Effect of periprosthetic fracture on hip function after femoral neck-preserving total hip arthroplasty: study protocol for a prospective, single-center, self-controlled trial with 2-year follow-up

doi:10.3969/j.issn.2095-4344.2016.53.012

Abstract

Abstract:

BACKGROUND: Total hip replacement with a collum femoris preserving (CFP) short stem prosthesis can reportedly reduce postoperative complications and preserve maximum bone tissue for long-term revision. However, CFP replacement has a relatively high risk of intraoperative periprosthetic fractures that can seriously harm hip function recovery.

OBJECTIVE: To analyze risk factors for periprosthetic fractures and develop preventive measures to reduce postoperative complications.

METHODS: A prospective, single-center, self-controlled, open-label clinical study with 2-year follow-up will be carried out at the Department of Orthopedics, Third Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China. We will analyze imaging data from 25 patients who undergo total hip replacement with the CFP prosthesis. Primary outcome measure is hip function recovery as assessed by Harris hip score preoperatively and 6, 12, and 24 months postoperatively. Secondary outcome measures include fracture severity as assessed by periprosthetic fracture classification according to the American Academy of Orthopaedic Surgeons guidelines, and bone healing as assessed by CT and radiographic findings preoperatively and 6, 12, and 24 months postoperatively, including parameters of the proximal and mesal medullary cavity of the fractured femur (width of the medullary cavity at the point 20 mm above the midpoint of the small trochanter, at the midpoint of the small trochanter, at the point 20 mm below the midpoint of the small trochanter, and at the fracture line; width of the corresponding prostheses), intertrochanteric width, femoral neck-stem angle, femoral neck anteversion, femoral neck length, ratio of the distal end of the prosthesis to the medullary space, and height of the femoral calcar. Other outcome measures are multiple logistic regression analysis results of risk factors for periprosthetic fracture during hip replacement, and the incidence of adverse events within 24 months postoperatively. This study was registered at ClinicalTrials.gov (NCT 02981823) on 24 November 2016. Approved by the Ethics Committee of the Third Hospital of Hebei Medical University, China (approval number: KE2016-011-1), the study protocol will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants prior to the trial.

DISCUSSION: This study will be expected to provide references for reducing the incidence of periprosthetic fracture during hip replacement with the CFP prosthesis.

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, Arthroplasty, Replacement, Hip, Acetabulum

CLC Number:

R318

Qin Di, Han Yong-tai, Li Hui-jie. Effect of periprosthetic fracture on hip function after femoral neck-preserving total hip arthroplasty: study protocol for a prospective, single-center, self-controlled trial with 2-year follow-up[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(53): 7985-7991.

Figures/Tables 1

References

[1] Yu L, Zhang CH, Guo T, et al. Middle and long-term results of total hip arthroplasties for secondary post-traumatic arthritis and femoral head necrosis after acetabular fractures. Zhongguo Gu Shang. 2016;29(2): 109-113.

[2] Massari L, Osti R, Lorusso V, et al. Biophysical stimulation and the periprosthetic bone: is there a rationale in the use of Pulsed Electromagnetic Fields after a hip or knee implant? J Biol Regul Homeost Agents. 2015;29(4):1013-1015.

[3] Kempthorne JT, Ailabouni R, Raniga S, et al. Occult Infection in Aseptic Joint Loosening and the Diagnostic Role of Implant Sonication. Biomed Res Int. 2015;2015: 946215.

[4] Frenzel S, Vécsei V, Negrin L. Periprosthetic femoral fractures--incidence, classification problems and the proposal of a modified classification scheme. Int Orthop. 2015;39(10):1909-1920.

[5] Barut N, Anract P, Babinet A, et al. Peri-prosthetic fractures around tumor endoprostheses: a retrospective analysis of eighteen cases. Int Orthop. 2015;39(9):1851-1856.

[6] Petersen MB, Gramkow J, Retpen JA, et al. Ugeskr Laeger. Non-cemented acetabular cup in hip arthroplasty. Prosthesis survival and clinical results after 1-8 years. 1998;160(33):4772-4775.

[7] Pipino F. CFP Prosthesic stem in mini-invasive total hip arthroplasty. J Orthopaed Trauma. 2004;4:165-171.

[8] Huang X, Zhang Y, Wang Q. Medium- and long-term effectiveness of third-generation ceramic-on-ceramic total hip arthroplasty for end-stage hip disease. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2014; 28(6):669-672.

[9] Klein GR, Parvizi J, Rapuri V, et al. Proximal femoral replacement for the treatment of periprosthetic fractures. J Bone Joint Surg Am. 2005;87(8): 1777-1781.

[10] Shen J, Sun CT, Huang GY. Evaluation of the postoperative quality of life in the elderly over 80 years old who underwent hip hemiarthroplasty for femoral neck fracture. Zhonghua Wai Ke Za Zhi. 2004;42(23): 1409-1411.

[11] Yu L, Zhang CH, Guo T, et al. Middle and long-term results of total hip arthroplasties for secondary post-traumatic arthritis and femoral head necrosis after acetabular fractures. Zhongguo Gu Shang. 2016;29(2): 109-113.

[12] Stoffel K, Sommer C, Kalampoki V, et al. The influence of the operation technique and implant used in the treatment of periprosthetic hip and interprosthetic femur fractures: a systematic literature review of 1571 cases. Arch Orthop Trauma Surg. 2016;136(4): 553-561.

[13] Massari L, Osti R, Lorusso V, et al. Biophysical stimulation and the periprosthetic bone: is there a rationale in the use of Pulsed Electromagnetic Fields after a hip or knee implant? J Biol Regul Homeost Agents. 2015;29(4):1013-1015.

[14] Frenzel S, Vécsei V, Negrin L. Periprosthetic femoral fractures--incidence, classification problems and the proposal of a modified classification scheme. Int Orthop. 2015;39(10):1909-1920.

[15] Barut N, Anract P, Babinet A, et al. Peri-prosthetic fractures around tumor endoprostheses: a retrospective analysis of eighteen cases. Int Orthop. 2015;39(9):1851-1856.

[16] Dickinson AS. Activity intensity, assistive devices and joint replacement influence predicted remodelling in the proximal femur. Biomech Model Mechanobiol. 2016;15(1):181-194.

[17] Ehlinger M, Bahlau D, Rahme M, et al. Has a patient type with peri-prosthetic femoral fractures evolved? Int Orthop. 2015 Sep;39(9):1833-1838.

[18] Russo M, Malekzadeh AS, Hampton C, et al. Reversed Contralateral LISS Plate for Vancouver B1 Periprosthetic Femoral Shaft Fractures. Orthopedics. 2015;38(6):e467-e472.

[19] Graham SM, Mak JH, Moazen M, et al. Periprosthetic femoral fracture fixation: a biomechanical comparison between proximal locking screws and cables. J Orthop Sci. 2015;20(5):875-880.

[20] Kim Y, Tanaka C, Tada H, et al. Treatment of periprosthetic femoral fractures after femoral revision using a long stem. BMC Musculoskelet Disord. 2015; 16:113.

[21] 中华医学会骨科分会显微修复学组.成人股骨头坏死诊疗标准专家共识(2012年版)[J].中华骨科杂志,2012, 32(6):185-192.

[22] Gardeniers JWM. The ARCO perspective for reaching one uniform staging system of osteonecrosis. Bone circulation and vascularization in narmal and pathological conditions. New York: Plenum, USA. 1993.