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Contents lists available at ScienceDirect

Injury journal homepage: www.elsevier.com/locate/injury

Biomechanical studies: Science (f)or common sense? Jos J. Mellema a, Job N. Doornberg b, Thierry G. Guitton b, David Ring a,* Science of Variation Group1 a b

Orthopaedic Hand and Upper Extremity Service, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA University of Amsterdam Orthopaedic Residency Program (PGY 4), Academic Medical Center, Amsterdam, The Netherlands

A R T I C L E I N F O

A B S T R A C T

Article history: Accepted 14 September 2014

Introduction: It is our impression that many biomechanical studies invest substantial resources studying the obvious: that more and larger metal is stronger. The purpose of this study is to evaluate if a subset of biomechanical studies comparing fixation constructs just document common sense. Methods: Using a web-based survey, 274 orthopaedic surgeons and 81 medical students predicted the results of 11 biomechanical studies comparing fracture fixation constructs (selected based on the authors’ sense that the answer was obvious prior to performing the study). Sensitivity, specificity, and accuracy were calculated according to standard formulas. The agreement among the observers was calculated by using a multirater kappa, described by Siegel and Castellan. Results: The accuracy of predicting outcomes was 80% or greater for 10 of 11 studies. Accuracy was not influenced by level of experience (i.e., time in practice and medical students vs. surgeons). There were substantial differences in accuracy between observers from different regions. The overall categorical rating of inter-observer reliability according to Landis and Koch was moderate (k = 0.55; standard error (SE) = 0.01). Conclusion: The results of a subset of biomechanical studies comparing fracture fixation constructs can be predicted prior to doing the study. As these studies are time and resource intensive, one criterion for proceeding with a biomechanical study should be that the answer is not simply a matter of common sense. ß 2014 Elsevier Ltd. All rights reserved.

Keywords: Biomechanical Orthopaedic Fracture Fixation

Introduction It is our impression that many biomechanical studies [1–22] invest substantial resources studying the obvious: that more and larger metal is stronger. Studies that evaluate ‘‘which construct is the strongest’’ distract from the more important question: ‘‘How strong is strong enough in physiological loading conditions?’’. The purpose of this study is to evaluate if some biomechanical studies comparing fixation constructs just document common sense. If so, there is a need for more careful use of resources in the lab and better collaboration with surgeons to enhance clinical relevance. This study tested our hypothesis that a subset of biomechanical studies comparing fracture fixation constructs can be predicted based on common sense and do not require formal testing. Specifically our primary hypothesis was that outcomes of

* Corresponding author. Tel.: +1 617 643 7527; fax: +1 617 726 0460. E-mail address: [email protected] (D. Ring). 1 The members of Science of Variation Group are listed in Appendix.

some biomechanical studies comparing fracture fixation constructs are predictable with high accuracy. Our secondary hypotheses addressed inter-observer reliability and accuracy according to experience and other factors. Methods Between 2000 and 2012, we found 105 peer-reviewed biomechanical studies in peer-reviewed orthopaedic journals comparing two or more constructs in order to determine: ‘‘Which construct is the strongest?’’. We excluded six studies of spine, skull, and facial fractures. From the remaining 99 studies, 12 had a good illustration of the constructs. Among those 12 studies, we selected 11 for which we thought the answer was obvious prior to performing the study [2,7–9,11,12,14,15,19,21,23]. Orthopaedic and trauma surgeons affiliated with the Science of Variation Group (SOVG) and medical students from the University of Amsterdam were invited to predict the outcome of biomechanical studies comparing different fixation constructs. As many as 275 surgeons who treat musculoskeletal trauma and 81 medical

http://dx.doi.org/10.1016/j.injury.2014.09.014 0020–1383/ß 2014 Elsevier Ltd. All rights reserved.

