20 34 2016 08 19 Chinese Journal of Tissue Engineering Research August 19, 2016 Vol.20, No.34 ( 810001). [J]. 2016 20(34):5163-5168. DOI: 10.3969/j.issn.2095-4344.2016.34.023 ORCID: 0000-0003-1929-7900( ) 1 6 12 50 Harris 100 50 X 2 cm 1 1 1976 2015 810001 :R318 :B :2095-4344 (2016)34-05163-06 2016-05-20 100 2 50 1 12 Harris 1 6 Harris 1 6 12 6 12 6 12 (QHY1016B) ISSN 2095-4344 CN 21-1581/R CODEN: ZLKHAH 5163
. Zhang He-ling, Master, Attending physician, Department of Orthopedic Trauma, Qinghai University Affiliated Hospital, Xining 810001, Qinghai Province, China Corresponding author: Zhang He-ling, Department of Orthopedic Trauma, Qinghai University Affiliated Hospital, Xining 810001, Qinghai Province, China Porous tantalum rod implantation improves the hip joint function of patients with avascular necrosis of the femoral head after femoral neck fracture surgery: study protocol for a randomized controlled trial Zhang He-ling, Deng Ming-hao, Yang Jian-cheng (Department of Orthopedic Trauma, Qinghai University Affiliated Hospital, Xining 810001, Qinghai Province, China) Abstract BACKGROUND: After femoral neck fracture, avascular necrosis of the femoral head occurs because of insufficient blood supply to the femoral head, resulting in increased difficulty in treatment, and greatly influencing the recovery of hip joint function. Core decompression and bone grafting is a common treatment method of avascular necrosis of the femoral head. A porous tantalum rod is a bone trabecula-like metal implant that is used to support weight-bearing area of necrotic bone, prevent further collapse of the necrotic area, and thereby exhibits favorable effects in the early treatment of avascular necrosis of the femoral head. Few randomized controlled studies are reported on porous tantalum rod implantation for treatment of avascular necrosis of the femoral head after femoral neck fracture surgery. OBJECTIVE: To investigate whether porous tantalum rod implantation can improve the hip joint function of patients with avascular necrosis of the femoral head subjected to femoral neck fracture surgery. METHODS: This is a prospective, single-center, randomized, controlled, open trial, which will be performed in the Department of Orthopedic Trauma, Qinghai University Affiliated Hospital, China. A total of 100 patients with avascular necrosis of the femoral head subjected to femoral neck fracture surgery will be randomly assigned to undergo core decompression and porous tantalum rod implantation (experimental group, n=50) or only core decompression (control group, n=50). All patients will be followed up for 1 year. Primary outcome measure is the percentage of patients whose hip joint function is graded as excellent as per Harris scores 12 months after surgery in total patient number in each group, which will be used to evaluate the recovery of hip joint function. Secondary outcome measures include (1) the percentage of patients with excellent hip joint function 1 and 6 months after surgery in total patient number in each group; (2) Visual Analogue Scale spine score prior to and 1, 6 and 12 months after surgery, which will be used to evaluate the severity of pain; (3) the percentage of patients presenting with femoral head collapse, prosthesis loosening and peri-prosthesis infection 6 and 12 months after surgery, which will be used to evaluate the biocompatibility of biomaterial with host; and (4) incidence of complications 6 and 12 months after surgery, which will be used to evaluate the safety of porous tantalum rod implantation. This study protocol has been approved by the Medical Ethics Committee of Qinghai University Affiliated Hospital of China (approval number: QHY1016B) 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. DISCUSSION: This study is powered to validate the biocompatibility and therapeutic effects of porous tantalum rods in the treatment of avascular necrosis of the femoral head after femoral neck fracture surgery, which hopes to provide a novel persuasive surgical treatment method for this disease. Subject headings: tissue engineering; femoral neck fractures; hip joint Cite this article: Zhang HL, Deng MH, Yang JC. Porous tantalum rod implantation improves the hip joint function of patients with avascular necrosis of the femoral head after femoral neck fracture surgery: study protocol for a randomized controlled trial. Zhongguo Zuzhi Gongcheng Yanjiu. 2016;20(34):5163-5168. 0 Introduction [1-6] [7] [8] 5164 P.O. Box 10002, Shenyang 110180
. Web of Science 1Methods/Design 1.1 1.2 (n=100) (n=50) (n=50) 1 6 12 Harris 1 Figure 1 Flow chart of the study protocol 1.3 100250 1 ( 1) 1.4 (1)12 XCT (2)2016 12017 5 31 (3) (4)18 80 (5) (6) (1) (2) (3) 1 (4) (5) (1) (2) (3) 1.5 () () 1.6 [9], 12Harris 92% PASS 14.0 β 0.1 power=90%α=0.05 93 20% 112 50 1.7 ISSN 2095-4344 CN 21-1581/R CODEN: ZLKHAH 5165
. 1.8 1 d SPSS 19.0(SPSS Chicago, IL USA)100 100 2 1.9 1.10 2.0 cm 3.2 mm( ) C X 5 mm6 mm 10 mm AVN (Trabecular Metal), Zimmer, Co. USA 10 mm70 130 mm5 mm 25 mm14 mm CX 2 cm2.5 mm 1 5 mm 9 12 mm 24 h 48 h 3 6 91 31 XCT 1.11 12Harris Harris10090 80 89 70 79 <70 (1)1 6Harris (2)1 6 12 0 10 00< 33< 66< 10 [10] (3)6 12 XCT 3 (4)6 12 1.12 1 1.13 (Case Report Form, CRF) ( ) Epidata (IDMC) 5166 P.O. Box 10002, Shenyang 110180
. 1 Table 1 Timing of outcome measure assessment 1 6 12 Harris Harris (1)(2) 24 h (IRB) www.figshare. com 1.14 SPSS 19.0 (mean)(sd) (min)(max) (q1)(median)(q3) 12Harris 6 12 Mcnemar 2 1 6 12 Mann-Whitney U α=0.05 1.15 3 1.16 2 2Discussion 2.1 2.2 [8] 50 X [11-20] 1 2.3 12Harris 92% CNKI 3 ISSN 2095-4344 CN 21-1581/R CODEN: ZLKHAH 5167
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