functional outcome after mason ii-iv radial head and neck€¦ · radial head and neck fractures:...

For peer review only

Functional outcome after Mason II-IV radial head and neck

fractures: Study protocol for a systematic review in

accordance with the PRISMA statement

Journal: BMJ Open

Manuscript ID bmjopen-2016-013022

Article Type: Protocol

Date Submitted by the Author: 13-Jun-2016

Complete List of Authors: Hagelberg, Mårten; Karolinska Institutet Department of Clinical Sciences Danderyd Hospital, Thune, Alexandra; Karolinska Institutet, Department of clinical sciences at Danderyd hospital Sköldenberg, Olof; Karolinska Institutet, Department of clinical sciences at Danderyd hospital

Primary Subject Heading:

Surgery

Secondary Subject Heading: Emergency medicine

Keywords: Elbow & shoulder < ORTHOPAEDIC & TRAUMA SURGERY, Radial head and neck fractures, Systematic review protocol, Treatment outcome

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FunctionaloutcomeafterMasonII-IV

radialheadandneckfractures:Study

protocolforasystematicreviewin

accordancewiththePRISMAstatement

Mårten Hagelberg, MD, Alexandra Thune, MD, Olof Sköldenberg, MD, PhD, Assoc. Prof.

All at Karolinska Institutet, Department of Clinical Sciences at Danderyd Hospital, Stockholm,

Sweden.

Correspondence: Dr. Olof Sköldenberg, MD, PhD, Associate Professor, Department of Clinical

Sciences, Unit of Orthopaedics, Karolinska Institutet at Danderyd Hospital, S-182 88 Danderyd,

Sweden. Tel +46-8-6555000. Fax +46-8-7551476.

E-mail: [email protected]

Key words: Radial head and neck fractures, elbow joint, intervention, treatment outcome,

systematic review protocol.

Word count: 1619

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ABSTRACT

Introduction

Fractures of the radial head and neck are the most common fractures of the elbow, and account for

approximately one-third of all elbow fractures. Depending on the fracture type the treatment is

either conservative or surgical. There is no absolute consensus regarding optimal treatment for

different fracture types. The aim of this protocol is to present the method that will be used to collect,

describe and analyse the current evidence regarding the treatment of radial head and neck fractures.

Method and analysis

We will conduct a systematic review in accordance with the Preferred Reporting Items for Systematic

Review and Meta-Analysis Protocol guidelines (PRISMA-P) statement. We will search a number of

databases with a predefined search strategy to collect both randomized and non-randomized

studies. The articles will be summarized with descriptive statistics. If applicable a meta-analysis will

be conducted.

Ethics and dissemination

Ethical approval is not required since this is a protocol for a systematic review and no primary data

will be collected. The authors will publish findings from this review in a peer-reviewed scientific

journal.

Trial registration number

PROSPERO registration number: 2016:CRD42016037627

STRENGHTS AND LIMITATIONS

• A review on this subject has never to our knowledge been performed before according to

PRISMA standard.

• Very common injury with clinical significance for patients.

• No clear consensus regarding optimal treatment.

• There are few randomized controlled trials on the subject

• Heterogenic outcomes and methods across the literature possibly making comparisons

difficult.

• Only studies in the English language will be included, thereby introducing a possibility of

language bias.

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BACKGROUND

Rationale


approximately one-third of all elbow fractures.[1] The estimated annual incidence of radial head and

neck fractures are 2.8 per 10000.[2] The fractures often occur after indirect axial trauma following a

fall onto an outstretched arm. The mean age of a patient who fractures their radial head or neck are

between 44 to 48.[1–4]

The Mason classification is commonly used to describe radial head and neck fractures. The

classification is divided into four groups with Mason I being the most benign fracture type and Mason

IV more complicated fractures.[1, 5] Mason type I is a non-displaced fracture. Mason type II is a

fracture with more than 2 mm displacement, involving at least 30% of the radial head. Mason type III

fractures are significantly comminute, type IV is a fracture of the radial head or neck with associated

elbow dislocation, indicating greater trauma and greater soft tissue damage.[5]

The treatment of Mason type I fractures is conservative with aspiration of the hematoma in the joint,

a pressure bandage and sling for support, and active mobilization as early as possible.[6] There is

currently no consensus on the treatment of patients with Mason type II fractures. Both conservative

and surgical treatment is described with favourable outcome in the literature.[7–14] Comminute

fractures, Mason III-IV are treated in several ways. Both open reduction internal fixation (ORIF) and

arthroplasty are used as well as resection of the radial head.[11, 15, 16]

As described above, the treatment of radial head fractures is segmented. A few previous reviews

have investigated the functional outcome after radial head fractures. However the majority of these

were conducted over 5 years ago and are limited to just 1 or 2 of the Mason subclasses and are only

describing their results in descriptive ways.[9, 16–18] To our knowledge no standardized reviews

according to the PRISMA protocol have been published.[19]

The goal of this study is to summarize the outcome and treatment of radial head and neck fractures

with a systematic review. The results are important for both health care policy making and patient

care.

Objectives

This study will provide an overview of the recent published data on the subject of radial head and

neck fractures classified as Mason II to IV. A comparison of the functional outcome after different

interventions including ORIF, arthroplasty, radial head resection and conservative treatment will be

done. We aim to report the findings of this study in a way that makes it easy to use for clinical

decision making.

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METHOD AND ANALYSIS

The proposed systematic review and this protocol will conform to the Preferred Reporting Items for

Systematic Review and Meta-Analysis Protocol guidelines (PRISMA-P) and this protocol will be made

publicly available before we initiate the review process.[19] This study is also registered at the

International Prospective Register of Systematic Reviews (PROSPERO).

Eligibility criteria:

Population:

Studies with 20 or more adult patients (age 15 or older) with traumatic Mason II-IV radial head or

neck fractures are eligible for inclusion. Studies that primarily examine a specific age, gender or other

patient group will be excluded. There will be no upper limit on the follow-up time but reports with a

mean follow up time of less than one year are ineligible.

Intervention:

Studies with patients that can be sorted into one or several of the following categories:

Conservatively treated patients, patients treated with ORIF, arthroplasty or resection of the radial

head are eligible for inclusion. If several treatments and/or Mason groups are represented in a study

the patients will be subdivided and registered according to Mason classification and treatment

received.

Comparison:

Quantitative studies with a longitudinal design will be included, such as randomized controlled trials,

cohort studies, crossover studies, retrospective studies, and case-control studies. Data will be

collected regardless of the intervention received. Cross sectional studies and case-reports will be

excluded. To minimize bias due to high drop-out, reports with a higher drop-out rate than 30% will

not be taken into account.

Outcome:

The primary outcome will be the participants’ mean functional level measured with elbow and arm

scores. Secondary outcomes will be complication rates.

Search strategy

The search strategy will be constructed by and in discussion with a librarian with expertise in

healthcare databases and systematic reviews. We will search EMBASE, PubMed and the Cochrane

library and limit the search to studies published in the English language during the last 30 years. The

search strategy contains both Medical Subject Heading (MeSH) and non-MeSH terms. A less

extensive pre-search without review of the result will be done to calibrate the search strategy.

Depending on the time consumption of the review process an update search to include all the latest

articles might be conducted at the end of the review process. The search strategy for PubMed is

included in appendix 1.