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Fig. 1. Percutaneous pins versus volar plates for unstable distal radius fractures: a biomechanic study using a cadaver model [11].

students were interested in participating logged on to the website; 274 of these 275 surgeons (99.6%) and 81 of 81 students (100%), completed the study. The Institutional Research Board at the principal investigator’s hospital provided a waiver for the study protocol. All studies were selected and blinded by independent research fellows (JJM and JND) for use in this study. The blinded experimental designs were uploaded to the website. Upon login to the website, observers received a short descriptive summary of the study purpose. Observers were asked to answer one question: ‘‘Which construct is stronger?’’ based on provided illustrations that were copy-pasted from the original articles without manipulation.

No figure legends or explanatory text accompanied the illustrations. The outcome had to be predicted based on visual information judging the experimental test set-up only (Figs. 1 and 2). Observers could comment on each study. Every question had to be completed in order to continue with the next case. The observers completed the study at their own pace. The result of the original study was considered the reference standard. Sensitivity, specificity, accuracy, positive predictive value, and the negative predictive value were calculated to standard formulas. The agreement among the observers was calculated by using a multirater kappa, described by Siegel and Castellan [24]. It is a

Fig. 2. Biomechanical evaluation of proximal humeral fracture fixation supplemented with calcium phosphate cement [12].

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commonly used statistic to describe chance-corrected agreement in a variety of intra-observer and inter-observer studies [25– 27]. The kappa values were interpreted by using the categorical rating that was proposed by Landis and Koch [26]: values of 0.01– 0.20 indicated slight agreement; 0.21–0.40 indicated fair agreement; 0.41–0.60, moderate agreement; 0.61–0.80, substantial agreement; and a value that was >0.81 indicated almost perfect agreement. Zero indicated that there was no agreement beyond what was expected due to chance alone. The value of 1.00 meant total disagreement and +1.00 represented perfect agreement [26,27]. We used previously described methods for evaluating the significance of differences between kappa values [28]. Results Accuracy was 80% or greater for 10 of 11 studies that have been predicted by members of the SOVG (Table 1). The diagnostic performance characteristics for guessing the results of the study were as follows: sensitivity averaged 84%, ranging from 60% (for study 1) to 99% (for study 7); specificity 86%, ranging from 60% (for study 1) to 99% (for study 7), and accuracy averaged 86%, ranging from 60% (for study 1) to 99% (for study 7). Study 5 was predicted with the highest accuracy (accuracy 97% and 98% for members of the SOVG and medical students, respectively) (Fig. 1), and study 1 was predicted with least accuracy (accuracy 61% and 60% for members of the SOVG and medical students, respectively) (Fig. 2). The level of experience (i.e., time in practice and medical students vs. surgeons) had no influence on accuracy (Tables 1 and 2). There were substantial differences in accuracy between Canadians and observers from other regions (p < 0.05). Canadian observers predicted with the highest accuracy (accuracy 94%, range 58–100%). The average accuracy in the American observer group was 88% (range 57–97%) compared with 84% (range 69–99%) in the European observer group (p < 0.05). The overall categorical rating of inter-observer reliability according to Landis and Koch was moderate (k = 0.55; SE = 0.01), ranging from k = 0.33 (SE = 0.06) to k = 0.82 (SE = 0.03) (Table 2). Analyses of SOVG subgroups identified excellent agreement among Canadian surgeons. Moderate and substantial agreement were found in most of other subgroups: ranging from moderate (k = 0.48; SE = 0.01) among specialists 21 years or more in practice to moderate (k = 0.59; SE = 0.01) among specialists 11–20 years in practice; and moderate, ranging from k = 0.47 (SE = 0.06) to k = 0.60 (SE = 0.01), among specialists who practice in Australia, Europe, and United States. There was no significant difference in kappa value between SOVG members and Table 1 Accuracy and agreement for predicting outcome of biomechanical studies selected. Members SOVG (accuracy)

Members SOVG (% agreementa)

Study (Experimental test set-up) 1 0.61 61 2 0.80 60 3 0.93 93 4 0.89 89 5 0.97 97 6 0.90 90 7 0.84 84 8 0.93 93 9 0.80 80 10 0.90 90 11 0.89 89 Average a

100.

