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A scoping review of biomechanical testing for proximal humerus fracture implants Cruickshank, David; Lefaivre, Kelly A; Johal, Herman; MacIntyre, Norma J; Sprague, Sheila A; Scott, Taryn; Guy, Pierre; Cripton, Peter A; McKee, Michael; Bhandari, Mohit; Slobogean, Gerard P Jul 30, 2015

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RESEARCH ARTICLE Open AccessA scoping review of biomechanical testingfor proximal humerus fracture implantsDavid Cruickshank1, Kelly A. Lefaivre1, Herman Johal3, Norma J. MacIntyre2, Sheila A. Sprague3,4, Taryn Scott4,Pierre Guy1, Peter A. Cripton5, Michael McKee6, Mohit Bhandari3,4 and Gerard P. Slobogean3,7*AbstractBackground: Fixation failure is a relatively common sequela of surgical management of proximal humerus fractures(PHF). The purpose of this study is to understand the current state of the literature with regard to thebiomechanical testing of proximal humerus fracture implants.Methods: A scoping review of the proximal humerus fracture literature was performed, and studies testing themechanical properties of a PHF treatment were included in this review. Descriptive statistics were used tosummarize the characteristics and methods of the included studies.Results: 1,051 proximal humerus fracture studies were reviewed; 67 studies met our inclusion criteria. The mostcommon specimen used was cadaver bone (87 %), followed by sawbones (7 %) and animal bones (4 %). A two-part fracture pattern was tested most frequently (68 %), followed by three-part (23 %), and four-part (8 %). Implantstested included locking plates (52 %), intramedullary devices (25 %), and non-locking plates (25 %). Hemi-arthroplasty was tested in 5 studies (7 %), with no studies using reverse total shoulder arthroplasty (RTSA) implants.Torque was the most common mode of force applied (51 %), followed by axial loading (45 %), and cantileverbending (34 %). Substantial testing diversity was observed across all studies.Conclusions: The biomechanical literature was found to be both diverse and heterogeneous. More complexfracture patterns and RTSA implants have not been adequately tested. These gaps in the current literature will needto be addressed to ensure that future biomechanical research is clinically relevant and capable of improving theoutcomes of challenging proximal humerus fracture patterns.Keywords: Proximal humerus fracture, Biomechanics, Proximal humerus fracture implantBackgroundProximal humerus fractures (PHF) are a challenging in-jury in need of more reliable surgical techniques and im-proved health-related outcomes. Intra-articular screwpenetration, loss of reduction, and fracture healing com-plications frequently occur and have limited the successof surgical management [1]. Furthermore, the outcomesassociated with three- and four-part fracture patterns areoften both unpredictable and worse than anticipated [1–8]. The complications and long recovery times for PHFshave a significant impact on patient quality of life [4, 5,9] and the health care system [10].Biomechanical modeling provides controlled testingdata to support new surgical implants and novel treat-ment strategies. Biomechanical research is an importantmethod of evaluating orthopaedic implants as it removespatient factors and focuses on the performance of theimplant under strict testing conditions. There has beenan increasing focus on biomechanical modeling to testthe properties and limits of various techniques and im-plants used to treat proximal humerus fractures. Sincethere are numerous surgical implants and PHF patternsthat could be tested, the biomechanical literature is po-tentially a broad landscape of diverse research that hasnot been previously summarized.* Correspondence: gslobogean@umoa.umm.edu3Division of Orthopaedic Surgery, Department of Surgery, McMasterUniversity, Hamilton, Ontario, Canada7Department of Orthopaedics, University of Maryland School of Medicine,Baltimore, Maryland, USAFull list of author information is available at the end of the article© 2015 Cruickshank et al. This is an Open Access article distributed under the terms of the Creative Commons AttributionLicense (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in anymedium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Cruickshank et al. BMC Musculoskeletal Disorders  (2015) 16:175 DOI 10.1186/s12891-015-0627-xThe purpose of the current study was to: 1) use scop-ing review techniques [11, 12] to systematically evaluateand map the breadth of proximal humerus fracture bio-mechanical testing literature; 2) to summarize the modeldesigns and testing procedures most commonly