Faculty of Medicine Ramathibodi Hospital Mahidol ... · of both internal fixation methods (DHS and...

Faculty of Medicine Ramathibodi Hospital,

Mahidol University

RACE 698/8 Dissertation

Master of Science Program in Medical Epidemiology

(International Program)

Natthapong Hongku

ID 5936423

Title: Fracture Fixation versus Hemiarthroplasty for Unstable

Intertrochanteric Fractures in Elderly Patients, Which one is lower

morbidity and mortality rates? : Systematic Review and Network Meta-

Analysis of Randomized Controlled Trials

Research Proposal

1 |

Contents INVESTIGATOR AND SUPERVISORS 3 1. BACKGROUND AND RATIONALE 4 1.1 Background and Rationale 1.1.1 Magnitude of problem 1.1.2 Disease burden or impacts 1.1.3 Treatment and goals of treatment 1.2 Literature review and rationale for conducting study 1.3 Research Question 1.4 Research Objectives 2. METHODOLOGY 9 2.1 Study design

2.2 Location of studies 2.3 Selection of studies

2.4 Data extraction 2.5 Risk of bias assessment 2.6 Statistical Analysis 2.6.1 Direct meta-analysis 2.6.2 Network meta-analysis 2.7 Time Frame ACKNOWLEDGEMENTS 16 REFERENCES 17 FIGURES 21-23 APPENDICES

Appendix 1: Search term and results 24 Appendix 2: Data extraction forms 26 Appendix 3: Risk bias assessment forms 30 Appendix 4: Timeline for research 32

2 |

FRACTURE FIXATION VERSUS HEM IARTHROPLASTY FOR

UNSTABLE INTERTROCHANTERIC FRACTURE IN ELDERLY

PATIENTS, WHICH ONE IS LOWER MORBIDITY AND MORTALITY

RATES? : SYSTEMATIC REVIEW AND NETWORK METAANALYSIS

OF RANDOMIZED CONTROLLED TRIALS

Investigators and Affiliation:

1. Natthapong Hongku

Department of Orthopedic, Faculty of Medicine Vajira hospital, Navamindradhiraj University

Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi

Hospital, Mahidol University

E-mail: [email protected]

2. Lertkong Nitiwarangkul

Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi


Department of Orthopedic, Police General Hospital


Supervisors:

1. Sasivimol Rattanasiri, Assistant Professor, PhD


2. Patarawan Woratanarat, Associate Professor, PhD


3. Ammarin Thakkinstian, Professor, PhD


Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi


3 |

mailto:[email protected]

mailto:[email protected]

CHAPTER 1

BACKGROUND AND RATIONALE

1.1 Background and rationale

1.1.1 Magnitude of problem

Elderly populations are increasing due to improvement in health care systems

following with rising of population’s life expectancy. One of the most important health

problems in elderly populations is osteoporosis, which led to more than 90% of the fragility

fracture after simple fall especially fracture around the hip joint (1). The incidence of

osteoporotic hip fracture has been forecasted to be increased doubling in each decade of life

after age 50 years, and it was common in female than male (2, 3).

1.1.2 Disease burden or impacts

There are three types of osteoporotic hip fracture base on location of fracture, i.e.,

intracapsular neck fracture, intertrochanteric fracture, and sub trochanteric fracture (4) as

shown in figure 1. Intertrochanteric fracture is the most common osteoporotic hip fracture

which commonly occurred in patients aged 70 years or older. A mortality rate after

intertrochanteric fracture was varied but still as high as 14 to 36%(5, 6); this was due to their

underlying disease and independent status in carrying out daily life activity(7). In addition, a

lot of major morbidity occurred after fracture including pressure sore, pneumonia, urinary

tract infection, and venous thromboembolism. Furthermore, 25% of patients might need long-

term life cares, and 50% of them need assistance in daily life activity (8). These morbidities

could be prevented by early mobilization, early weight bearing, and early return to pre-injury

activity level as soon as possible

4 |

Intertrochanteric fracture is additionally classified into stable and unstable fractures

depend on location (i.e., lesser or greater trochanter), patterns of fracture line, and

configuration of fracture. The unstable intertrochanteric fractures are defined as fracture of

lesser trochanter (9), reverse oblique fracture pattern with presence of comminution of

posteromedial fragment (10, 11), and breaking of lateral cortex (12) as shown in figure 2.

Conversely, the stable fractures are defined as non-displacement and non-comminution of

fracture site.

1.1.3 Treatment and goals of treatment

Two treatment management options are available for intertrochanteric fracture (i.e.,

operative and non-operative treatment managements). Choosing appropriated treatments

depend on various factors such as patient’s status, their co-morbidity and expectations.

Patients with severe co-morbidity, high risk of surgery, and bedridden status may be more

appropriated to receive non-operative treatments. Contrastingly, patients without these

conditions may be suit with operation treatments, which aimed as anatomical reduction with

stable fixation and promote fracture healing leading to early mobilization with appropriated

weight bearing ambulation.

The surgical options for reduction and internal fixation are divided into extra-

medullary devices (i.e. dynamic or sliding hip screw: DHS) and intra-medullary devices (i.e.

proximal femoral nail: PFN) as shown in figure 3. Not only type of implant, but also bone

quality in osteoporotic fracture play a role on operation results. For stable intertrochanteric

fracture, internal fixation either extra or intra-medullary device might yielded good results

but not for unstable intertrochanteric osteoporotic fracture (13) which might be due to

5 |

difficulty in maintain a stable fixation. Moreover the reoperation due to implant failure may

occur in patients who could not protect of full weight bearing after operation (14, 15)

Recently, bipolar hemiarthroplasty or total hip arthroplasty (THA) for femoral neck

fracture which is another common hip fracture in elderly patients showed good clinical result

in term of clinical outcome and lower reoperation rate (16) as shown in figure 4 but were still

controversial for unstable intertrochanteric fracture especially in osteoporotic elderly

populations.

