Keywords
Core decompression, hip, avascular necrosis, hip preservation, femoral head, avn.
Core decompression, hip, avascular necrosis, hip preservation, femoral head, avn.
Osteonecrosis or avascular necrosis (AVN) of the femoral head is a challenging condition that eventually leads, in the majority of cases, to a total hip replacement (THR)1–3. The patients affected by the condition are usually young and therefore may require revision surgery and multiple further procedures4. The aetiology is varied and includes multiple conditions that can lead to a reduced blood supply in the femoral head: oral corticosteroids, systemic lupus erythematosus, binge consumption of alcohol, Gaucher disease, sickle cell anaemia, trauma, thrombosis amongst others5. Furthermore, staging systems for AVN are different across the literature and pose a significant problem in assessing surgical indications and stratifying outcome6. The most common classification systems used are: Ficat7/ Modified Ficat8; “University of Pennsylvania”/Steinberg6; and ARCO (Association Research Circulation Osseous)9.
Core decompression is a common surgical procedure that has been used earlier on in the disease process to decrease the intraosseous pressure in the femoral head, relieve pain and potentially re-establish blood flow. Furthermore, multiple augmentation techniques have recently been described that seem to significantly improve the outcome following this procedure10,11.
However, the eventual outcome and time to THR following this procedure remains controversial12–16. It is also not clear whether a mechanical decompression alone is sufficient and efficient in all stages of AVN in order to prevent progression and delay the need of a THR. To the best of our knowledge, the largest published systematic review on this subject included only four studies for analysis17.
The purpose of this study, therefore, was to assess the outcomes of core decompression without any augmentation for nontraumatic AVN of the femoral head.
The Preferred Reporting Items for Systematic Reviews and Meta-analysis – Protocol (PRISMA-P) guidelines will be used to develop the protocol of the study. The manuscript will then be developed using the PRISMA statement and flowchart. This systematic review is registered in the International Prospective Register for Systematic Reviews and Meta-analysis (PROSPERO) under the registration number: CRD42018100596.
The search for articles will include several databases, Medline, Embase, Google Scholar and the Cochrane library. There will be no restriction on dates and articles will be included from inception. The search strings will include articles looking at patients with AVN and having core decompression and they will then be combined using the Boolean terms AND/OR. A total of eight combinations of the following keywords will be used: “femoral head” with “osteonecrosis”, “avascular necrosis”, “aseptic necrosis”, “avn” with the terms - “core decompression” or “surgery”.
First, a blinded and independent process of selection based on title and abstract will be made by two authors (OA and HS). Secondly, a thorough analysis of eligible studies was performed by evaluating full texts. Studies will then be screened according to the inclusion and exclusion criteria (Table 1). Articles included would be in English language, looking at those suffering from AVN and those who had core decompression only. Reviews, editorials and commentaries will be excluded. The PICO tool is used to formulate the research question. The participants will be everyone with no restriction to age, race or gender, the intervention is core decompression, there will be no comparator, and the outcomes will include clinical and radiological (Table 2).
The selected articles will then be exported to Mendeley reference manager software and all duplicates will be removed electronically and manually. The final number of included articles will then be assessed for full text review and data will be extracted based on a pre-determined set of variables. Two reviewers (AO and OW) will assess and screen and if there is any discrepancy, a third more senior reviewer (VK) will be invited to advice until consensus is met between all authors. Data extracted will then be pulled into a spreadsheet with the pre-determined variables on Microsoft Excel v16.21.
The extracted data will based on the following table headings: author, study setting (country and year), number of included hips, average follow up, gender percentages, average age, mean Body Mass Index (BMI), preliminary diagnosis (primary etiology), stage of disease, surgical technique, clinical outcome (with preoperative and postoperative results where applicable), radiological outcome and time to THR.
The risk of bias and quality of studies will be evaluated using the Joanna Briggs Institute Critical Appraisal Checklist18 for each study design due to its rigor in assessing the methodological integrity of studies. The outcomes of core decompression will include clinical and radiological outcomes. In addition, the total mean time for hip replacement among all the studies will be estimated. Based on the quality of studies included, a meta-analysis might be conducted across the studies if there was limited heterogeneity in the data.