employed;and, 3) to identify biomechanical areas that are not wellrepresented in the existing literature.MethodsLiterature searchAs part of our larger proximal humerus fracture scopingreview (Slobogean et al., [13]), we completed a compre-hensive literature search to identify studies on the man-agement of proximal humerus fractures. In consultationwith a biomedical librarian, we developed a sensitivesearch strategy to identify all types of publications in-volving proximal humerus fractures. Using a combin-ation of keywords and medical subject heading (MeSH)terms related to proximal humerus fractures, we searchedthe following electronic databases: Medline, ExcerptaMedica Database (EMBASE), Cumulative Index of Nurs-ing and Allied Health Literature (CINAHL), CochraneDatabase of Systematic Reviews (CDSR), Proquest, Webof Science, Society of Automotive Engineers (SAE) digitallibrary, and Transportation Research Board’s TransportResearch International Documentation (TRID) database.All searches were performed in October 2012, and no lan-guage or date restrictions were employed.Study selectionAll identified titles were then compiled into a literaturereview program (DistillerSR), and an independent reviewprocess was performed. All studies were reviewed in du-plicate by two orthopaedic surgeons, and studies involv-ing biomechanics were identified. We excluded reviewarticles, computer modeling, finite element analysisstudies, and studies that were not published in English.Data abstractionTwo authors (DC and TS) independently abstracted datafrom each included study focusing on the characteristicsof the analysis and the methods utilized to better under-stand the layout of the literature. Any disagreements onthe data abstracted were resolved by consensus in con-sultation with a third author (GPS). Study characteristicsabstracted included publication year, geographic loca-tion, sample size, and type of specimen. Methods dataabstraction examined pretesting analysis, implant selec-tion, and testing conditions.Statistical analysisDescriptive statistics were used to summarize all data.For continuous data, the mean and standard deviationor median and ranges were reported based on the data’sdistribution. Counts and proportions were used to de-scribe all other data. No inferential statistical testing wasperformed.ResultsLiterature reviewThe initial literature search of the PHF literature, whichincluded clinical and basic science studies, resulted inidentification of 5,406 titles. 2,540 were found to be du-plicates, seven were book titles, and two were retractedstudies; these were all excluded. An additional 1,459 ti-tles were removed because they did not meet the eligibil-ity criteria. After review, 1,051 proximal humerusfracture studies were included in our database. From oureligible PHF database, 94 were identified as basic scienceor biomechanical papers. For the purpose of this study,we excluded an additional 16 non-English language publi-cations, seven basic science articles, three finite elementanalysis studies, and one review article (Fig. 1). Therefore,67 proximal humerus biomechanical published studieswere included in the current analysis (Additional file 1).Study characteristicsThe majority of the included publications originatedfrom Europe (48 %) to North America (39 %), compris-ing 87 % of the total studies. Few biomechanical studieshave been published from Asia (4 %), South/CentralAmerica (3 %), to the Middle East (3 %) (Fig. 2). Theearliest included study identified dates back to 1988 withnothing published again until 1993. Since that time,however, there has been an exponential increase in bio-mechanical publications, with 13 studies published in2012 alone (Fig. 3).Specimen characteristicsThe sample size was reported in every study and theaverage sample size was found to be 27 ± 28.9 specimenswith a range of 5 to 150 specimens (Table 1). The mostcommonly tested specimen was cadaver bones (87 %)followed by saw bones (7 %), animal bones (4 %), andwood (1 %). Of the cadaver studies, the obtained ca-davers were frozen in 45 studies (75 %), embalmed in 12(20 %), and fresh in 3 (5 %). Of the 58 studies that usedcadaver specimens, only 33 (57 %) included informationon the age of the cadavers used. In the studies that re-ported age of the cadaver, the average age was found tobe 73.3 ± 8.5 years, with a range of 32 to 101 years ofage. Only 45 studies (67 %) undertook some form ofpre-testing investigations including plain radiographs (32studies), bone mineral density testing (31 studies), andCT scans (12 studies) (Table 2).Sixty studies tested proximal humerus fracture im-plants in a specific simulated fracture