Abstract
Background:
Previous studies have reported that extracorporeal shock wave (EPSW) combined spinal core decompression (SCD) has been used for the treatment of patients with femoral head necrosis (FHN) effectively. However, their results are still inconsistent. Therefore, this study will systematically assess the efficacy and safety of EPSW and SCD for the treatment of patients with FHN.
Methods:
This study will systematically search the following databases from inception through March 1, 2020: MEDLINE, Web of Science, Scopus, EMBASE, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, and China National Knowledge Infrastructure. All searches will be performed without language and publication date restrictions. This study will only include randomized controlled trials investigating the efficacy and safety of EPSW and SCD for the treatment of patients with FHN. Two authors will independently assess all literatures, extract data, and appraise risk of bias. Any confusion between 2 authors will be cleared up by a third author through discussion. RevMan 5.3 software will be utilized to analyze the data and to perform a meta-analysis if necessary.
Results:
This study will summarize up-to-date evidence and provide a detailed summary related to the efficacy and safety of EPSW and SCD for the treatment of patients with FHN.
Conclusion:
This study may provide helpful evidence to determine whether or not EPSW combined SCD is effective and safety for the treatment of patients with FHN.
Systematic review registration:
INPLASY202040092.
Keywords: efficacy, extracorporeal shock wave, femoral head necrosis, spinal core decompression
1. Introduction
Femoral head necrosis (FHN) is a chronic painful bone disease in people aged 20 to 40 years old.[1–4] It is estimated that about 20,000 to 30,000 patients are diagnosed with FHN annually in the USA.[5] It can not be treated effectively and timely, it is more likely to cause femoral neck fractures.[6–14] Published studies have reported that extracorporeal shock wave (EPSW) combined spinal core decompression (SCD) can help to manage patients with FHN.[15–21] However, there is not systematic review that evaluates the efficacy and safety of EPSW and SCD for the treatment of patients with FHN. The present study aims to assess the efficacy and safety of EPSW combined SCD for the treatment of FHN.
2. Methods and analysis
2.1. Study registration
This protocol has been registered on INPLASY202040092, and it has been organized following the guideline of Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol statement.[22–23]
2.2. Eligibility criteria for study selection
2.2.1. Types of study
We will include randomized controlled trials (RCTs) that evaluated the efficacy and safety of EPSW and SCD for the treatment of patients with FHN. We will exclude literatures that belong to the animal studies, non-clinical trials, uncontrolled clinical trials, and quasi-RCTs.
2.2.2. Types of participant
We will include patients who were diagnosed with FHN, regardless their country, race, gender, and duration and severity of FHN.
2.2.3. Types of intervention
2.2.3.1. Interventions
In the experimental group, all patients must receive EPSW combined SCD therapy alone. Any combined therapies with EPSW or/ and SCD will be excluded.
2.2.3.2. Comparators
In the control group, all participants could undergo any treatments without limitations. However, we will exclude studies that involved treatments of EPSW or/ and SCD.
2.2.4. Types of outcome measurement
Primary outcome is pain intensity (assessed by any pain scales, such as Numerical Rating Scale).
Secondary outcomes are pain, stiffness, and physical function of attacked knee and hip joints (as measured by Western Ontario and McMaster Universities Osteoarthritis Index or other relevant tools); and health-related quality of life (as identified by 36-Item Short Form Health Survey or other related scores), and adverse events.
2.3. Literature search
We will systematically search MEDLINE, Web of Science, Scopus, EMBASE, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, and China National Knowledge Infrastructure. We will search each electronic database from inception through March 1, 2020 without language and publication date limitations. This study will only consider RCTs that explored the efficacy and safety of EPSW and SCD for the treatment of patients with FHN. The search strategy for MEDLINE is created in Table 1. We will also build similar search strategies for other electronic databases.
Table 1.
Search strategy utilized for MEDLINE.
In addition, we will investigate other literature sources to avoid missing potential studies, such as conference abstracts and reference lists of related reviews.
2.4. Study selection
The titles/abstracts of searched literatures will be scanned by 2 independent authors to identify studies that potentially fulfill the predetermined eligibility criteria, and duplicates and irrelevant records will be removed. The full-text of those potential eligible studies will be obtained and further determined against all inclusion criteria. We will note any excluded studies with reasons and will be listed them in a table. Any inconsistencies between 2 authors will be solved by a third author through discussion. The process of study selection with details is showed in a flowchart.
2.5. Data extraction and management
Two independent authors will extract data utilizing predefined data acquisition sheet. Any discrepancies between 2 authors will be resolved by a third author through consultation, and a consensus will be reached. The sheet includes study characteristics (study identification, time of publication, country, et al), study population (country, age, inclusion and exclusion criteria, et al), study design (sample size, details of randomization, blind, et al), intervention and comparison (treatment types, dosage, frequency, et al), outcomes, safety, results, findings, and other related information.
