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SYSTEMATIC REVIEW PROTOCOLS

Effectiveness of operative interventions for hemi or total hip arthroplasty patients who sustain a Vancouver B2 peri-prosthetic femoral fracture: a systematic review protocol

Ianunzio, Jamie Raffaele1; Munn, Zachary1; Mandziak, Daniel2; Stephenson, Matthew1; Cain, Megan Elizabeth1

Author Information
JBI Database of Systematic Reviews and Implementation Reports: February 2017 - Volume 15 - Issue 2 - p 245-258
doi: 10.11124/JBISRIR-2016-002941
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Abstract

Background

Hip arthroplasty is a commonly performed orthopedic intervention employed in the management of various hip pathologies.1 Australian registry data indicate that over 42,000 hip arthroplasty procedures were performed during 2014, 75% of which were primary total hip arthroplasties (THAs) with osteoarthritis and neck of femur fracture the most common indications for surgery with an incidence of 88.5% and 4.1%, respectively.2 Furthermore, around 14% of these were hip hemi-arthroplasty procedures with neck of femur fracture being the indication for surgery in over 90% of cases.2 The American joint replacement registry reported that almost 83,000 hip arthroplasty procedures were performed during 2014, with similar proportions of primary THA and hip hemi-arthroplasty procedures to that of Australian data.3 In addition, the National Joint Registry for England and Wales reported that around 83,000 hip arthroplasty procedures were performed during 2014.4

Peri-prosthetic femoral fractures (PFF) around hip arthroplasties may occur intraoperatively or postoperatively, and although infrequent, are a significant complication imparting a heavy burden upon patient, orthopedic surgeon and the health care system.5,6 Postoperative PFFs usually occur during minor trauma with epidemiological studies revealing an incidence anywhere between 0.4% and 3.5% for primary THA and around 4% following revision THA.5,7-9 With regard to hip hemiarthroplasties, the incidence of PFF has been estimated between 2% and 4% for cementless implants and 0.5% and 1% for cemented implants.10,11 Intraoperative PFFs usually occur during femoral stem implantation and are classified differently to postoperative PFFs, and therefore will not be dealt with in our study.12

Peri-prosthetic femoral fracture (PFF) related mortality has been analyzed using data from the Swedish National Hip Registry in the THA population, with three main findings, including: (i) immediate postoperative and long-term mortality is higher in surgically managed PFF patients compared with the population undergoing primary THA; (ii) men and women at age 70 years with PFF had a 2.1% and 1.2% estimated probability, respectively, of a fatal outcome due to fracture; and (iii) men and women aged at 80 years had a 3.9% and 2.2% estimated probability, respectively.13 Furthermore, economic analysis of PFF management around hip arthroplasties raises an additional challenge for all stakeholders, with an average cost estimate of £23,469 per patient reported in the United Kingdom setting between 1999 and 2009.6

A multi-disciplinary approach is required for management of such fractures with both orthopedic traumatologists and arthroplasty surgeons fundamental in planning and execution of surgical intervention. The Vancouver classification system, devised by Brady et al.,14 is the most commonly utilized system for classifying peri-prosthetic fractures around hip arthroplasties. This classification system has been shown to be both reliable and valid.14,15 The system considers the site of fracture, stability of implant and quality of surrounding bone stock, which are collective pillars for management decision making. Type A fractures are confined to the greater or lesser trochanter. Type B fractures are diaphyseal, around the prosthesis or immediately distal to it, and are further classified into type B1, B2 and B3, characterized by a well-fixed stem, an unstable stem with sufficient bone stock and an unstable stem with poor quality bone stock, respectively. Type C is significantly distal to the prosthetic tip.

The Swedish National Hip Arthroplasty Registry data spanning 1979 to 2000 identified 1049 PFFs, with over half being Vancouver type B2 (52%).5 Vancouver type B2 fracture management recommendations are currently for long stem femoral stem revision arthroplasty, with or without internal fixation, with the aim of re-establishing implant stability and facilitating fracture healing.16,17 In most cases, revision femoral arthroplasty involves open surgical dislocation of the hip, removal of the loose femoral implant and exchange for an uncemented long stem prosthesis that bypasses the fracture site.17

Open reduction and internal fixation (ORIF) for Vancouver B2 fractures has not traditionally been recommended due to the non-union rates, prolonged immobilization periods and risk of further revision surgery being required for an unstable femoral implant.5,18 In contrast to revision, ORIF strategies generally attract a shorter operative time and involve surgical dissection to directly visualize the fracture site, anatomical reduction and subsequent internal fixation with plates, screws which are temporized with clamping tools and subsequently internally fixed with plate(s), screws or allografts, or a combination. Common fixation strategies include locking plates, compression plates, or cables with or without cortical strut allografts.19

At present, there is a modest amount of literature assessing the outcomes of Vancouver type B2 fracture management by way of ORIF and femoral revision with or without internal fixation. Our scoping search revealed approximately 1000 published cases of Vancouver type B2 fracture management in the literature, including case studies, case series and cohort studies. One study including 19 patients has shown promising results with ORIF management of select Vancouver B2 fractures around collarless cemented polished tapered (CCPT) stems.18 In addition, Joestl et al.20 have shown similar functional and radiographic outcomes with ORIF and revision arthroplasty in management of Vancouver B2 fractures.