pattern. The mostcommon fracture simulated was a two-part proximalCruickshank et al. BMC Musculoskeletal Disorders  (2015) 16:175 Page 2 of 7humerus fracture in 41 studies (68 %), followed by athree-part fracture in 14 studies (23 %), and a four-part fracture in five studies (8 %) (Table 1). Of thetwo-part fracture simulations, 37 involved the surgicalneck, three involved the anatomic neck, and onestudy described making a two-part fracture model,but the location of the osteotomy was not stated.None of the included studies examined fractures ofthe greater tuberosity.The most common method of specimen preparationwas to create the fracture using a saw, followed by re-duction and fixation with the specified construct. Often,in order to simulate medial comminution, a section ofbone would be removed and a gap created. This modifi-cation of the specimen ensured that reduction and align-ment was maintained solely by the implant in theabsence of a medial cortical support. This was per-formed in 35 studies. When compared to fracture type,medial comminution was simulated in 27 (66 %) of thetwo-part fracture studies, in seven (50 %) of the three-part fracture studies and in none of the four-part frac-ture studies. One study specified that a gap osteotomywas performed but did not specify the location or thefracture pattern.Fig. 1 Search and screening flow chartCruickshank et al. BMC Musculoskeletal Disorders  (2015) 16:175 Page 3 of 7Implants evaluatedThe most frequently tested implant was a fixed anglelocking plate, which was tested in 35 studies (Fig. 4).Intramedullary devices, including intramedullary nails,were tested in 17 studies, followed by non-locking platesin 13 studies, and blade plates in eight studies. Interest-ingly, arthroplasty implants were only tested in five stud-ies and only included hemi-arthroplasty implants. Wedid not identify any studies that focused on biomechan-ical testing of total shoulder implants or reverse totalshoulder implants for the treatment of proximal hu-merus fractures. An overview of the implants evaluatedin each study is found in Additional file 2.Construct testingThe apparatus and testing procedure of the constructswas found to be highly heterogeneous between studiesand many different testing platforms, configurations,and devices were described in the included studies. Des-pite this heterogeneity, the majority of the studies testedtheir constructs under similar biomechanical themes,which has allowed us to summarize them. Specifically,the most commonly tested force was torque (34 studies),followed by axial load (30 studies), and cantilever bend-ing, usually in varus or valgus (23 studies) (Table 2).The testing parameters including the magnitude of theforce (20 studies), how the force was applied (64 stud-ies), and the loading mode (54 studies); all testing pa-rameters varied significantly between studies (Table 2).Fig. 2 Location of researchFig. 3 Frequency of studies published per yearTable 1 Specimen characteristicsCharacteristic FrequencyN (%)Type of Specimen (n = 67)Cadaver 58 (87)Saw Bones 5 (7)Animal 3 (4)Wood 1 (1)Cadaver State (n = 58)Frozen 44 (76)Embalmed 11 (19)Fresh 3 (5)Fracture Pattern (n = 60)2-part 41 (68)3-part 14 (23)4-part 5 (8)Cadaver Age (Mean ± Standard Deviation) 73 ± 8.5Number of specimens (Mean ± Standard Deviation) 27 ± 28.9Cruickshank et al. BMC Musculoskeletal Disorders  (2015) 16:175 Page 4 of 7Cyclic loading was utilized in 33 studies, load to failurewas used in 28 studies, and compounding cyclic load tofailure was used in six studies. In the studies that usedcyclic loading to test the construct, the number of cyclesvaried from 5 to 1,000,000; the most commonly usednumber of cycles was 1000 (seven studies). Many studies(34 studies) used a combination of testing modes, for ex-ample a construct would be put through cyclic loadingto a set number of cycles and then undergo a load tofailure test.Supplementary fixation methods were infrequentlyevaluated in the biomechanics literature. Sutures wereused to augment fixation in three studies; two of thestudies tested hemi-arthroplasty implants and one studytested locking plates. Tension band wiring, either on itsown or as an augment to a construct, was used in fourstudies. Bone grafting with structural grafts was tested inthree studies and two studies examined the use of ce-ment as an augment.DiscussionThe literature describing the biomechanical testing ofproximal humerus fracture implants is broad and het-erogeneous. It is evident that biomechanical testing isbeing performed more frequently to compare proximalhumerus fracture treatments; however, significant limita-tions to the clinical