0.86

84

Medical students (accuracy)

Medical students (% agreementa)

0.60 0.87 0.93 0.84 0.98 0.90 0.99 0.93 0.79 0.74 0.91

60 74 93 84 98 90 99 93 79 74 91

0.86

85

% Agreement, number of agreements/(number of agreements + disagreements) 

3

Table 2 Observer demographics, accuracy, and kappa values.

Members SOVG Observers’ gender Male Female Practice Asia Australia Canada Europe United Kingdom United States Other Years in practice 0–5 6–10 11–20 21–30 Specialization General orthopaedics Orthopaedic traumatology Shoulder and elbow Hand and wrist Other

N

%

Kappa (SE)a

% Accuracy (95% CI)

252 22

92.0 8.0

0.55 (0.01) 0.45 (0.02)

86 (85–87) 82 (79–85)

11 6 12 68 6 146 25

4.0 2.2 4.4 24.8 2.2 53.3 9.1

0.36 0.47 0.82 0.51 0.33 0.60 0.42

(0.03) (0.06) (0.03) (0.01) (0.06) (0.01) (0.02)

80 81 94 84 82 88 82

(75–85) (75–87) (91–97) (82–86) (76–88) (87–89) (79–85)

94 60 75 45

34.3 21.9 27.4 16.4

0.54 0.50 0.59 0.48

(0.01) (0.01) (0.01) (0.01)

86 85 86 84

(84–88) (83–87) (84–88) (82–86)

16 96 41 107 14

5.8 35.0 15.0 39.1 5.1

0.33 0.53 0.58 0.60 0.42

(0.02) (0.01) (0.01) (0.01) (0.02)

81 84 88 86 85

(77–85) (83–85) (86–90) (85–87) (81–89)

32 14 35

39.5 17.3 43.2

0.55 (0.01) 0.60 (0.03) 0.54 (0.01)

Medical students Years of study 1–2 3–4 5–6 a

86 (84–88) 86 (82–90) 86 (84–88)

Overall kappa = 0.55; SE, 0.01.

medical students (k = 0.54; SE = 0.01 and k = 0.56; SE = 0.01, respectively); the difference was judged not to be significant as 95% confidence interval did overlap.

Discussion This study confirms our hypothesis that outcomes of a subset of biomechanical studies – comparing fixation constructs – are quite predictable as accuracy was at least 80% for all but one study. In addition, the secondary null hypothesis that the experience of observers has no influence on the accuracy of predicting outcomes was not rejected because medical students and experienced surgeons performed equally well. In other words, it seems that some comparative biomechanical studies just confirm common sense. The important thing is not ‘‘which construct is strongest?’’ – because it seems obvious that more metal is stronger – but rather ‘‘how strong is strong enough?’’ given that larger and stronger constructs might be too prominent or bulky. In other words, what is the best treatment option when one considers all the advantages and disadvantages? For example, Hutchinson and colleagues evaluated four types of olecranon fixation techniques for simple transverse fractures [9]. The fixation type with the most metal (a 7.3-mm cancellous crew combined with a tension-band construct) provided the most stable fixation. Fixation techniques with less metal, that is, (a) intramedullary or (b) transcortical K-wires with an 18-gauge tension band, or (c) 7.3 mm cancellous screws without tension band wiring, were less strong. These results seem predictable and the clinical relevance unclear given that the smaller tension band wire fixation has a good track record [29,30]. A second example is the study by Markolf and colleagues. The authors analyzed the effect of radial head replacement on elbow joint stability after fracture–dislocation [31]. It is no surprise that the largest radial head tightens the ligaments more, but this does not account for the clinical problem of ‘‘overstuffing’’ the radiocapitellar