Study records

Search results are going to be saved and managed in Endnote X7 (Thomson Reuters, Philadelphia, PA,

USA). M.H and A.T will screen titles and abstracts of the found articles. Full text will be obtained of all

articles that appear to meet, or if it’s unclear if the article meets, the predefined eligibility criteria. All

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exclusions and reasons for exclusion will be presented in a PRISMA flow chart together with the final

review.[19] All study data are going to be collected and managed using REDCap (Research Electronic

Data Capture) an electronic data capture tool hosted at Karolinska Institutet.[20] REDCap is a secure,

web-based application designed to support data capture for research studies, providing: 1) an

intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export

procedures; 3) automated export procedures for seamless data downloads to common statistical

packages; and 4) procedures for importing data from external sources. The data to be extracted is

presented in table 1. Both reviewers will separately examine and extract data from the included

studies, disagreement in the collected data will be resolved with discussion, if no consensus is

reached a third reviewer (O.S) will be consulted.

Table 1:

Data to be extracted:

Publication data Publication year, author Study data Design, size of population, type of intervention,

mean duration of follow-up, complication rate, drop-out rate, patient reported and/or functional outcome score(s).

Patient data Mean age, female percentage, type of fracture (classified according to Mason)

Outcomes and prioritization

Several scores are anticipated to be used in the included studies.[21] If a study reports the outcome

in more than one score, we will prioritize as follows: Mayo elbow performance score (MEPS), DASH,

quick-DASH and Broberg and Morreey index.[22, 23] The scores will be modified to make comparison

possible, for example all scales will be modified so that a lower score equals a worse outcome.

Complication rate include non-union, wound infection, radial nerve injuries and reoperations. The

complication rate will be measured as a percentage of patients included in the studies.

Risk of bias in individual studies

Randomized controlled trials will be independently assessed by A.T and M.H regarding bias with the

Cochrane Collaboration’s risk of bias tool. This tool includes assessment of random sequence

generation (selection bias), allocation concealment (selection bias), blinding of participants and

personnel (performance bias), blinding of outcome assessment (detection bias), incomplete outcome

data (attrition bias), selective reporting (reporting bias), baseline imbalance bias and other bias.[24]

To explore risk of bias in non-randomized studies the Newcastle-Ottawa scale will be used.

Newcastle-Ottawa scale has two different versions, one made to assess risk of bias in cohort studies

and one made to assess case-control studies, the two versions differ slightly. The scale contains three

categories: selection, comparability and exposure/outcome. These three categories are subdivided

into 7-8 items.[25]

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Data synthesis

The collected data will be presented using appropriate descriptive statistics. If the available data

permits, a meta-analysis will be conducted. The analysis will be performed using R version 3.2.3 (R

Foundation for Statistical Computing, Vienna, Austria), with the meta and metaphor packages.[26] A

random effects model will be applied as large heterogeneity regarding treatment conditions,

participant characteristics and methodological factors are expected between included studies. A

standardized mean difference will be calculated to make comparison possible between studies that

measure outcome with different rating scales. Non-parametric tests will then be conducted. If

important data is missing efforts will be made to contact the corresponding author.

Meta-Biases

We plan to assess the possibility of bias (publication bias, language bias and methodological biases)

by plotting the included studies in a funnel plot. Funnel plot asymmetry will be examined using

Eggers test of the intercept.[27]

Confidence in cumulative evidence

The outcomes will be assessed regarding quality of evidence using the Grading of Recommendation

Assessment, Development and Evaluation (GRADE).[28] Consideration will be given to each of the

GRADE criteria for assessing the quality of evidence. This approach grades the cumulative evidence

to one of four categories: high, moderate, low or very low evidence. The GRADE approach takes eight

items into account: study quality, inconsistency of result, indirectness of evidence, imprecision,

publication bias, large magnitude of effect, effect of plausible residual confounding.

DISCUSSION

We have not found any systematic review examining this area with a published protocol according to

PRISMA-P. Previously published systematic reviews suggest that there will be low evidence in the

published data with few RCTs.[17, 18, 29] Because of the lack of high quality papers we will include

both randomized and non-randomized studies. This approach enables a more comprehensive study

of the available evidence regarding functional outcome after radial head and neck fractures.

ACKNOWLEDGMENTS

We would like to express our sincere gratitude to librarian Alena Haarmann at the medical library of

Danderyd hospital for constructing the search strategy.

COMPETING INTERESTS

None

FUNDING

The study was funded by the Karolinska Institute, Department of clinical sciences at Danderyd

hospital.

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AUTHORS' CONTRIBUTIONS

M.H is the main author of the protocol and will write the final report. M.H and A.T will be responsible

for selection of articles and data extraction. O.S supervised M.H. and A.T., wrote the protocol and will

write the final report

REFERENCE

1 Mason ML. Some observations on fractures of the head of the radius with a review of one hundred cases. Br J Surg 1954;42:123–32. doi:10.1002/bjs.18004217203

2 Kaas L, van Riet RP, Vroemen JPAM, et al. The epidemiology of radial head fractures. J Shoulder Elbow Surg 2010;19:520–3. doi:10.1016/j.jse.2009.10.015

3 van Riet RP, Morrey BF, Driscoll SW, et al. Associated Injuries Complicating Radial Head Fractures: A Demographic Study. Clin Orthop 2005;441:351–5. doi:10.1097/01.blo.0000180606.30981.78

4 Duckworth AD, Clement ND, Jenkins PJ, et al. Socioeconomic deprivation predicts outcome following radial head and neck fractures. Injury 2012;43:1102–6. doi:10.1016/j.injury.2012.02.017

5 Johnston GW. A Follow-up of One Hundred Cases of Fracture of the Head of the Radius with a Review of the Literature. Ulster Med J 1962;31:51.

6 Mahmoud SSS, Moideen AN, Kotwal R, et al. Management of Mason type 1 radial head fractures: a regional survey and a review of literature. Eur J Orthop Surg Traumatol 2013;24:1133–7. doi:10.1007/s00590-013-1386-8

7 Esser RD, Davis S, Taavao T. Fractures of the Radial Head Treated by Internal Fixation: Late Results in 26 Cases. J Orthop Trauma 1995;9:318–23.

8 Geel CW, Palmer AK, Ruedi T, et al. Internal Fixation of Proximal Radial Head Fractures. J Orthop Trauma 1990;4:270–4.

9 Khalfayan EE, Culp RW, Alexander AH. Mason Type II Radial Head Fractures: Operative Versus Nonoperative Treatment. J Orthop Trauma 1992;6:283–9.

10 King GJW, Evans DC and, Kellam JF. Open Reduction and Internal Fixation of Radial Head Fractures. J Orthop Trauma 1991;5:21–8.

11 Pearce MS, Gallannaugh SC. Mason type II radial head fractures fixed with Herbert bone screws. J R Soc Med 1996;89:340P.