utility of the current testing modelsexist. These include a lack of models for three- andfour-part fractures and a high variability in the testingparameters utilized.The most common model identified was the simulatedtwo-part fracture. From a practical perspective, this isnot surprising since the fracture (osteotomy) occurs inthe surgical neck region and does not require the inves-tigator to recreate fractured tuberosity fragments or im-paction of the humeral head. Two-part fractures are alsoappealing to model because fixation is easily achieved inthe humeral head and shaft, and mechanical testing canfocus on axial, bending, and torsional loads across a sin-gle fracture line. Despite the study design advantages offocusing on two-part fractures, it is our opinion thatthree- and four-part fractures represent the true surgicalchallenge and should be the focus of most biomechan-ical testing [7, 8]. Fourteen studies simulated a three-Table 2 Testing characteristicsCharacteristic FrequencyN (%)(n = 67)Pre-Testing InvestigationsPlain radiographs 32 (48)Bone mineral density testing 31 (46)CT scans 12 (18)Testing ConstructsTorque 34 (51)Axial load 30 (45)Cantilever bending 23 (34)Testing ParametersHow the force was applied 64 (96)Loading mode 54 (81)Magnitude of force 20 (30)LoadingCyclic loading 33 (49)Load to failure 28 (42)Compounding cyclic load to failure 6 (9)Fig. 4 Frequency of implant testingCruickshank et al. BMC Musculoskeletal Disorders  (2015) 16:175 Page 5 of 7part fracture, and only five studies used a four-partmodel.Another key finding of our scoping review was thesubstantial heterogeneity in testing parameters. Wefound almost no duplication of testing configurationsand minimal standardization, which would allow com-parison between studies. Consequently, we classified thestudies based on biomechanical testing themes such asdirection of force and testing mode. In most studies, thedirection of force could be placed into one of three cat-egories: torque, axial load, or cantilever bending (varusor valgus). In addition to variations in the direction offorce applied, a wide range of force magnitude and cy-cles were observed. For example, 33 studies used cyclicloading to test their constructs; however, the number ofloading cycles used in each study ranged from 5 to1,000,000 cycles. Furthermore, in many of these studiesthe magnitude of the force applied was not reported, orthere was a wide variety in combinations of forces.Similar heterogeneity was also observed in the report-ing of cadaveric specimens used. Authors commonly didnot report the age of the specimens or the pre-testinganalysis conducted to ensure the validity of results. Only57 % of studies reported the age of the specimens and67 % reported their pre-testing analysis. Specifically,fewer than half of the studies reported the bone mineraldensity of their specimens, which is essential for ensur-ing testing specimens are comparable and the resultscan be interpreted within the context of other publishedstudies.The final gap identified in our scoping review was thelack of biomechanical testing of arthroplasty implants inproximal humerus fracture models. Although there arelikely many studies that test the mechanical propertiesof shoulder arthroplasty implants in an intact humerus,only five studies were identified that performed testingwithin a PHF model. This lack of relevant testing is im-portant to recognize because the implantation of a hu-meral arthroplasty stem in the setting of a proximalhumerus fracture is technically challenging and inher-ently unstable due the displacement of the tuberosityfragments. Furthermore, given the exponential increasein reverse total shoulder arthroplasty for PHF patients,relevant biomechanical testing would provide invaluableinformation to help guide treatment decisions [2].ConclusionThe primary strength of this scoping review is the abilityto identify key development areas to improve the qualityand relevance of biomechanical modeling for proximalhumerus fracture treatments. Our results suggest astrong need for implant testing in three- and four-partfracture models, testing of shoulder arthroplasty pros-theses in a PHF model, and standardization of testingparameters to ensure results can be compared betweenstudies. We anticipate this review will serve as spring-board for designing studies aiming to address these keygaps in the future application of biomechanical testingfor proximal humerus fracture treatments.Additional filesAdditional file 1: Studies included in the analysis. (DOCX 28 kb)Additional file 2: Implants tested in each included study. (XLSX 46 kb)AbbreviationsCDSR: Cochrane database