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joint [32,33]. In other words, the best biomechanical construct is not as good for patients. We acknowledge inherent weaknesses of this study. First, there is the effect of deliberate selection bias for inclusion and exclusion of biomechanical studies presented. In a broad spectrum of biomechanical studies, only this subset of studies comparing fixation constructs, with proper illustration of the experimental test set-up in the original article, were selected based on our sense that the answer of the main study question was obvious prior to performing the study. Furthermore, we simplified the selected studies to a comparison of which construct was strongest, when these studies actually consisted of more sophisticated analyses of stiffness, strength to failure, and resistance to deformation. On the other hand, these variables amount to what orthopaedic surgeons would consider the ‘‘strength’’ of the implant. In our opinion, biomechanical studies should address adequate mechanics in relation to other important factors such as biology, risks, and costs rather than superior strength in a lab situation alone. Biomechanical aspects of fixation techniques are important, but should not be overemphasized. The rationale for using the ‘‘strongest’’ implant can be compelling to the human mind out of proportion to the overall safety, effectiveness, and resourcefulness of the implant. Conclusion According to our findings, a subset of biomechanical studies comparing fracture fixation constructs can be predicted prior to doing the study. As these studies are time and resource intensive, one criterion for proceeding with a biomechanical study should be that the answer is not simply a matter of common sense. Authors’ contributions All authors have participated in a material way to at least three of the five elements below: Study design: JJM, JND, TGG, DR. Gathered data: JJM, TGG. Analyzed data: JJM, JND, DR. Initial draft: JJM, JND, DR. Ensured accuracy of data: JJM, JND, TGG, DR. Estimated effort: JJM 50%, JND 20%, TGG 10%, DR 20%. Conflicts of interest The authors declare that there are no conflicts of interest.

Appendix. Science of Variation Group A.L. van der Zwan, A.B. Spoor, A.B. van Vugt, A.D. Armstrong, A. Shrivastava, A.L. Wahegaonkar, A.B. Shafritz, J. Adams, A. Ilyas, A.J.H. Vochteloo, A.P. Castillo, A. Basak, P. Andreas, A. Barquet, A. Kristan, A. Berner, A.B. Ranade, S. Ashish, A.L. Terrono, A. Jubel, B. Frieman, H.B. Bamberger, M.P J. van den Bekerom, W.D. Belangero, B.F. Hearon, J.M. Boler, F.L. Walter, M. Boyer, B.P.D. Wills, H. Broekhuyse, R. Buckley, B. Watkins, B.W. Sears, R.P. Calfee, C. Ekholm, C.H. Fernandes, C. Swigart, C. Cassidy, C.J. Wilson, L.C. Bainbridge, C. Wilson, C. M. Jones, C. Cornell, B.D. Crist, D.F.P. van Deurzen, D. Beingessner, D.J. Rowland, G.J. Della Rocca, D. Eygendaal, D.M. McKee, D.O.F. Verbeek, D.M. Kalainov, D. Polatsch, C.J.R. Barreto, M. Merchant, D. Brilej, N. Bijlani, D.M. Silva, E. Maman, I.M. Ibrahim, R. Nyszkiewicz, P.D.G. Henry, D. Ruchelsman, I.M. Vishwanath, D.F. Scott, E. Harvey, E. Grosso, E. Stojkovska Pemovska, E.T. Tolo, E.D. Schumer, F. Suarez, F. Frihagen, F. LopezGonzalez, F.M. Rodrı´guez, G.C. Zambrano Caro, C. Garnavos, G.S. Athwal, G. DeSilva, G.S.M. Dyer, G.C. Babis, G. Gradl, G.K. Frykman, R.G. Gaston, G. Garrigues, G.J. Bayne, G. Merrell, G.R. Hernandez, G.

