necrosis of the femoral head. It will test from the perspectives of safety and efficacy through a stringent randomized controlled trial based on a 12-month follow-up evaluation. 

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程