12 Ring D. Open reduction and internal fixation of fractures of the radial head. Hand Clin 2004;20:415–27. doi:10.1016/j.hcl.2004.06.001

13 Duckworth AD, Wickramasinghe NR, Clement ND, et al. Long-Term Outcomes of Isolated Stable Radial Head Fractures. J Bone Jt Surg Am 2014;96:1716–23. doi:10.2106/JBJS.M.01354

14 Åkesson T, Herbertsson P, Josefsson P-O, et al. Primary Nonoperative Treatment of Moderately Displaced Two-Part Fractures of the Radial Head. J Bone Jt Surg Am 2006;88:1909–14. doi:10.2106/JBJS.E.01052

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15 Antuña SA, Sánchez-Márquez JM, Barco R. Long-Term Results of Radial Head Resection Following Isolated Radial Head Fractures in Patients Younger Than Forty Years Old. J Bone Jt Surg 2010;92:558–66. doi:10.2106/JBJS.I.00332

16 Chen X, Wang S, Cao L, et al. Comparison between radial head replacement and open reduction and internal fixation in clinical treatment of unstable, multi-fragmented radial head fractures. Int Orthop 2010;35:1071–6. doi:10.1007/s00264-010-1107-4

17 Zwingmann J, Welzel M, Dovi-Akue D, et al. Clinical results after different operative treatment methods of radial head and neck fractures: A systematic review and meta-analysis of clinical outcome. Injury 2013;44:1540–50. doi:10.1016/j.injury.2013.04.003

18 Humadi A, Unnim R, Miller G, et al. Surgical management of Mason type III radial head fractures. Indian J Orthop 2013;47:323. doi:10.4103/0019-5413.114907

19 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:10.1136/bmj.g7647

20 Paul A Harris RT. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. J Biomed Inform 2008;42:377–81. doi:10.1016/j.jbi.2008.08.010

21 Longo UG, Franceschi F, Loppini M, et al. Rating systems for evaluation of the elbow. Br Med Bull 2008;87:131–61. doi:10.1093/bmb/ldn023

22 Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med 1996;29:602–8. doi:10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L

23 Beaton DE, Wright JG, Katz JN, et al. Development of the QuickDASH: Comparison of Three Item-Reduction Approaches. J Bone Jt Surg Am 2005;87:1038–46. doi:10.2106/JBJS.D.02060

24 Higgins J, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0 [updated March 2011]. The Cochrane Collaboration 2011. Available from http://handbook.cochrane.org

25 Wells G, Shea B, O’Connell D, et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomized studies in meta-analysis. http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp (accessed 22 Apr2016).

26 Viechtbauer W, others. Conducting meta-analyses in R with the metafor package. J Stat Softw 2010;36:1–48.

27 Egger M, Davey Smith G, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629–34.

28 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:10.1136/bmj.39489.470347.AD

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29 Li N, Chen S. Open reduction and internal-fixation versus radial head replacement in treatment of Mason type III radial head fractures. Eur J Orthop Surg Traumatol 2013;24:851–5. doi:10.1007/s00590-013-1367-y

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SEARCH STRATEGY

1. “Radius”[Mesh]

2. “Elbow”[Mesh]

3. “Elbow Joint”[Mesh]

4. radius[tiab]

5. elbow[tiab]

6. elbows[tiab]

7. elbow joint*[tiab]

8. radial head*[tiab]

9. radial neck*[tiab]

10. 1 OR 2 OR 3 OR 4 OR 5 OR 6 OR 7 OR 8 OR 9

11. “Radius Fractures”[Mesh]

12. “Fractures, Bone”[Mesh]

13. “Fracture Healing”[Mesh]

14. “Fractures, Malunited”[Mesh]

15. “Intra-Articular Fractures”[Mesh]

16. “Fractures, Open”[Mesh]

17. “Fractures, Closed”[Mesh]

18. “Fractures, Comminuted”[Mesh]

19. “Fractures, Compression”[Mesh]

20. “Fractures, Multiple”[Mesh]

21. “Fractures, Ununited”[Mesh]

22. broken bone*[tiab]

23. fracture[tiab]

24. fractures[tiab]

25. Mason II[tiab]

26. Mason III[tiab]

27. Mason IV[tiab]

28. Mason type II[tiab]

29. Mason type III[tiab]

30. Mason type IV[tiab]

31. terrible triad*[tiab]

32. radial head dislocation*[tiab]

33. 11 OR 12 OR 13 OR 14 OR 15 OR 16 OR 17 OR 18 OR 19 OR 20 OR 21 OR 22 OR 23 OR 24 OR

25 OR 26 OR 27 OR 28 OR 29 OR 30 OR 31 OR 32

34. 10 AND 33

35. “Arthroplasty”[Mesh]

36. “Arthroplasty, Replacement, Elbow”[Mesh]

37. “Arthroplasty, Replacement”[Mesh]

38. “Elbow Prosthesis”[Mesh]

39. “Prosthesis Implantation”[Mesh]

40. “Fracture Fixation”[Mesh]

41. “Fracture Fixation, Internal”[Mesh]

42. “Fracture Fixation, Intramedullary”[Mesh]

43. “Surgical Procedures, Operative”[Mesh]

44. arthroplasty[tiab]

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45. arthroplasties[tiab]

46. total elbow replacement*[tiab]

47. prosthesis[tiab]

48. prostheses[tiab]

49. prothesis[tiab]

50. protheses[tiab]

51. fracture fixation*[tiab]

52. skeletal fixation*[tiab]

53. fracture osteosynthes*[tiab]

54. operative surgical procedure*[tiab]

55. operative procedure*[tiab]

56. ORIF[tiab]

57. open reduction*[tiab]

58. closed reduction*[tiab]

59. percutaneous reduction*[tiab]

60. conservative treatment*[tiab]

61. non-conservative treatment*[tiab]

62. nonconservative treatment*[tiab]

63. surgical treatment*[tiab]

64. non-surgical treatment*[tiab]

65. nonsurgical treatment*[tiab]

66. non-operative management*[tiab]

67. nonoperative management*[tiab]

68. non-operatively[tiab]

69. nonoperatively[tiab]

70. operative treatment*[tiab]

71. non-operative treatment*[tiab]

72. nonoperative treatment*[tiab]

73. surgical intervention*[tiab]

74. surgical management*[tiab]

75. implant[tiab]

76. implants[tiab]

77. radial head replacement*[tiab]

78. radial head excision*[tiab]

79. radial head reconstruction*[tiab]

80. radial head resection*[tiab]

81. arthroscopic excision[tiab]

82. casting[tiab]

83. intramedullary pin*[tiab]

84. centromedullary pinning[tiab]

85. percutaneous pin*[tiab]

86. intramedullary nail*[tiab]

87. intramedullary fixation*[tiab]

88. intramedullary rod*[tiab]

89. intramedullary reduction[tiab]

90. plate[tiab]

91. plates[tiab]

92. screw[tiab]

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93. screws[tiab]

94. wire[tiab]

95. wires[tiab]

96. nail[tiab]

97. nails[tiab]

98. pin fixation*[tiab]

99. bioabsorbable pin*[tiab]

100. bioabsorbable fixation[tiab]

101. absorbable rod*[tiab]

102. absorbable fixation[tiab]

103. bone paste[tiab]

104. bone cement[tiab]

105. bone graft[tiab]

106. bone grafting[tiab]

107. treatment recommendation*[tiab]


49 OR 50 OR 51 OR 52 OR 53 OR 54 OR 55 OR 56 OR 57 OR 58 OR 59 OR 60 OR 61 OR 62 OR



91 OR 92 OR 93 OR 94 OR 95 OR 96 OR 97 OR 98 OR 99 OR 100 OR 101 OR 102 OR 103 OR

104 OR 105 OR 106 OR 107

109. “Treatment Outcome”[Mesh]