Gadbled, L.A.B. Campinhos, G.W. Balfour, H. van der Heide, M. Nancollas, C. Young, G.M. Pess, H. Goost, H. Alonso, Villamizar, H. Awan, H.D. Routman, H.L. Kimball, E. Hofmeister, I. McGraw, K. Erol, J. Biert, J.C. Goslings, J.F. di Giovanni, J. Bishop, J.M. Abzug, J.A. Greenberg, J. Ahn, J. McAuliffe, J.C. Fanuele, J.G. Boretto, J. Choueka, J. Murachovsky, J. E.G. Ribeiro Filho, J. Isaacs, J.A. Izzi Jr., J. Kellam, J.L. Giuffre, J.M. Conflitti, J.M. Wolf, J.H. Scheer, J.T. Capo, J. Rubio, J. Taras, J. Wint, J. Wolkenfelt, S. Kakar, K. Chivers, K. Zyto, J.D. Keener, K. Eng, K. Jeray, K. Lee, K.J. Malone, K. Kabir, G.A. Kraan, K. Radcliff, K. Dickson, L.M.S.J. Poelhekke, L. Mica, L. Weiss, L.E. Adolfsson, L.C. Borris, N.G. Lasanianos, L.M. Schulte, L. Paz, N.E.L. Felipe, Verhofstad, M.A.J. van de Sande, M. Mormino, M.J. Richard, M. Bonczar, E.M. Hammerberg, M. Menon, A.D. Mazzocca, M.W.G.A. Bronkhorst, M. Mckee, M. Soong, R.M. Costanzo, M.M. Wood, M.I. Abdel-Ghany, M. Baskies, M. Behrman, M. Quell, M.W. Kessler, M.J. Palmer, M. Prayson, M. Pirpiris, M.M. Ragsdell, M.R. Krijnen, M. Tyllianakis, M.W. Grafe, N. Schep, E. Nelson, N.M. Akabudike, N.L. Shortt, N.J. Horangic, N.L. Leung, N.W. Gummerson, N.K. Kanakaris, N. Wilson, J. Calandruccio, O.M. Semenkin, R. Omid, C.J.H. Veillette, M. Richardson, J.A. Ortiz Jr., J.E. Forigua, P.R.G. Brink, P. Kloen, P.V. van Eerten, I. Prashanth, P. Althausen, P. Lygdas, N. Parnes, P.A. Martineau, P. Benhaim, P. Blazar, Schandelmaier, B. Petrisor, P. Jebson, P. Levin, W.A. Batson, F. Garcı´a, P.W. Owens, L. Guenter, R. Haverlag, R.W. Peters, R. de Bedout, R. Shatford, S. Rowinski, R.A.W. Verhagen, R.H. Babst, R. Hauck, R Papandrea, R.S. Gilbert, M. Rizzo, R. Jenkinson, R.L. Hutchison, R. Liem, R.M. Smith, R. Tashijan, R.D. Zura, R.S. Page, R. Pesantez, R. Wagenmakers, J. Abrams, S. Spruijt, S.A. Kennedy, S. Mehta, S. Beldner, A. Schmidt, S. Mitchell, S.T. Fischer, S.L. Checchia, S. Dodds, B.M. Nolan, S. Kaplan, S.G. Kaar, S. Kronlage, S.A. Meylaerts, S. Steinmann, S.J. McCabe, P.N. Streubel, T. Omara, M. Swiontkowski, T. Gosens, T. DeCoster, L. Taitsman, T. Baxamusa, T. Dienstknecht, F.T.D. Kaplan, T. Siff, T. Begue, T. Higgins, T. Mittlmeier, T. Apard, T. Hughes, T. Havlicˇek, T. Wyrick, Rozental, T.G. Stackhouse, V. Giordano, T.F. Varecka, V.S. Nikolaou, V. Jokhi, V. Philippe, C.J. Wall, C.J. Walsh, W.C. Hammert, Y. Weil, W. Satora, T. Wright, C. Zalavras.

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Biomechanical studies: science (f)or common sense?

It is our impression that many biomechanical studies invest substantial resources studying the obvious: that more and larger metal is stronger. The pu...
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