of systematic reviews; CINAHL: Cumulative Indexof Nursing and Allied Health Literature; EMBASE: Excerpta medica database;IQR: Interquartile range; MeSH: Medical subject heading; PHF: Proximalhumerus fracture; RTSA: Reverse total shoulder arthroplasty; SAE: Society ofAutomotive Engineers; TRID: Transport research international documentation.Competing interestsThe authors declare that they have no competing interests.Authors’ contributionsDC participated in acquisition and interpretation of data and participated inmanuscript review and critical appraisal and revision. KAL participated inacquisition and interpretation of data and participated in manuscript reviewand critical appraisal and revision. HJ participated in the acquisition andinterpretation of data and participated manuscript review and criticalappraisal and revision. NJM participated in the interpretation of data and inmanuscript review and critical appraisal and revision. SAS participated inproject design and coordination and helped to draft the manuscript. TSparticipated in the gathering and analysis of data and helped to draft themanuscript. PG participated in the interpretation of the data with regard toclinical relevance in orthopaedic surgery and participated in manuscriptreview and critical appraisal and revision. PAC participated in theinterpretation of the data with regard to relevance in biomechanics andparticipated in manuscript review and critical appraisal and revision. MMparticipated in the interpretation of the data with regard to clinical relevancein orthopaedic surgery and participated in manuscript review and criticalappraisal and revision. MB participated in project design and participated inmanuscript review and critical appraisal and revision. GPS conceived theproject and participated in its design, the interpretation and analysis of data,and manuscript review and critical appraisal and revision. All authors readand approved the final manuscript.AcknowledgementsThe authors would like to acknowledge Dean Giustini for his assistance withthe literature search; Dawn Richards and Ravi Jain for their contributions asknowledge users; and Mikyla Grau, Manraj Chahal, Katherine Dmetrichuk, andVictoria Zuk for assistance with project coordination.This study was coordinated at McMaster University and funded by a researchgrant from the Canadian Institutes of Health Research (Grant Number:124598). The funding source had no role in the study design, data collection,dada analysis, interpretation of the data, writing of the manuscript, or thedecision to submit the article for publication.Author details1Department of Orthopaedics, University of British Columbia, Centre for HipHealth & Mobility, Robert H.N. Ho Research Centre, 771 - 2635 Laurel Street,Vancouver, BC V5Z 1 M9, Canada. 2School of Rehabilitation Science,McMaster University, Hamilton, Ontario, Canada. 3Division of OrthopaedicSurgery, Department of Surgery, McMaster University, Hamilton, Ontario,Canada. 4Department of Clinical Epidemiology and Biostatistics, McMasterUniversity, Hamilton, Ontario, Canada. 5Department of MechanicalEngineering, University of British Columbia, Vancouver, British Columbia,Canada. 6Division of Orthopaedic Surgery, Department of Surgery, Universityof Toronto, Toronto, Ontario, Canada. 7Department of Orthopaedics,University of Maryland School of Medicine, Baltimore, Maryland, USA.Cruickshank et al. BMC Musculoskeletal Disorders  (2015) 16:175 Page 6 of 7Received: 25 November 2014 Accepted: 13 July 2015References1. Jost B, Spross C, Grehn H, Gerber C. Locking place fixation of fractures ofthe proximal humerus: analysis of complications, revision strategies, andoutcome. 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Epidemiology of humerus fractures in theUnited States nationwide emergency department sample 2008. ArthritisCare Res. 2012;64:407–14. doi:10.1002/acr.21563.11. Levac D, Colquhoun H, O’Brien KK. Scoping studies: advancing themethodology. Implement Sci. 2010;5:69. doi:10.1186/1748-5908-5-69.12. McColl MA, Shortt S, Godwin M, Smith K, Rowe K, O’Brien P, et al. Modelsfor integrating rehabilitation and primary care: a scoping study. Arch PhysMed Rehabil. 2009;90:1523–31. doi:10.1016/j.apmr.2009.03.017.13. Slobogean GP, Johal H, Lefaivre K, MacIntyre NJ, Sprague SA, Scott T, et. al.A scoping review of the proximal humerus fracture literature. BMCMusculoskelet Disord. 2015;16(1):112Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color figure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submitCruickshank et al. BMC Musculoskeletal Disorders  (2015) 16:175 Page 7 of 7


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