110. “Recovery of Function”[Mesh]

111. “Range of Motion, Articular”[Mesh]

112. “Follow-Up Studies”[Mesh]

113. “Postoperative Complications”[Mesh]

114. treatment outcome*[tiab]

115. clinical effectiveness*[tiab]

116. patient-relevant outcome*[tiab]

117. clinical efficac*[tiab]

118. treatment effectiveness*[tiab]

119. treatment efficac*[tiab]

120. rehabilitation outcome*[tiab]

121. recovery of function*[tiab]

122. function recovery[tiab]

123. function recoveries[tiab]

124. range of motion*[tiab]

125. joint flexibilit*[tiab]

126. follow-up stud*[tiab]

127. followup stud*[tiab]

128. postoperative complication*[tiab]

129. long-term outcome*[tiab]

130. longterm outcome*[tiab]

131. clinical outcome*[tiab]

132. functional outcome*[tiab]

133. 109 OR 110 OR 111 OR 112 OR 113 OR 114 OR 115 OR 116 OR 117 OR 118 OR 119 OR 120

OR 121 OR 122 OR 123 OR 124 OR 125 OR 126 OR 127 OR 128 OR 129 OR 130 OR 131 OR 132

134. 108 OR 133

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135. 34 AND 134

136. 135 AND ("1986/01/01"[Date - Publication] : "3000"[Date - Publication])

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PRISMA-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) 2015 checklist: recommended items to

address in a systematic review protocol*

Section and topic Item No Checklist item

ADMINISTRATIVE INFORMATION

Title:

Identification 1a Identify the report as a protocol of a systematic review

Update 1b If the protocol is for an update of a previous systematic review, identify as such

Registration 2 If registered, provide the name of the registry (such as PROSPERO) and registration number

Authors:

Contact 3a Provide name, institutional affiliation, e-mail address of all protocol authors; provide physical mailing address of

corresponding author

Contributions 3b Describe contributions of protocol authors and identify the guarantor of the review

Amendments 4 If the protocol represents an amendment of a previously completed or published protocol, identify as such and list changes;

otherwise, state plan for documenting important protocol amendments

Support:

Sources 5a Indicate sources of financial or other support for the review

Sponsor 5b Provide name for the review funder and/or sponsor

Role of sponsor or funder 5c Describe roles of funder(s), sponsor(s), and/or institution(s), if any, in developing the protocol

INTRODUCTION

Rationale 6 Describe the rationale for the review in the context of what is already known

Objectives 7 Provide an explicit statement of the question(s) the review will address with reference to participants, interventions,

comparators, and outcomes (PICO)

METHODS

Eligibility criteria 8 Specify the study characteristics (such as PICO, study design, setting, time frame) and report characteristics (such as years

considered, language, publication status) to be used as criteria for eligibility for the review

Information sources 9 Describe all intended information sources (such as electronic databases, contact with study authors, trial registers or other

grey literature sources) with planned dates of coverage

Search strategy 10 Present draft of search strategy to be used for at least one electronic database, including planned limits, such that it could be

repeated

Study records:

Data management 11a Describe the mechanism(s) that will be used to manage records and data throughout the review

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Selection process 11b State the process that will be used for selecting studies (such as two independent reviewers) through each phase of the

review (that is, screening, eligibility and inclusion in meta-analysis)

Data collection process 11c Describe planned method of extracting data from reports (such as piloting forms, done independently, in duplicate), any

processes for obtaining and confirming data from investigators

Data items 12 List and define all variables for which data will be sought (such as PICO items, funding sources), any pre-planned data

assumptions and simplifications

Outcomes and prioritization 13 List and define all outcomes for which data will be sought, including prioritization of main and additional outcomes, with

rationale

Risk of bias in individual studies 14 Describe anticipated methods for assessing risk of bias of individual studies, including whether this will be done at the

outcome or study level, or both; state how this information will be used in data synthesis

Data synthesis 15a Describe criteria under which study data will be quantitatively synthesised

15b If data are appropriate for quantitative synthesis, describe planned summary measures, methods of handling data and

methods of combining data from studies, including any planned exploration of consistency (such as I2, Kendall’s τ)

15c Describe any proposed additional analyses (such as sensitivity or subgroup analyses, meta-regression)

15d If quantitative synthesis is not appropriate, describe the type of summary planned

Meta-bias(es) 16 Specify any planned assessment of meta-bias(es) (such as publication bias across studies, selective reporting within studies)

Confidence in cumulative evidence 17 Describe how the strength of the body of evidence will be assessed (such as GRADE)

* It is strongly recommended that this checklist be read in conjunction with the PRISMA-P Explanation and Elaboration (cite when available) for important

clarification on the items. Amendments to a review protocol should be tracked and dated. The copyright for PRISMA-P (including checklist) is held by the

PRISMA-P Group and is distributed under a Creative Commons Attribution Licence 4.0.

From: Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart L, PRISMA-P Group. Preferred reporting items for systematic review and

meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015 Jan 2;349(jan02 1):g7647.

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Functional outcome after Mason II-III radial head and neck



Journal: BMJ Open

Manuscript ID bmjopen-2016-013022.R1


Date Submitted by the Author: 06-Sep-2016

Complete List of Authors: Hagelberg, Mårten; Karolinska Institutet Department of Clinical Sciences Danderyd Hospital, Thune, Alexandra; Karolinska Institutet, Department of clinical sciences at Danderyd hospital Krupic, Ferid; Goteborgs universitet Sahlgrenska Akademin Salomonsson, Björn; Karolinska Institutet Department of Clinical Sciences Danderyd Hospital Sköldenberg, Olof; Karolinska Institutet, Department of clinical sciences at Danderyd hospital


Surgery


Keywords: Radial head and neck fractures, Elbow & shoulder < ORTHOPAEDIC & TRAUMA SURGERY, Treatment outcome, Systematic review protocol


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FunctionaloutcomeafterMasonII-III




Mårten Hagelberg1, Alexandra Thune1, Ferid Krupic2, Björn Salomonsson1, Olof Sköldenberg1

1 Karolinska Institute, Department of Clinical Sciences at Danderyd Hospital, Stockholm, Sweden.

2University of Gothenburg Institute of Clinical Sciences, Sahlgrenska Akademy, University of

Gothenburg,Mölndal, Sweden.


Sciences, Unit of Orthopaedics, Karolinska Institute at Danderyd Hospital, S-182 88 Danderyd,

Sweden. Tel +46-8-6555000. Fax +46-8-7551476.




Word count: 2170

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ABSTRACT

Introduction



either conservative or surgical. There is no absolute consensus regarding optimal treatment for

different fracture types. The aim of this protocol is to present the method that will be used to collect,

describe and analyse the current evidence regarding the treatment of Mason II-III radial head and

neck fractures.

Method and analysis

We will conduct a systematic review in accordance with the Preferred Reporting Items for Systematic

Review and Meta-Analysis Protocol guidelines (PRISMA-P) statement. We will search a number of

databases with a predefined search strategy to collect both randomized and non-randomized

studies. The articles will be summarized with descriptive statistics. If applicable a meta-analysis will

be conducted.

Ethics and dissemination

Ethical approval is not required since this is a protocol for a systematic review and no primary data

will be collected. The authors will publish findings from this review in a peer-reviewed scientific

journal.

