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Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage Femur Head Necrosis: Protocol for a randomized controlled trial

BACKGROUND: Early diagnosis and treatment of the osteonecrosis of the femoral head (ONFH), a refractory disease, is imperative to prevent femoral head collapse; however, the existing solutions remain controversial. This study assessed the safety and efficacy of extracorporeal shock wave therapy (ESW...

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Autores principales: Li, Qianchun, Chen, Rigao, Yu, Yang, Wang, Xinling, Feng, Xueya, Jiang, Leiming, Chen, Botao, Xin, Peng, Li, Tong, Shi, Yin, Jian, Qiang, Jiang, Zhongchao, Fan, Xiaohong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7535671/
https://www.ncbi.nlm.nih.gov/pubmed/33019480
http://dx.doi.org/10.1097/MD.0000000000022598
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author Li, Qianchun
Chen, Rigao
Yu, Yang
Wang, Xinling
Feng, Xueya
Jiang, Leiming
Chen, Botao
Xin, Peng
Li, Tong
Shi, Yin
Jian, Qiang
Jiang, Zhongchao
Fan, Xiaohong
author_facet Li, Qianchun
Chen, Rigao
Yu, Yang
Wang, Xinling
Feng, Xueya
Jiang, Leiming
Chen, Botao
Xin, Peng
Li, Tong
Shi, Yin
Jian, Qiang
Jiang, Zhongchao
Fan, Xiaohong
author_sort Li, Qianchun
collection PubMed
description BACKGROUND: Early diagnosis and treatment of the osteonecrosis of the femoral head (ONFH), a refractory disease, is imperative to prevent femoral head collapse; however, the existing solutions remain controversial. This study assessed the safety and efficacy of extracorporeal shock wave therapy (ESWT) combined with multiple drilling and intramedullary drug injection, a novel cocktail therapy, as a randomized controlled trial (RCT) model to postulate an alternative therapy for patients with early-stage ONFH. METHODS: Femoral head necrosis patients aged 20 to 60 years with stage ARCO I-II were recruited. One hundred twenty eligible participants were randomized into four groups in a 1:1:1:1 ratio: extracorporeal shock wave therapy combined with multiple drilling and intramedullary drug injection (group EMI), extracorporeal shock wave therapy (group E), multiple drilling combined with intramedullary drug injection (group MI), and multiple drilling (“positive” control group; group M). The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema. Secondary outcomes included the Harris Hip Score and the visual analog scale. All outcomes were measured at the screening visit (baseline) and at the planned time intervals during treatment and follow-up, and the efficacy was statistically analyzed according to the intention-to-treat sub-populations and per-protocol sub-populations. OBJECTIVES: To examine the clinical efficacy of ESWT combined with multiple drilling and intramedullary drug injection to provide a safe and more effective method for treating early-stage ONFH. TRIAL REGISTRATION NUMBER: ChiCTR1900020888; Pre-results.
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spelling pubmed-75356712020-10-14 Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage Femur Head Necrosis: Protocol for a randomized controlled trial Li, Qianchun Chen, Rigao Yu, Yang Wang, Xinling Feng, Xueya Jiang, Leiming Chen, Botao Xin, Peng Li, Tong Shi, Yin Jian, Qiang Jiang, Zhongchao Fan, Xiaohong Medicine (Baltimore) 6300 BACKGROUND: Early diagnosis and treatment of the osteonecrosis of the femoral head (ONFH), a refractory disease, is imperative to prevent femoral head collapse; however, the existing solutions remain controversial. This study assessed the safety and efficacy of extracorporeal shock wave therapy (ESWT) combined with multiple drilling and intramedullary drug injection, a novel cocktail therapy, as a randomized controlled trial (RCT) model to postulate an alternative therapy for patients with early-stage ONFH. METHODS: Femoral head necrosis patients aged 20 to 60 years with stage ARCO I-II were recruited. One hundred twenty eligible participants were randomized into four groups in a 1:1:1:1 ratio: extracorporeal shock wave therapy combined with multiple drilling and intramedullary drug injection (group EMI), extracorporeal shock wave therapy (group E), multiple drilling combined with intramedullary drug injection (group MI), and multiple drilling (“positive” control group; group M). The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema. Secondary outcomes included the Harris Hip Score and the visual analog scale. All outcomes were measured at the screening visit (baseline) and at the planned time intervals during treatment and follow-up, and the efficacy was statistically analyzed according to the intention-to-treat sub-populations and per-protocol sub-populations. OBJECTIVES: To examine the clinical efficacy of ESWT combined with multiple drilling and intramedullary drug injection to provide a safe and more effective method for treating early-stage ONFH. TRIAL REGISTRATION NUMBER: ChiCTR1900020888; Pre-results. Lippincott Williams & Wilkins 2020-10-02 /pmc/articles/PMC7535671/ /pubmed/33019480 http://dx.doi.org/10.1097/MD.0000000000022598 Text en Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by/4.0 This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0
spellingShingle 6300
Li, Qianchun
Chen, Rigao
Yu, Yang
Wang, Xinling
Feng, Xueya
Jiang, Leiming
Chen, Botao
Xin, Peng
Li, Tong
Shi, Yin
Jian, Qiang
Jiang, Zhongchao
Fan, Xiaohong
Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage Femur Head Necrosis: Protocol for a randomized controlled trial
title Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage Femur Head Necrosis: Protocol for a randomized controlled trial
title_full Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage Femur Head Necrosis: Protocol for a randomized controlled trial
title_fullStr Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage Femur Head Necrosis: Protocol for a randomized controlled trial
title_full_unstemmed Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage Femur Head Necrosis: Protocol for a randomized controlled trial
title_short Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage Femur Head Necrosis: Protocol for a randomized controlled trial
title_sort extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage femur head necrosis: protocol for a randomized controlled trial
topic 6300
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7535671/
https://www.ncbi.nlm.nih.gov/pubmed/33019480
http://dx.doi.org/10.1097/MD.0000000000022598
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