In cases of changes in the existing protocol that significantly would affect the accuracy of data, scope of the investigation, or scientific quality of the study, edits will be performed and a newer version that would be in accordance with the final systematic review, will be provided and published.
Ongoing.
Classification systems, outcome measures and reporting systems are highly variable amongst studies assessing and reporting the outcome of core decompression for AVN of the femoral head. From distinct classifications (Ficat or its modification, Steinberg, ARCO) to varied clinical scores (Harris Hip Score/D’Aubigne/Visual Analogue Scale), all have been described and used in the literature.
Furthermore, the concept of “procedural success” is not absolute. Whilst most studies consider the absence of radiological progression of disease to be the main finding that suggests success, other authors interpret clinical improvement as success, even in the presence of radiological deterioration. Therefore, the heterogeneity of interpretation of success in the studies extracted may not allow for a uniform representation. As such, the results will be represented in separate categories, based on the classification system that was used and divided into radiological progression and another category of clinical improvement.
The strengths of our study will be represented by the largest patient pool and rigorous exclusion criteria that will be used. Any collateral influence of aetiology (traumatic), systemic disease (sickle cell crisis) or technique heterogeneity (presence of augmentation or bone grafts) will be excluded. Also, there will be a tenacious stratification based on stage of the disease even in the presence of a variety of classification systems. Ultimately, the following questions will be evaluated and answered:
1) Does core decompression accomplish postoperative pain relief/clinical or functional improvement?
2) In what percentage of the patients does core decompression achieve a cessation of radiological progression?
3) What percentage of patients undergoing core decompression without augmentation, ultimately require a THR?
4) What is the average time to requiring a THR following core decompression?
Figshare: PRISMA-P checklist for ‘What are the outcomes of core decompression in patients with avascular necrosis? Protocol for a systematic review’, https://doi.org/10.6084/m9.figshare.11720289.v319.
VK (MD, MA, MSc, FRCS(Orth)) is a Consultant Orthopaedic Surgeon at Addenbrooke’s - Cambridge University Hospital, England, UK. VK is also an Associate Lecturer at the University of Cambridge and the Associate Editor at the Bone and Joint Journal. He is also the Chair of SICOT Education Academy and Chair of the UK’s non-arthroplasty hip registry. OA (MD) is VK’s research fellow and orthopaedic surgery resident at the Balgrist University Hospital in Zurich, Switzerland. OW (MD) is VK’s research fellow and orthopaedic surgery resident at the Meir Medical Center, Kfar-Saba, Israel. HS (MD, DIC, MPH) is also VK’s research fellow and a Global Surgery Research Fellow at Harvard Medical School, Boston, MA, USA.
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Is the rationale for, and objectives of, the study clearly described?
Yes
Is the study design appropriate for the research question?
Yes
Are sufficient details of the methods provided to allow replication by others?
Yes
Are the datasets clearly presented in a useable and accessible format?
Yes
References
1. Schneider W, Breitenseher M, Engel A, Knahr K, et al.: [The value of core decompression in treatment of femur head necrosis].Orthopade. 2000; 29 (5): 420-9 PubMed Abstract | Publisher Full TextCompeting Interests: No competing interests were disclosed.
Reviewer Expertise: Orthopaedic surgery, osteoporosis, femoral head necrosis.
Is the rationale for, and objectives of, the study clearly described?
Yes
Is the study design appropriate for the research question?
Yes
Are sufficient details of the methods provided to allow replication by others?
Yes
Are the datasets clearly presented in a useable and accessible format?
Yes
References
1. Atilla B, Bakırcıoğlu S, Shope AJ, Parvızı J: Joint-preserving procedures for osteonecrosis of the femoral head.EFORT Open Rev. 2019; 4 (12): 647-658 PubMed Abstract | Publisher Full TextCompeting Interests: No competing interests were disclosed.
Reviewer Expertise: Hip preservation surgery, including arthroscopic and open hip procedures.
Alongside their report, reviewers assign a status to the article:
Invited Reviewers | ||
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Version 1 31 Jan 20 |
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Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. Consider the following examples, but note that this is not an exhaustive list:
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