Trial registration number

PROSPERO registration number: 2016:CRD42016037627

STRENGHTS AND LIMITATIONS

• A review on this subject has never to our knowledge been performed before according to

PRISMA standard.

• Very common injury with clinical significance for patients.

• No clear consensus regarding optimal treatment.

• There are few randomized controlled trials on the subject

• Heterogenic outcomes and methods across the literature possibly making comparisons

difficult.

• Only studies in the English language will be included, thereby introducing a possibility of

language bias.

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BACKGROUND

Rationale


approximately one-third of all elbow fractures. The estimated annual incidence of radial head and

neck fractures are 2.8 per 10000. The fractures often occur after indirect axial trauma following a fall

onto an outstretched arm. The mean age of a patient who fractures their radial head or neck are

between 44 to 48 and the male to female ratio is 2/3.[1–4]

The Mason classification is used to describe radial head and neck fractures. The classification is

commonly divided into four groups and has been modified several times. According to the iteration

by Broberg and Morrey, Mason I is a non-displaced fracture, Mason II is a fracture with more than 2

mm displacement, involving at least 30% of the radial head, Mason III fractures are significantly

comminute and Mason IV is a fracture of the radial head or neck with associated elbow dislocation.

Mason IV usually indicates greater trauma and greater soft tissue damage but is a very heterogenic

group. It is a heterogenic group since both a minimally displaced and severely comminute fracture

could be classified as Mason IV as long as the patient also has an elbow dislocation. There are no

significant differences in age or gender disposition between the different Mason groups.[3–6]

The treatment of Mason I fractures is conservative with aspiration of the hematoma in the joint, a

pressure bandage and sling for support, and active mobilization as early as possible. There is

currently no consensus on the treatment of patients with Mason type II fractures. Both conservative

and surgical treatment is described with favourable outcome in the literature. Mason III-IV are

treated in several ways, both open reduction internal fixation (ORIF) and arthroplasty are used as

well as resection of the radial head.[7–15]

As described above, the treatment of radial head fractures is segmented. A few previous reviews

have investigated the functional outcome after radial head fractures. However the majority of these

were conducted over 5 years ago and are only describing their results in descriptive ways.

To our knowledge no standardized reviews according to the PRISMA protocol have been

published.[16]

The goal of this study is to summarize the outcome and treatment of radial head and neck fractures

with a systematic review. The results are important for both health care policy making and patient

care.

Objectives

This study will provide an overview of the recent published data on the subject of radial head and

neck fractures classified as Mason II to III. A comparison of the functional outcome after different

interventions including ORIF, arthroplasty, radial head resection and conservative treatment will be

done. We aim to report the findings of this study in a way that makes it easy to use for clinical

decision making.

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METHOD AND ANALYSIS

The proposed systematic review and this protocol will conform to the Preferred Reporting Items for

Systematic Review and Meta-Analysis Protocol guidelines (PRISMA-P) and this protocol will be made

publicly available before we initiate the review process. This study is also registered at the

International Prospective Register of Systematic Reviews (PROSPERO).[16]

Eligibility criteria:

Population:

Studies with 20 or more adult patients (age 15 or older) with traumatic Mason II-III radial head or

neck fractures are eligible for inclusion. Studies that primarily examine a specific age, gender or other

patient group will be excluded. There will be no upper limit on the follow-up time but reports with a

mean follow up time of less than one year are ineligible.

Intervention:

Studies with patients that can be sorted into one or several of the following categories:

Conservatively treated patients, patients treated with ORIF, arthroplasty or resection of the radial

head are eligible for inclusion. If several treatments and/or Mason groups are represented in a study

the patients will be subdivided and registered according to Mason classification and treatment

received. Patients described to have associated injuries such as elbow dislocation or Essex-Lopresti

injury will be excluded.

Comparison:

Quantitative studies with a longitudinal design will be included, such as randomized controlled trials,

cohort studies, crossover studies, retrospective studies, and case-control studies. Data will be

collected regardless of the intervention received. Cross sectional studies and case-reports will be

excluded. To minimize bias due to high drop-out, reports with a higher drop-out rate than 30% will

not be taken into account. Only studies that use a Mason classification will be included. We will

adapt the studies to the Broberg-Morrey iteration of the Mason classification.

Outcome:

The primary outcome will be the participants’ mean functional level measured with elbow and arm

scores. Secondary outcomes will be complication rates, pain and range of motion.

Search strategy

The search strategy will be constructed by and in discussion with a librarian with expertise in

healthcare databases and systematic reviews. We will search EMBASE, PubMed and the Cochrane

library and limit the search to studies published in the English language during the last 30 years. The

search strategy contains both Medical Subject Heading (MeSH) and non-MeSH terms. A less

extensive pre-search without review of the result will be done to calibrate the search strategy.

Depending on the time consumption of the review process an update search to include all the latest

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articles might be conducted at the end of the review process. The search strategy for PubMed is

included in appendix 1.

Study records

Search results are going to be saved and managed in Endnote X7 (Thomson Reuters, Philadelphia, PA,

USA). M.H and A.T will screen titles and abstracts of the found articles. Full text will be obtained of all

articles that appear to meet, or if it’s unclear if the article meets, the predefined eligibility criteria. All

exclusions and reasons for exclusion will be presented in a PRISMA flow chart together with the final

review.[16] All study data are going to be collected and managed using REDCap (Research Electronic

Data Capture) an electronic data capture tool hosted at Karolinska Institute.[17] REDCap is a secure,

web-based application designed to support data capture for research studies, providing: 1) an

intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export

procedures; 3) automated export procedures for seamless data downloads to common statistical

packages; and 4) procedures for importing data from external sources. The data to be extracted is

presented in table 1. Both reviewers will separately examine and extract data from the included

studies, disagreement in the collected data will be resolved with discussion, if no consensus is

reached a third reviewer (O.S) will be consulted.

Table 1:

Data to be extracted:

Publication data Publication year, author Study data Design, size of population, type of intervention,

mean duration of follow-up, complication rate (including pain and range of motion), drop-out rate, patient reported and/or functional outcome score(s), implant type.

Patient data Mean age, female percentage, type of fracture (classified according to Mason)

Outcomes and prioritization

Several scores are anticipated to be used in the included studies.[18] If a study reports the outcome

in more than one score, we will prioritize as follows:, Disabilities of the Arm, Shoulder and Hand

(DASH), quick-DASH, Mayo elbow performance score (MEPS) and Broberg and Morrey index.[19,20]

The scores will be modified to make comparison possible, for example all scales will be modified so

that a lower score equals a worse outcome. Complication rate include non-union, wound infection,

radial nerve injuries and reoperations. The complication rate will be measured as a percentage of

patients included in the studies. We will also, if available, extract rated pain and range of motion.

Risk of bias in individual studies

Randomized controlled trials will be independently assessed by A.T and M.H regarding bias with the

Cochrane Collaboration’s risk of bias tool. This tool includes assessment of random sequence

generation (selection bias), allocation concealment (selection bias), blinding of participants and

personnel (performance bias), blinding of outcome assessment (detection bias), incomplete outcome

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data (attrition bias), selective reporting (reporting bias), baseline imbalance bias and other bias.[21]

To explore risk of bias in non-randomized studies the Newcastle-Ottawa scale will be used.