If selected Vancouver type B2 fractures were shown to be amenable to ORIF alone rather than revision, it would be beneficial given that much intra-operative risk would be mitigated by way of shorter operative times, and a reduction in skill set demands upon the surgeon in implant costs, and allow for subsequent revision in arthroplasty in younger individuals.18 We searched the JBI Database of Systematic Reviews and Implementation Reports, Cochrane Database of Systematic Reviews and PubMed and found no recent systematic review on this topic (August 4, 2016). As such, a systematic review is required.

Inclusion and exclusion criteria

Types of participants

The current review will consider studies including individuals who have undergone a THA or hip hemiarthroplasty, primary or revision, who sustain a Vancouver type B2, or equivalent, PFF. Those sustaining intraoperative fractures will be excluded, since the classification system is different.

Types of interventions

This review will consider studies that evaluate the following:

  • Open reduction and internal fixation by any method including but not limited to, cable plate, compression plate, locking plates, screws, cerclage wires, cortical strut allografts OR a combination AND/OR.
  • Any form of femoral revision arthroplasty, with or without internal fixation.

The current review will aim to compare the aforementioned interventions with each other. Studies that have evaluated two or more interventions and studies that have investigated only a single intervention will be considered for inclusion. If any of the interventions are compared with a different approach, including nonoperative management, these will be considered for inclusion.

Outcomes

The current review will consider studies that include at least one of the outcomes listed below.

Outcomes and their measures include (Note: imaging including, but not limited to, plain film radiographs [X-ray], computed tomography [CT)] and magnetic resonance imaging [MRI] as well as clinical diagnosis may be used in identification of the outcomes listed):

  • Re-operation – defined as return to theatre for any surgical intervention required to manage the Vancouver Type B2 fracture OR complication following initial management strategy or other definition used by study authors.
  • Implant breakage/migration of screws – defined as fracture through any hardware component or migration of screws or other definition used by study authors.
  • Femoral loosening – as defined using Harris’ criteria21 or other criteria used by study authors.
  • Femoral osteolysis – defined as a greater than 3-mm sized nonlinear demarcated lesion18 or other definition used by study authors.
  • Stem subsidence/migration:
    • – “Stem subsidence (is) measured using the width of radio-lucent lines present at the s-c interface in Gruen zone 1 parallel to the stem long axis”18(p.171) or other measurement method used by study authors
    • – For CCPT femoral stems, <6-mm subsidence expected and acceptable18
    • – For other femoral stem systems, thresholds for acceptable subsidence will be based on relevant literature/expert opinion/product manufacturer guide
  • Union – defined clinically as absence of pain at fracture site upon weight-bearing and radiographically as cortical bridging of fracture on three or more sides viewed on anteroposterior and lateral radiograph18,20 or other definition used by study authors
  • Delayed union – defined as healing taking greater than three months from time of surgery20 or other definition used by study authors
  • Non-union – defined as a lack of progressive signs of healing beyond six months postoperatively20 or other definition used by study authors
  • Malunion – defined as deviation of more than five degrees from anatomical norms in the mediolateral or anterioposterior plains22 or other definition used by study authors
  • Re-fracture – defined as any new peri-prosthetic fracture or re-fracture through previous fracture site or other definition used by study authors
  • Loss of reduction – defined as any change in fracture alignment20 or other definition used by study authors
  • Dislocation of prosthesis – defined as loss of anatomical reduction at hip articulation or other definition used by study authors
  • Neurovascular injury – defined as any neurological or vascular deficit, permanent or temporary, attributed directly to management intervention as documented by surgical team (excluding effects of regional anesthesia) or other definition used by study authors
  • Prosthetic joint infection defined as the following23 (or other definition used by study authors):
    • – Sinus tract to prosthesis OR
    • – Culture pathogen from 2+ samples OR
    • – Four out of six of the following:
      • Elevated erythrocyte sedimentation rate and serum C-reactive protein concentration
      • Elevated synovial leukocyte count
      • Elevated synovial neutrophil percentage
      • Purulence in affected joint
      • Isolation of organism in one culture of peri-prosthetic tissue or fluid
      • More than five neutrophils per five high powered fields on analysis of peri-prosthetic tissue at ×400 magnification
  • Functional outcomes including, but not limited to:
    • – Harris hip score24 OR
    • – Oxford hip score25 OR
    • – University of California, Los Angeles activity score26 OR
    • – Parker mobility score27
  • Operative risks:
    • – Total operating room time
    • – Skin-to-skin surgical time
    • – Perioperative blood transfusion requirement
  • Deep vein thrombosis (DVT) – as diagnosed by ascending contrast venography or other diagnostic tool used by study authors
  • Pulmonary Embolism (PE) – as diagnosed by computed tomography pulmonary angiography (CTPA) or other diagnostic tool used by study authors
  • Length of stay in hospital
  • Mortality.