2.6. Missing data dealing with
Any insufficient or missing information will be requested from original authors by email or telephone. An intention-to-treat analysis will be applied to analyze outcome data. We will discuss its possible affects on the study findings as a limitation.
2.7. Risk of bias assessment
Risk of bias for all included RCTs will be appraised by 2 independent authors using Cochrane Risk of Bias Tool. Each study will be evaluated through 7 aspects and each criteria will be valued as low, unclear or high risk of bias. Differences between 2 authors will be settled through consensus with the help of a third author.
2.8. Statistical analysis
2.8.1. Data synthesis
We will use RevMan 5.3 software to analyze the data, and to perform a meta-analysis if necessary. Any dichotomous data (such as incidence of adverse events) will be calculated as risk ratio and 95% confidence intervals, and any continuous data (such as pain intensity) will be rated as mean difference or standardized mean difference and 95% confidence intervals. Statistical heterogeneity will be checked using I2 test. I2 ≤ 50% suggests little or no statistical heterogeneity, and we will employ a fixed-effects model. If sufficient trials are included with little or no statistical heterogeneity, we will consider conducting a meta-analysis. I2 > 50% means obvious heterogeneity, and we will place a random-effects model. A subgroup analysis will be performed to investigate possible sources of remarkable heterogeneity. If necessary, we will also carry out a narrative summary.
2.8.2. Subgroup analysis
If sufficient data is available, a subgroup analysis will be conducted to identify the sources of obvious heterogeneity according to the differences in study and patient characteristics, types of interventions and comparators, and outcomes.
2.8.3. Sensitivity analysis
A sensitivity analysis will be carried out to examine the robustness of the study findings according to the methodological weaknesses and missing data.
2.8.4. Publication bias
A funnel plot and Egger test will be investigated to identify the publication biases if more than 10 RCTs are included.
2.8.5. Summary of evidence
Two authors will independently assess the quality of evidence for each outcome by Grading of Recommendations Assessment, Development, and Evaluation System approach.[24,25] Any opposition will be solved by a consensus through discussion with the help of a third author.
2.9. Dissemination and ethics
This study dose not needs ethical approval, since no individual patient data will be obtained. This study will be planed to be published through a peer-reviewed journal.
3. Discussion
A growing number of clinical studies have investigated the efficacy and safety of EPSW combined SCD for the treatment of FHN. However, no evidence is presented at evidence-based medicine level. The present work provides a protocol of systematic review of previous clinical trials that examined the efficacy and safety of EPSW combined SCD for the treatment of FHN. The results of this study will timely supply a detailed and summary of the existing evidence of EPSW combined SCD for the treatment of FHN. It will also provide reference and recommendation for clinical practice and future studies.
Author contributions
Conceptualization: Yu Xue, Qing-hui Ji.
Data curation: Xiao-feng Qiao, Shi-chen Liu, Qing-hui Ji.
Investigation: Qing-hui Ji.
Formal analysis: Xiao-feng Qiao, Shi-chen Liu, Yu Xue.
Methodology: Xiao-feng Qiao, Shi-chen Liu, Yu Xue.
Project administration: Qing-hui Ji.
Resources: Xiao-feng Qiao, Shi-chen Liu, Yu Xue.
Software: Xiao-feng Qiao, Shi-chen Liu, Yu Xue.
Supervision: Qing-hui Ji.
Validation: Xiao-feng Qiao, Shi-chen Liu, Qing-hui Ji.
Visualization: Xiao-feng Qiao, Yu Xue, Qing-hui Ji.
Writing – original draft: Xiao-feng Qiao, Shi-chen Liu, Qing-hui Ji.
Writing – review and editing: Xiao-feng Qiao, Shi-chen Liu, Yu Xue, Qing-hui Ji.
Footnotes
Abbreviations: EPSW = extracorporeal shock wave, FHN = femoral head necrosis, RCTs = randomized controlled trials, SCD = spinal core decompression.
How to cite this article: Qiao Xf, Liu Sc, Xue Y, Ji Qh. Efficacy of extracorporeal shock wave combined spinal core decompression for the treatment of patients with femoral head necrosis: a protocol for systematic review and meta-analysis. Medicine. 2020;99:21(e20350).
X-FQ and S-CL contributed equally to this study.
This study was supported by Heilongjiang Provincial Universities Basic Research Business Expenses Research Project (2017-KYYWF-0574).The supporter did not involve in the whole process of this study.
The authors have no conflicts of interest to disclose.
Data sharing not applicable to this article as no datasets were generated or analyzed during the current study.