Newcastle-Ottawa scale has two different versions, one made to assess risk of bias in cohort studies

and one made to assess case-control studies, the two versions differ slightly. The scale contains three

categories: selection, comparability and exposure/outcome. These three categories are subdivided

into 7-8 items.[22]

Data synthesis

The collected data will be presented using appropriate descriptive statistics. If the available data

permits, a meta-analysis will be conducted. We will subdivide and present the results according to

Mason group and intervention received. If a manageable amount of studies are found we will also

present the studies separate with all the extracted data. If this is not possible the data will be added

as an appendix. The analysis will be performed using R version 3.2.3 (R Foundation for Statistical

Computing, Vienna, Austria), with the meta and metaphor packages.[23] A random effects model will

be applied as large heterogeneity regarding treatment conditions, participant characteristics and

methodological factors are expected between included studies. A standardized mean difference will

be calculated to make comparison possible between studies that measure outcome with different

rating scales. Non-parametric tests will then be conducted. If important data is missing efforts will be

made to contact the corresponding author.

Meta-Biases

We plan to assess the possibility of bias (publication bias, language bias and methodological biases)

by plotting the included studies in a funnel plot. Funnel plot asymmetry will be examined using

Eggers test of the intercept.[24]

Confidence in cumulative evidence

The outcomes will be assessed regarding quality of evidence using the Grading of Recommendation

Assessment, Development and Evaluation (GRADE).[25] Consideration will be given to each of the

GRADE criteria for assessing the quality of evidence. This approach grades the cumulative evidence

to one of four categories: high, moderate, low or very low evidence. The GRADE approach takes eight

items into account: study quality, inconsistency of result, indirectness of evidence, imprecision,

publication bias, large magnitude of effect, effect of plausible residual confounding.

DISCUSSION

We have not found any systematic review examining this area with a published protocol according to

PRISMA-P. Previously published systematic reviews suggest that there will be low evidence in the

published data with few RCTs.[26–28] Because of the lack of high quality papers we will include both

randomized and non-randomized studies. This approach enables a more comprehensive study of the

available evidence regarding functional outcome after radial head and neck fractures.

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As mentioned in the method section the Mason classification will be used in this review. This is a

classification system with limitations since it has been revised several times. Some studies use the

original three category classification while others use Broberg-Morreys or Hotchkiss four category

iteration. The Hotchkiss and the Broberg-Morrey are quite similar and we will assume that a patient

placed in a Hotchkiss group would be placed into the corresponding Broberg-Morrey group. This

approach will in a few cases place the patients into wrong group introducing a limitation we will have

to take into account when interpreting the results. A similar approach has previously been used by L.

Kaas et al.[29]

The intra and inter observability when diagnosing radial head and neck fractures is not as good as

one could wish for. This is a problem that several other fracture classification systems have as well

such as the Neer classification of proximal humeral fractures. However, the Mason classification is

the most commonly used in both clinical and research settings and even though it has several

shortcomings it is currently the only practical way of studying radial head and neck fractures.[30,31]

When studying radial head and neck fractures, associated injuries such as elbow dislocation and

Essex-Lopresti injuries are of great concern. We will exclude patients that are described to have

associated injuries. Since a fracture of the radial head or neck with an elbow dislocation should be

classified as a Mason IV these patients will if correctly diagnosed not alter the results of this review.

Essex-Lopresti is a complicating factor that is sometimes overlooked but it is quite uncommon and

should be of minor impact of this review, Grassman et al. found 12 patients with Essex-Lopresti injury

out of 295 patients with radial head fractures.[32]

Stiffness, range of motion, pain and mechanical blockage are important measures of complication

but not always reported in an adequate way. To be able to get information covering these factors we

will as mentioned use DASH as our main outcome. DASH is a 30 item questionnaire that includes 3

items covering pain and several questions covering stiffness and range of motion in an indirect

manner.[19,29]

This is not the first review of this area but we believe that there is a need for an updated systematic

review of this topic. A Cochrane study published 2013, only including RCT’s, found three studies.

With our review we will try to summarize more of the published studies available by also including

other cohort studies. This will of course lower the possibility to draw firm conclusions but it will give

a broader view of the available evidence. A study by Kaas L et al. was more thorough but is now five

years old. We anticipate that by including more recent publications we will be able to present the

best available evidence regarding the best treatment of Mason II-III radial head and neck

fractures.[29,33]

ACKNOWLEDGMENTS

We would like to express our sincere gratitude to librarian Alena Haarmann at the medical library of

Danderyd hospital for constructing the search strategy.

COMPETING INTERESTS

None

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FUNDING

The study was funded by the Karolinska Institute, Department of clinical sciences at Danderyd

hospital.

AUTHORS' CONTRIBUTIONS

M.H is the main author of the protocol and will write the final report. M.H and A.T will be responsible

for selection of articles and data extraction. O.S supervised M.H. and A.T., wrote the protocol and will

write the final report. B.S and F.K helped with writing the revised protocol and will write the final

report.

REFERENCE

1 van Riet RP, Morrey BF, O???Driscoll SW, et al. Associated Injuries Complicating Radial Head Fractures: A Demographic Study. Clin Orthop 2005;441:351–5. doi:10.1097/01.blo.0000180606.30981.78

2 Duckworth AD, Clement ND, Jenkins PJ, et al. Socioeconomic deprivation predicts outcome following radial head and neck fractures. Injury 2012;43:1102–6. doi:10.1016/j.injury.2012.02.017

3 Kaas L, van Riet RP, Vroemen JPAM, et al. The epidemiology of radial head fractures. J Shoulder Elbow Surg 2010;19:520–3. doi:10.1016/j.jse.2009.10.015

4 Mason ML. Some observations on fractures of the head of the radius with a review of one hundred cases. Br J Surg 1954;42:123–32. doi:10.1002/bjs.18004217203

5 Johnston GW. A Follow-up of One Hundred Cases of Fracture of the Head of the Radius with a Review of the Literature. Ulster Med J 1962;31:51.

6 Broberg MA, Morrey BF. Results of treatment of fracture-dislocations of the elbow. Clin Orthop 1987;:109–19.

7 Esser RD, Davis S, Taavao T. Fractures of the Radial Head Treated by Internal Fixation: Late Results in 26 Cases. J Orthop Trauma 1995;9:318–23.

8 Geel CW, Palmer AK, Ruedi T, et al. Internal Fixation of Proximal Radial Head Fractures. J Orthop Trauma 1990;4:270–4.

9 Khalfayan EE, Culp RW, Alexander AH. Mason Type II Radial Head Fractures: Operative Versus Nonoperative Treatment. J Orthop Trauma 1992;6:283–9.

10 King GJW, Evans DC and, Kellam JF. Open Reduction and Internal Fixation of Radial Head Fractures. J Orthop Trauma 1991;5:21–8.

11 Pearce MS, Gallannaugh SC. Mason type II radial head fractures fixed with Herbert bone screws. J R Soc Med 1996;89:340P.