Types of studies

The current review will consider both experimental and observational study designs including randomized controlled trials, non-randomized controlled trials, quasi-experimental, before and after studies, prospective and retrospective cohort studies, case studies, case-control studies and analytical cross sectional studies for inclusion. Studies that include less than five patients with Vancouver type B2 PFFs will be excluded due to the expected number of studies for review.

Search strategy

The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilized in this review. An initial limited search of PubMed (MEDLINE) was undertaken using key words such as femoral fracture, peri-prosthetic and arthroplasty followed by analysis of the text words contained in the title and abstract and of the index terms used to describe article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Third, the reference list of all identified reports and articles will be searched for additional studies. Studies published in English will be considered for inclusion in this review. Articles published prior to 1990 will be excluded to ensure management strategies reflect current clinical practice. In addition, we will contact known experts in the field and prominent authors to enquire about their knowledge of any completed published or unpublished studies relevant to our objective.

The databases to be searched include as follows:

PubMed (MEDLINE), Embase, CINAHL, The Cochrane Central Register of Controlled Trials (CENTRAL) and Web of Science.

In addition, the following gray literature databases will be searched: ClinicalTrials.gov and Proquest Theses and Dissertations.

The PubMed Medline search strategy will be as follows:

Femoral fractures[mh] OR femoral fracture[tw] OR femur fracture[tw]

AND

Periprosthetic[tw] OR peri-prosthetic[tw] OR peri prosthetic[tw]

AND

Arthroplasty, replacement, hip[mh] OR hemiarthroplasty[mh] OR hip arthroplasty[tw] OR.

hip replacement[tw] OR hip hemiarthroplasty[tw].

Assessment of methodological quality

Quantitative papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the JBI (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion or with a third reviewer.

Data extraction

Data will be extracted from papers included in the review using the standardized data extraction tool from JBI-System for the Unified Management, Assessment and Review of Information (SUMARI) (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review objective and specific objectives. In the event of data of interest being absent in published article(s), raw data shall be requested via direct contact with corresponding author(s).

Data synthesis

Quantitative data will, where possible, be pooled in statistical meta-analysis using JBI-SUMARI and/or RevMan V5.3 (The Nordic Cochrane Centre, Cochrane; Copenhagen, Denmark). As we intend to generalize the results beyond the included studies, the random effects model meta-analysis will be chosen as the default model as this is a more appropriate approach than the fixed model for this purpose.28 The fixed effect meta-analysis model will be used only if it is not appropriate to use the random effects model (e.g. if less than five studies are included in meta-analysis).28 Data will be synthesized in meta-analysis and presented in forest plots. Effect sizes will be expressed as odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard chi-square and I2 and also explored using subgroup analyses based on the different study designs included in this review. Other subgroups planned include by age, sex, co-morbidities, smoking status, surgical expertise and intervention technique. Where synthesis in meta-analysis is not possible, due to significant clinical or methodological heterogeneity, we will provide a narrative description of the results including tables and figures to aid in data presentation where appropriate.

A Summary of Findings table will be created with the GRADEpro GDT [Software] (GRADEpro Guideline Development Tool, Hamilton, Ontario, Canada). The Grading of Recommendations Assessment, Development and Evaluation approach for grading the quality of evidence will be followed.29 The Summary of Findings table will present the following information where appropriate: absolute risks for the treatment and control, estimates of relative risk and a ranking of the quality of the evidence based on the risk of bias, directness, heterogeneity, precision and risk of publication bias of the review results.30

Appendix I: Appraisal instruments

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Appendix II: Data extraction instrument

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Acknowledgements

This review contributes toward a Master of Clinical Science, through The Joanna Briggs Institute, The University of Adelaide, Australia, for JRI.

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Keywords:

Femoral revision arthroplasty; open reduction internal fixation; periprosthetic fracture; unstable implant; vancouver type B2

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