References
- [1].Simank HG, Krämer KL. Femoral head necrosis in adults. Z Orthop Unfall 2007;145:535–8. [PubMed] [Google Scholar]
- [2].Kramer J, Scheurecker G, Scheurecker A, et al. Femoral head necrosis. Radiologe 2009;49:410–8. [DOI] [PubMed] [Google Scholar]
- [3].Arbab D, König DP. Atraumatic femoral head necrosis in adults. Dtsch Arztebl Int 2016;113:31–8. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [4].Larson E, Jones LC, Goodman SB, et al. Early-stage osteonecrosis of the femoral head: where are we and where are we going in year 2018? Int Orthop 2018;42:1723–8. [DOI] [PubMed] [Google Scholar]
- [5].Moya-Angeler J, Gianakos AL, Villa JC, et al. Current concepts on osteonecrosis of the femoral head. World J Orthop 2015;6:590–601. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [6].Wang Y, Ma JX, Yin T, et al. Correlation between reduction quality of femoral neck fracture and femoral head necrosis based on biomechanics. Orthop Surg 2019;11:318–24. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [7].Deleanu B, Prejbeanu R, Crisan D, et al. Combined bilateral femoral head necrosis and pertrochanteric fracture: a case report. J Med Case Rep 2015;9:25. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [8].Wang T, Sun JY, Zha GC, et al. Analysis of risk factors for femoral head necrosis after internal fixation in femoral neck fractures. Orthopedics 2014;37:1117–23. [DOI] [PubMed] [Google Scholar]
- [9].Bonnaire FA, Weber AT. The influence of haemarthrosis on the development of femoral head necrosis following intracapsular femoral neck fractures. Injury 2002;33: Suppl 3: C33–40. [DOI] [PubMed] [Google Scholar]
- [10].Neander G, von Sivers K, Adolphson P, et al. An evaluation of bone loss after total hip arthroplasty for femoral head necrosis after femoral neck fracture: a quantitative CT study in 16 patients. J Arthroplasty 1999;14:64–70. [DOI] [PubMed] [Google Scholar]
- [11].Messmer P, Soklić P, Matter P. Femoral neck fracture and femoral head necrosis. Helv Chir Acta 1993;59:993–7. [PubMed] [Google Scholar]
- [12].Langer R, Langer M, Scholz A, et al. Femoral head perfusion in patients with femoral neck fracture and femoral head necrosis. J Belge Radiol 1993;76:145–9. [PubMed] [Google Scholar]
- [13].Linde F, Andersen E, Hvass I, et al. Avascular femoral head necrosis following fracture fixation. Injury 1986;17:159–63. [DOI] [PubMed] [Google Scholar]
- [14].Cai RB, Mou DC, Nie QD, et al. Early scintigraphic diagnosis of femoral head necrosis following femoral neck fractures. Chin Med J (Engl) 1983;96:897–901. [PubMed] [Google Scholar]
- [15].Nie SC, Wu B. Progress in treatment of necrosis of femoral head. Clinical Research of Traditional Chinese Medicine 2018;10:144–8. [Google Scholar]
- [16].Li JW. Recent clinical study of core decompression fibular column support combined with extracorporeal shock wave for early and mid-term femoral head necrosis. Henan Traditional Chinese Medicine 2018. [Google Scholar]
- [17].Cao H, Liu MT, Shi H. Current status of extracorporeal shock waves in the treatment of early adult femoral head necrosis. Chinese Journal of Orthopaedic Surgery 2017;25:2165–8. [Google Scholar]
- [18].Liu J, Hao YQ, Wang YG, et al. Research progress of femoral head necrosis and head preservation. Hunan Journal of Traditional Chinese Medicine 2017;33:18–24. [Google Scholar]
- [19].Wu Z, Feng YY, Yin YB, et al. Comparative study on the long-term clinical efficacy of extracorporeal shock wave and core decompression in the treatment of early femoral head necrosis. Journal of Traumatic Surgery 2017;19:48–51. [Google Scholar]
- [20].Cao J. Analysis of clinical efficacy of ESWT combined with core decompression in the treatment of early avascular necrosis of femoral head. Shanxi Medical University 2016. [Google Scholar]
- [21].Wang T. Bone grafting combined with bone marrow mesenchymal stem cell transplantation for the treatment of femoral head necrosis [D]. Anhui Medical University 2013. [Google Scholar]
- [22].Moher D, Shamseer L, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev 2015;4:1. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [23].Shamseer L, Moher D, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ 2015;349:g7647. [DOI] [PubMed] [Google Scholar]
- [24].Guyatt GH, Oxman AD, Vist GE, et al. Grade: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924–6. [DOI] [PMC free article] [PubMed] [Google Scholar]
- [25].Guyatt GH, Oxman AD, Schünemann HJ, et al. Grade guidelines: a new series of articles in the Journal of clinical epidemiology. J Clin Epidemiol 2011;64:380–2. [DOI] [PubMed] [Google Scholar]