Effectiveness and safety of cemented versus cementless hip arthroplasty for senile unstable intertrochanteric fractures: study protocol for a prospective, nonrandomized, controlled clinical trial

doi:10.3969/j.issn.2095-4344.2017.15.003

Abstract

Abstract:

BACKGROUND: For elderly patients with unstable intertrochanteric fractures, hip arthroplasty is mainly applied due to the degenerative body function and difficulty in reduction.

OBJECTIVE: To investigate the effectiveness and safety of cemented versus cementless hip arthroplasty for senile unstable intertrochanteric fractures.

METHODS: We are conducting a prospective, single-center, non-randomized, controlled clinical trial at the Harrison International Peace Hospital, China. Eighty-six elderly patients with unstable intertrochanteric fractures were enrolled and allotted to control (n=44) and experimental (n=42) groups, followed by treated with cemented and cementless hip arthroplasty, respectively. The follow-up time is 6 months. The primary outcome is good and excellent rate according to Harris hip scores at 6 months postoperatively. The secondary outcomes are Harris hip scores and hip morphology on X-ray at 1, 3 and 6 months postoperatively, intraoperative blood loss, operation time, blood transfusion volume, time of off-bed and drainage volume at 1 month postoperatively, as well as the safety based on the incidence of adverse events at 6 months postoperatively. Partial results show that the blood transfusion volume and drainage volume postoperatively in the experimental group were significaintly higher than those in the control group (P < 0.05). There were no significant differences in the good and excellent rate according to Harris hip scores, Harris hip scores and incidence of adverse events between two groups at 6 months postoperatively (P > 0.05). There were four cases of bone cement implantation syndrome in the control group. The study protocol has been approved by the Ethics Committee of Harrison International Peace Hospital of China, approval number 2013-37. All protocols will be performed in accordance with the Ethical Principles for Medical Research Involving Human Subjects in the Declaration of Helsinki. Written informed consent was provided by each patient and their family members after they indicated that they fully understood the treatment plan.

DISCUSSION: Cases were collected in January 2014 and the trial will be finished in December 2017. Cemented and cementless hip arthroplasty are mainly used to treat senile unstable intertrochanteric fractures. This study is designed to investigate the differences between cemented and cementless hip arthroplasty, thus providing referece for the treatment of unstable intertrochanteric fractures in the elderly. Partial trial results indicate that both cemented and cementless hip arthroplasties exhibit good curative efficacy and safety for senile unstable intertrochanteric fractures, while the occurrence of bone cement implantation syndrome in cemented hip arthroplasty should never be neglected.

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

Key words: Tissue Engineering, Hip Joint, Femur

CLC Number:

R318

Yu Tie-miao, Miao Hui-ling. Effectiveness and safety of cemented versus cementless hip arthroplasty for senile unstable intertrochanteric fractures: study protocol for a prospective, nonrandomized, controlled clinical trial [J]. Chinese Journal of Tissue Engineering Research, 2017, 21(15): 2308-2313.

Figures/Tables 3

References

[1] Liang C, Peng R, Jiang N, et al. Intertrochanteric fracture: association between the coronal position of the lag screw and stress distribution. Asian J Surg. 2017 doi: 10.1016/j.asjsur.2017.02.003.

[2] Kempegowda H, Richard R, Borade A, et al. Obesity is associated with high peri-operative complications among surgically treated intertrochanteric fracture of the femur. J Orthop Trauma. 2017 doi: 10.1097/BOT.0000000000000825.

[3] Yoo JI, Ha YC, Lim JY, et al. Early rehabilitation in elderly after arthroplasty versus internal fixation for unstable intertrochanteric fractures of femur: systematic review and meta-analysis. J Korean Med Sci. 2017;32(5):858-867.

[4] Yang S, Liu Y, Yang T, et al. Early clinical efficacy comparison study of gamma3 nail, percutaneous compression plate (PCCP) and femoral head replacement (FHR) treatment on senile unstable intertrochanteric fractures. J Invest Surg. 2017 doi: 10.1080/08941939.2017.1282558.

[5] Sun D, Park BS, Jang GI, et al. The fixation method according to the fracture type of the greater trochanter in unstable intertrochanteric fractures undergoing arthroplasty. Hip Pelvis. 2017;29(1):62-67.

[6] Sonmez MM, Camur S, Erturer E, et al. Strategies for proximal femoral nailing of unstable intertrochanteric fractures: lateral decubitus position or traction table. J Am Acad Orthop Surg. 2017 doi: 10.5435/JAAOS-D-15-00691.

[7] Yoo JI, Ha YC, Lim JY, et al. Early rehabilitation in elderly after arthroplasty versus internal fixation for unstable intertrochanteric fractures of femur: systematic review and meta-analysis. J Korean Med Sci. 2017 doi: 10.3346/jkms.2017.32.5.858.

[8] Wada K, Mikami H, Oba K, et al. Cementless calcar-replacement stem with integrated greater trochanter plate for unstable intertrochanteric fracture in very elderly patients. J Orthop Surg (Hong Kong). 2017 doi: 10.1177/2309499016684749.