12 Ring D. Open reduction and internal fixation of fractures of the radial head. Hand Clin 2004;20:415–27. doi:10.1016/j.hcl.2004.06.001

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9

13 Duckworth AD, Wickramasinghe NR, Clement ND, et al. Long-Term Outcomes of Isolated Stable Radial Head Fractures. J Bone Jt Surg Am 2014;96:1716–23. doi:10.2106/JBJS.M.01354

14 Åkesson T, Herbertsson P, Josefsson P-O, et al. Primary Nonoperative Treatment of Moderately Displaced Two-Part Fractures of the Radial Head. J Bone Jt Surg Am 2006;88:1909–14. doi:10.2106/JBJS.E.01052

15 Antuña SA, Sánchez-Márquez JM, Barco R. Long-Term Results of Radial Head Resection Following Isolated Radial Head Fractures in Patients Younger Than Forty Years Old. J Bone Jt Surg 2010;92:558–66. doi:10.2106/JBJS.I.00332

16 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:10.1136/bmj.g7647

17 Paul A Harris RT. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. J Biomed Inform 2008;42:377–81. doi:10.1016/j.jbi.2008.08.010

18 Longo UG, Franceschi F, Loppini M, et al. Rating systems for evaluation of the elbow. Br Med Bull 2008;87:131–61. doi:10.1093/bmb/ldn023

19 Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med 1996;29:602–8. doi:10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L

20 Beaton DE, Wright JG, Katz JN, et al. Development of the QuickDASH: Comparison of Three Item-Reduction Approaches. J Bone Jt Surg Am 2005;87:1038–46. doi:10.2106/JBJS.D.02060

21 Higgins J, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0 [updated March 2011]. The Cochrane Collaboration 2011. Available from http://handbook.cochrane.org

22 Wells G, Shea B, O’Connell D, et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomized studies in meta-analysis. http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp (accessed 22 Apr2016).

23 Viechtbauer W, others. Conducting meta-analyses in R with the metafor package. J Stat Softw 2010;36:1–48.

24 Egger M, Davey Smith G, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629–34.

25 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:10.1136/bmj.39489.470347.AD

26 Humadi A, Unnim R, Miller G, et al. Surgical management of Mason type III radial head fractures. Indian J Orthop 2013;47:323. doi:10.4103/0019-5413.114907

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27 Li N, Chen S. Open reduction and internal-fixation versus radial head replacement in treatment of Mason type III radial head fractures. Eur J Orthop Surg Traumatol 2013;24:851–5. doi:10.1007/s00590-013-1367-y

28 Zwingmann J, Welzel M, Dovi-Akue D, et al. Clinical results after different operative treatment methods of radial head and neck fractures: A systematic review and meta-analysis of clinical outcome. Injury 2013;44:1540–50. doi:10.1016/j.injury.2013.04.003

29 Kaas L, Struijs PAA, Ring D, et al. Treatment of Mason Type II Radial Head Fractures Without Associated Fractures or Elbow Dislocation: A Systematic Review. J Hand Surg 2012;37:1416–21. doi:10.1016/j.jhsa.2012.03.042

30 Carofino BC, Leopold SS. Classifications in Brief: The Neer Classification for Proximal Humerus Fractures. Clin Orthop Relat Res 2013;471:39–43. doi:10.1007/s11999-012-2454-9

31 Iannuzzi NP, Leopold SS. In Brief: The Mason Classification of Radial Head Fractures. Clin Orthop Relat Res 2012;470:1799–802. doi:10.1007/s11999-012-2319-2

32 Grassmann JP, Hakimi M, Gehrmann SV, et al. The treatment of the acute Essex-Lopresti injury. Bone Jt J 2014;96–B:1385–91. doi:10.1302/0301-620X.96B10.33334

33 Surgical interventions for treating radial head fractures in adults - Gao - 2013 - The Cochrane Library - Wiley Online Library. http://onlinelibrary.wiley.com.proxy.kib.ki.se/doi/10.1002/14651858.CD008987.pub2/abstract;jsessionid=F70A401AB4C2E66E59E4121977577427.f04t01 (accessed 22 Aug2016).

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SEARCH STRATEGY

1. “Radius”[Mesh]

2. “Elbow”[Mesh]

3. “Elbow Joint”[Mesh]

4. radius[tiab]

5. elbow[tiab]

6. elbows[tiab]

7. elbow joint*[tiab]

8. radial head*[tiab]

9. radial neck*[tiab]

10. 1 OR 2 OR 3 OR 4 OR 5 OR 6 OR 7 OR 8 OR 9

11. “Radius Fractures”[Mesh]

12. “Fractures, Bone”[Mesh]

13. “Fracture Healing”[Mesh]

14. “Fractures, Malunited”[Mesh]

15. “Intra-Articular Fractures”[Mesh]

16. “Fractures, Open”[Mesh]

17. “Fractures, Closed”[Mesh]

18. “Fractures, Comminuted”[Mesh]

19. “Fractures, Compression”[Mesh]

20. “Fractures, Multiple”[Mesh]

21. “Fractures, Ununited”[Mesh]

22. broken bone*[tiab]

23. fracture[tiab]

24. fractures[tiab]

25. Mason II[tiab]

26. Mason III[tiab]

27. Mason IV[tiab]

28. Mason type II[tiab]

29. Mason type III[tiab]

30. Mason type IV[tiab]

31. terrible triad*[tiab]

32. radial head dislocation*[tiab]


25 OR 26 OR 27 OR 28 OR 29 OR 30 OR 31 OR 32

34. 10 AND 33

35. “Arthroplasty”[Mesh]

36. “Arthroplasty, Replacement, Elbow”[Mesh]

37. “Arthroplasty, Replacement”[Mesh]

38. “Elbow Prosthesis”[Mesh]

39. “Prosthesis Implantation”[Mesh]

40. “Fracture Fixation”[Mesh]

41. “Fracture Fixation, Internal”[Mesh]

42. “Fracture Fixation, Intramedullary”[Mesh]

43. “Surgical Procedures, Operative”[Mesh]

44. arthroplasty[tiab]

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45. arthroplasties[tiab]

46. total elbow replacement*[tiab]

47. prosthesis[tiab]

48. prostheses[tiab]

49. prothesis[tiab]

50. protheses[tiab]

51. fracture fixation*[tiab]

52. skeletal fixation*[tiab]

53. fracture osteosynthes*[tiab]

54. operative surgical procedure*[tiab]

55. operative procedure*[tiab]

56. ORIF[tiab]

57. open reduction*[tiab]

58. closed reduction*[tiab]

59. percutaneous reduction*[tiab]

60. conservative treatment*[tiab]

61. non-conservative treatment*[tiab]

62. nonconservative treatment*[tiab]

63. surgical treatment*[tiab]

64. non-surgical treatment*[tiab]

65. nonsurgical treatment*[tiab]

66. non-operative management*[tiab]

67. nonoperative management*[tiab]

68. non-operatively[tiab]

69. nonoperatively[tiab]

70. operative treatment*[tiab]

71. non-operative treatment*[tiab]

72. nonoperative treatment*[tiab]

73. surgical intervention*[tiab]

74. surgical management*[tiab]

75. implant[tiab]

76. implants[tiab]

77. radial head replacement*[tiab]

78. radial head excision*[tiab]

79. radial head reconstruction*[tiab]

80. radial head resection*[tiab]

81. arthroscopic excision[tiab]

82. casting[tiab]

83. intramedullary pin*[tiab]

84. centromedullary pinning[tiab]

85. percutaneous pin*[tiab]

86. intramedullary nail*[tiab]

87. intramedullary fixation*[tiab]

88. intramedullary rod*[tiab]

89. intramedullary reduction[tiab]

90. plate[tiab]

91. plates[tiab]

92. screw[tiab]

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93. screws[tiab]

94. wire[tiab]

95. wires[tiab]

