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1 Chinese Journal of Tissue Engineering Research August 19, 2016 Vol.20, No.34 ( ). [J] (34): DOI: /j.issn ORCID: ( ) Harris X 2 cm :R318 :B : (2016) Harris 1 6 Harris (QHY1016B) ISSN CN /R CODEN: ZLKHAH 5163

2 . Zhang He-ling, Master, Attending physician, Department of Orthopedic Trauma, Qinghai University Affiliated Hospital, Xining , Qinghai Province, China Corresponding author: Zhang He-ling, Department of Orthopedic Trauma, Qinghai University Affiliated Hospital, Xining , 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 , 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): Introduction [1-6] [7] [8] 5164 P.O. Box 10002, Shenyang

3 . Web of Science 1Methods/Design (n=100) (n=50) (n=50) Harris 1 Figure 1 Flow chart of the study protocol ( 1) 1.4 (1)12 XCT (2) (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= % ISSN CN /R CODEN: ZLKHAH 5165

4 d SPSS 19.0(SPSS Chicago, IL USA) cm 3.2 mm( ) C X 5 mm6 mm 10 mm AVN (Trabecular Metal), Zimmer, Co. USA 10 mm mm5 mm 25 mm14 mm CX 2 cm2.5 mm 1 5 mm 9 12 mm 24 h 48 h XCT Harris Harris <70 (1)1 6Harris (2) < 33< 66< 10 [10] (3)6 12 XCT 3 (4) (Case Report Form, CRF) ( ) Epidata (IDMC) 5166 P.O. Box 10002, Shenyang

5 . 1 Table 1 Timing of outcome measure assessment Harris Harris (1)(2) 24 h (IRB) com 1.14 SPSS 19.0 (mean)(sd) (min)(max) (q1)(median)(q3) 12Harris 6 12 Mcnemar Mann-Whitney U α= Discussion [8] 50 X [11-20] Harris 92% CNKI 3 ISSN CN /R CODEN: ZLKHAH 5167

6 . ( ) 3 References [1] Hu LY, Jia QY, Yu Y, et al. Clinical effects of internal fixation with Herbert screws for the treatment of Pipkin femoral head fractures. Zhongguo Gu Shang. 2016; 29: [2] Li Q, Xie XR, Wang QB, et al. Treatment of fresh subtrochanteric fracture combined with old femoral neck fracture with hemiarthoplasty through anterolateral approach. Zhongguo Gu Shang. 2015; 28: [3] Kuo FC, Kuo SJ, Ko JY. Overgrowth of the femoral neck after hip fractures in children. J Orthop Surg Res. 2016;11:50. [4] Sharma N, Bache E, Clare T. Bilateral femoral neck fractures in a young patient suffering from hypophosphatasia, Due to a first time epileptic seizure. J Orthop Case Rep. 2015;5: [5] Varghese VD, Livingston A, Boopalan PR, et al. Valgus osteotomy for nonunion and neglected neck of femur fractures. World J Orthop. 2016;7: [6] Zhang YY, Zuo JL, Gao ZL. Case-control study on methods of limb length control in hip arthroplasty. Zhongguo Gu Shang. 2016;29: [7],,,. [J].,2010,30(1): [8]. [J].,2012,16(29): [9],,,. Ficat [J].( ),2010,48(7): [10] Knop C, Oeser M, Bastian L, et al. Development and validation of the Visual Analogue Scale (VAS) Spine Score. Unfallchirurg. 2011;104: [11] Kuo FC, Kuo SJ, Ko JY. Overgrowth of the femoral neck after hip fractures in children. J Orthop Surg Res. 2016;11(1):50. [12] Wan G, Sun J, Zha G, et al. Mid- and long-term effectiveness of third-generation ceramic-on-ceramic total hip arthroplasty in younger patients. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2015;29(9): [13] Chen Z, Liang X, Wu J, et al. Diagnosis and treatment of acetabular labrum injury in pipkin fracture. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2015; 29(1): [14] Sheehan SE, Shyu JY, Weaver MJ, et al. Proximal femoral fractures: what the orthopedic surgeon wants to know. Radiographics. 2015;35(5): [15] Motomura G, Yamamoto T, Karasuyama K, et al. Bone SPECT/CT of Femoral Head Subchondral Insufficiency Fracture. Clin Nucl Med. 2015;40(9): [16] Massè A, Aprato A, Alluto C, et al. Surgical hip dislocation is a reliable approach for treatment of femoral head fractures. Clin Orthop Relat Res. 2015; 473(12): [17] Yuan HF, Shen F, Zhang J, et al. Predictive value of single photon emission computerized tomography and computerized tomography in osteonecrosis after femoral neck fracture: a prospective study. Int Orthop. 2015;39(7): [18] Guo S, Sun J, Zha G, et al. Comparative study on association between femoral head size and linear wear rate of highly cross-linked polyethylene liner. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2014; 28(11): [19] Sharma G, Chadha M, Pankaj A. Hip dislocation associated with ipsilateral femoral neck and shaft fractures: an unusual combination and dilemma regarding head preservation. Acta Orthop Traumatol Turc. 2014;48(6): [20] Panigrahi R, Sahu B, Mahapatra AK, et al. Treatment analysis of paediatric femoral neck fractures: a prospective multicenter theraupetic study in Indian scenario. Int Orthop. 2015;39(6): P.O. Box 10002, Shenyang

0 Introduction (20.9%) [7]

0 Introduction (20.9%) [7] Chinese Journal of Tissue Engineering Research www.crter.org ( 443000) DOI:10.3969/j.issn.2095-4344.0187 ORCID: 0000-0003-0005-1839() 60 120 2 60 1980 2015 443000 :R318 :A 2017-12-05 3 4 120 60 () 3 (P

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