[9] Arslan A, Utkan A, Koca TT. Results of a compression pin alongwith trochanteric external fixation in management of high risk elderly intertrochanteric fractures. Indian J Orthop. 2016;50(6):636-640.

[10] Resch H, Krappinger D, Moroder P, et al. Treatment of periprosthetic acetabular fractures after previous hemi- or total hip arthroplasty: Introduction of a new implant. Oper Orthop Traumatol. 2016;28(2):104-110.

[11] Kashigar A, Vincent A, Gunton MJ, et al. Predictors of failure for cephalomedullary nailing of proximal femoral fractures. Bone Joint J. 2014;96-B(8):1029-1034.

[12] Hoff P, Maschmeyer P, Gaber T, et al. Human immune cells' behavior and survival under bioenergetically restricted conditions in an in vitro fracture hematoma model. Cell Mol Immunol. 2013;10(2):151-158.

[13] Renken F, Renken S, Paech A, et al. Early functional results after hemiarthroplasty for femoral neck fracture: a randomized comparison between a minimal invasive and a conventional approach. BMC Musculoskelet Disord. 2012;13:141.

[14] Chen DW, Lin CL, Hu CC, et al. Finite element analysis of different repair methods of Vancouver B1 periprosthetic fractures after total hip arthroplasty. Injury. 2012;43(7): 1061-1065.

[15] Frenkel Rutenberg T, Daglan E, Heller S, et al. comparison of treatment setting for elderly patients with hip fracture, is the geriatric ward superior to conventional orthopedic hospitalization? Injury. 2017. pii: S0020-1383(17)30277-2.

[16] Zhang YM, Jiang X, Sun YS. Effect of rivaroxaban on preventing deep-vein thrombosis in aged diabetics with femoral neck fractures after hip replacement. Biosci Rep. 2017. doi: 10.1042/BSR20170289.

[17] Dudko S, Kosior P, Kusz D, et al. Factors Influencing Treatment of Proximal Femoral Fractures. Ortop Traumatol Rehabil. 2017. doi: 10.5604/15093492.1235277.

[18] Kumar N, Wayne-Yap MQ, Ebk K. Lumbosacral Plexopathy in Pelvic Injury - A Cause of Hip Instability in Acetabular Fractures: A Report of Two Cases. Malays Orthop J. 2016; 10(2):61-65.

[19] Thakur A, Lal M. Cemented Hemiarthroplasty in Elderly Osteoporotic Unstable Trochanteric Fractures using Fracture Window. Malays Orthop J. 2016;10(1):5-10.

[20] Wang Z, Bhattacharyya T. Outcomes of Hemiarthroplasty and Total Hip Arthroplasty for Femoral Neck Fracture: A Medicare Cohort Study. J Orthop Trauma. 2017. doi: 10.1097/BOT.0000000000000814.

[21] Yan M, Wang B, Li Y, et al. Analysis of prosthesis-related complications after extensible semi-joint prosthesis replacement for lower limbs osteosarcoma in children. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2015;29(10): 1194-1198.

[22] 吕龙,牛啸博,张剑君,等.生物型加长柄关节置换治疗高龄股骨转子问骨折[J].中华骨科杂志,2012,32(7):637-641.

[23] Castilian P, Bartra A, Vallro G, et al. Hip arthroplasty with conventional stem as rescue treatment after failed treatment of intertrochanteric hip fractures. Rev Esp Cir Ortop Tranmatol. 2013;57(3):194-200.

[24] Barrack RL, Mulroy RD, Harris WH. Improved cementing techniques and femoral component loosening in young patients with hip arthroplasty. A 12-year radiographic review. J Bone Joint Surg Br. 1992;74(3):385-389.

[25] Brooker AF, Bowerman JW, Robinson RA, et al. Ectopic ossiflcation following total hip replacement. J Bone Joint Surg (Br). 1973;55(8):1629-1632.

[26] Jensen JS,Michaelsen M. Trochanteric femoral fractures treated with McLaughlin osteosynthesis. Acta Orthop Scand. 1975;46(5):795-803.

[27] Singh M, Nagrath AR, Malni PS. Changes in trabecular pattern of the upper end of the femuran index of osteoporosis. J Bone Joint Surg Am. 1970;52(3):457-467.

[28] 成世高,王万春,肖扬,等.骨水泥型人工股骨头置换治疗高龄不稳定型股骨转子间骨折[J].中国组织工程研究, 2015,19(52): 8373-8378.

[29] Liu GB, Zhang GP, Ren QY, et al. Classification of ankle injury on radiography and magnetic resonance imaging: study protocol for a retrospective, self-controlled, clinical trial with 3-month followup. Clin Transl Orthop. 2016;1(4):170-176.

[30] Chen Y, Qu S, Ma G, Meng JH, Ni XL. Femoral nerve block prevents deep venous thrombosis of the lower extremity after knee arthroplasty: a single-center randomized controlled trial. Clin Transl Orthop. 2016;1(1):1-5.