96. nail[tiab]

97. nails[tiab]

98. pin fixation*[tiab]

99. bioabsorbable pin*[tiab]

100. bioabsorbable fixation[tiab]

101. absorbable rod*[tiab]

102. absorbable fixation[tiab]

103. bone paste[tiab]

104. bone cement[tiab]

105. bone graft[tiab]

106. bone grafting[tiab]

107. treatment recommendation*[tiab]





91 OR 92 OR 93 OR 94 OR 95 OR 96 OR 97 OR 98 OR 99 OR 100 OR 101 OR 102 OR 103 OR

104 OR 105 OR 106 OR 107

109. “Treatment Outcome”[Mesh]

110. “Recovery of Function”[Mesh]

111. “Range of Motion, Articular”[Mesh]

112. “Follow-Up Studies”[Mesh]

113. “Postoperative Complications”[Mesh]

114. treatment outcome*[tiab]

115. clinical effectiveness*[tiab]

116. patient-relevant outcome*[tiab]

117. clinical efficac*[tiab]

118. treatment effectiveness*[tiab]

119. treatment efficac*[tiab]

120. rehabilitation outcome*[tiab]

121. recovery of function*[tiab]

122. function recovery[tiab]

123. function recoveries[tiab]

124. range of motion*[tiab]

125. joint flexibilit*[tiab]

126. follow-up stud*[tiab]

127. followup stud*[tiab]

128. postoperative complication*[tiab]

129. long-term outcome*[tiab]

130. longterm outcome*[tiab]

131. clinical outcome*[tiab]

132. functional outcome*[tiab]

133. 109 OR 110 OR 111 OR 112 OR 113 OR 114 OR 115 OR 116 OR 117 OR 118 OR 119 OR 120

OR 121 OR 122 OR 123 OR 124 OR 125 OR 126 OR 127 OR 128 OR 129 OR 130 OR 131 OR 132

134. 108 OR 133

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135. 34 AND 134

136. 135 AND ("1986/01/01"[Date - Publication] : "3000"[Date - Publication])

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PRISMA-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) 2015 checklist: recommended items to

address in a systematic review protocol*

Section and topic Item No Checklist item

ADMINISTRATIVE INFORMATION

Title:

Identification 1a Identify the report as a protocol of a systematic review

Update 1b If the protocol is for an update of a previous systematic review, identify as such

Registration 2 If registered, provide the name of the registry (such as PROSPERO) and registration number

Authors:

Contact 3a Provide name, institutional affiliation, e-mail address of all protocol authors; provide physical mailing address of

corresponding author

Contributions 3b Describe contributions of protocol authors and identify the guarantor of the review

Amendments 4 If the protocol represents an amendment of a previously completed or published protocol, identify as such and list changes;

otherwise, state plan for documenting important protocol amendments

Support:

Sources 5a Indicate sources of financial or other support for the review

Sponsor 5b Provide name for the review funder and/or sponsor

Role of sponsor or funder 5c Describe roles of funder(s), sponsor(s), and/or institution(s), if any, in developing the protocol

INTRODUCTION

Rationale 6 Describe the rationale for the review in the context of what is already known

Objectives 7 Provide an explicit statement of the question(s) the review will address with reference to participants, interventions,

comparators, and outcomes (PICO)

METHODS

Eligibility criteria 8 Specify the study characteristics (such as PICO, study design, setting, time frame) and report characteristics (such as years

considered, language, publication status) to be used as criteria for eligibility for the review

Information sources 9 Describe all intended information sources (such as electronic databases, contact with study authors, trial registers or other

grey literature sources) with planned dates of coverage

Search strategy 10 Present draft of search strategy to be used for at least one electronic database, including planned limits, such that it could be

repeated

Study records:

Data management 11a Describe the mechanism(s) that will be used to manage records and data throughout the review

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Selection process 11b State the process that will be used for selecting studies (such as two independent reviewers) through each phase of the

review (that is, screening, eligibility and inclusion in meta-analysis)

Data collection process 11c Describe planned method of extracting data from reports (such as piloting forms, done independently, in duplicate), any

processes for obtaining and confirming data from investigators

Data items 12 List and define all variables for which data will be sought (such as PICO items, funding sources), any pre-planned data

assumptions and simplifications

Outcomes and prioritization 13 List and define all outcomes for which data will be sought, including prioritization of main and additional outcomes, with

rationale

Risk of bias in individual studies 14 Describe anticipated methods for assessing risk of bias of individual studies, including whether this will be done at the

outcome or study level, or both; state how this information will be used in data synthesis

Data synthesis 15a Describe criteria under which study data will be quantitatively synthesised

15b If data are appropriate for quantitative synthesis, describe planned summary measures, methods of handling data and

methods of combining data from studies, including any planned exploration of consistency (such as I2, Kendall’s τ)

15c Describe any proposed additional analyses (such as sensitivity or subgroup analyses, meta-regression)

15d If quantitative synthesis is not appropriate, describe the type of summary planned

Meta-bias(es) 16 Specify any planned assessment of meta-bias(es) (such as publication bias across studies, selective reporting within studies)

Confidence in cumulative evidence 17 Describe how the strength of the body of evidence will be assessed (such as GRADE)

* It is strongly recommended that this checklist be read in conjunction with the PRISMA-P Explanation and Elaboration (cite when available) for important

clarification on the items. Amendments to a review protocol should be tracked and dated. The copyright for PRISMA-P (including checklist) is held by the

PRISMA-P Group and is distributed under a Creative Commons Attribution Licence 4.0.

From: Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart L, PRISMA-P Group. Preferred reporting items for systematic review and

meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015 Jan 2;349(jan02 1):g7647.

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Functional outcome after Mason II-III radial head and neck



Journal: BMJ Open

Manuscript ID bmjopen-2016-013022.R2


Date Submitted by the Author: 17-Nov-2016

Complete List of Authors: Hagelberg, Mårten; Karolinska Institutet Department of Clinical Sciences Danderyd Hospital, Thune, Alexandra; Karolinska Institutet, Department of clinical sciences at Danderyd hospital Krupic, Ferid; Goteborgs universitet Sahlgrenska Akademin Salomonsson, Björn; Karolinska Institutet Department of Clinical Sciences Danderyd Hospital Sköldenberg, Olof; Karolinska Institutet, Department of clinical sciences at Danderyd hospital


Surgery


Keywords: Radial head and neck fractures, Elbow & shoulder < ORTHOPAEDIC & TRAUMA SURGERY, Treatment outcome, Systematic review protocol


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1

FunctionaloutcomeafterMasonII-III




Mårten Hagelberg1, Alexandra Thune1, Ferid Krupic2, Björn Salomonsson1, Olof Sköldenberg1

1 Karolinska Institute, Department of Clinical Sciences at Danderyd Hospital, Stockholm, Sweden.

2University of Gothenburg Institute of Clinical Sciences, Sahlgrenska Akademy, University of

Gothenburg, Mölndal, Sweden.


Sciences, Unit of Orthopaedics, Karolinska Institute at Danderyd Hospital, S-182 88 Danderyd,

Sweden. Tel +46-8-6555000. Fax +46-8-7551476.




Word count: 2172

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2

ABSTRACT

Introduction



either conservative or surgical. There is no absolute cons

functional outcome after mason ii-iv radial head and neck€¦ · radial head and neck fractures:...

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