The Advantages of internal fixation fracture with intramedullary devices in

intertrochanteric fracture included less soft tissue trauma from minimal invasive surgical

techniques, less blood loss (17), no complications related with prosthesis such as prosthetic

dislocation or periprosthetic fracture. However, previously evidence showed that the internal

fixation were risk to fail for fracture fixation, loss of fracture reduction, femoral head or

fracture site collapse (18) as shown in figure 5. The most acceptable advantages of

hemiarthroplasty for unstable intertrochanteric fracture were allowing to full weight bearing

immediately postoperative, in which patients could early ambulation (19), avoid bony

collapse at fracture site (20), problems of fracture malunion or nonunion as shown in figure 6

and also prevent any complication due to prolong immobilization such as pressure sore,

pneumonia, deep vein thrombosis. But the complications related to the difficult of procedure

were also reported including increase operative time, increase intraoperative blood loss, need

more surgical experienced, high risk of prosthetic dislocation and periprosthetic fracture (21).

6 |

1.2 Literature review and rationale for conducting study

Results of management options for unstable intertrochanteric fractures were still

controversial. A recently systematic review and meta- analysis (22) combined data from 2

randomized controlled trials (RCTs) and 8 retrospective cohort studies, which demonstrated

that both hemiarthroplasty and fracture fixation were not significant different in term of

overall mortality, reoperation rate, and complications; but hemiarthroplasty was superior in

functional outcomes especially earlier mobilization compared to fracture fixation.

However, this review was mainly based on observational studies which prone to bias results.

The questions of which surgical treatment management was the best in term of high efficacy

and low complications for unstable intertrochanteric fractures in elderly patients was still

unanswerable.

There were few RCTs published (23, 24) since then we therefore, updated a

systematic review and performed network meta-analysis to assess efficacy and complications

of both internal fixation methods (DHS and PFN) and hemiarthroplasty. Failure and

reoperation were compared across three surgical treatment managements. In addition, the

function score measured by Harris Hip Score (HHS) was also compared. Finally, probability

being best management (i.e. low complications and high functions) was estimated and rank

accordingly.

7 |

1.3 Research question

Among all of the available surgical treatment for unstable intertrochanteric fractures

in elderly patients, which one between fracture fixations and hemiarthroplasty will provide

better clinical results in term of lower complication events?

1.4 Research objectives

• To compare surgical complication results such as failure and re-operation rates of

surgical treatment between fracture fixation and hemiarthroplasty for unstable

intertrochanteric fractures in elderly patients

• To compare clinical outcomes such as Harris hip score between fracture fixation and

hemiarthroplasty for unstable intertrochanteric fracture in elderly patients

8 |

CHAPTER 2

METHODOLOGY

2.1 Study design

Systematic review with direct and network meta-analysis

2.2 Location of studies

2.2.1 Sources

The relevant studies will be searched by two reviewers (N.H. and L.N.) using

MEDLINE via PubMed (www.ncbi.nlm.nil.gov/pubmed), SCOPUS via Scopus

(www.scopus.com) and reference lists from selected articles and previous meta-analysis

articles.

2.2.2 Search strategy

Search terms will be constructed according to population (P), intervention (I) and

comparator (C) filtering for only RCT. The search terms for outcomes (O) will be ignored

because we would like to retrieve outcomes as much as possible given interested

interventions. Search terms for P, I, and C are as follows: for P “Unstable* intertrochant*”,

“Unstable intertrochant*”*”, “Unstable *intertrochant*”*”: for I and C, Fixation* for any

type of fracture fixations, “Dynamic hip screw” or “Sliding hip screw” in term of first

specific type of fixation, “Proximal femoral nail” or “Intramedullary nail” in term of second

specific type of fixation, “Gamma nail” in term of third specific type of fixation, “Medoff

plate” in term of fourth specific type of fixation, “Less Invasive Stabilization System” or

LISS in term of last specific type of fixation, and Hemiarthroplasty for comparators.

These search terms will be combined within and between domains using conjunction “OR”

and “AND”, respectively as show in Appendix 1.

9 |

http://www.ncbi.nlm.nil.gov/pubmed

http://www.scopus.com/

2.3 Selection of studies

All relevant studies from both database will be imported into the Endnote program

version 8.0. RCTs published in English will be included if they met following criteria:

• Studies in elderly patients aged 60 years or older who had unstable intertrochanteric

fractures.

• Studies which compared different technique of fracture fixations and hemiarthroplasty

(cementless or cemented)

• Studies which reported at least one of following outcomes: mortality, any

complications (e.g., reoperation and/or fixation failure), clinical outcomes such as

operative time, intra-operative blood loss, length of hospital stays, Harris hip score,

and mobility score.

The studies were excluded if they included patient with bilateral fracture or duplicated

report of the same studies patients, and insufficient data for pooling after three times contact

the author.

10 |

2.4 Data extraction

The data will be extracted by two reviewers (N.H. and L.N.) independently using

standardized data extraction forms. The difference of extracted results will be discussed and

consensus by senior and supervisor (A.T.). The data extraction forms consisted of four

domains, i.e. general study’s information (i.e., name of title, author, study setting, and name

of journal, publication year, volume and page of studies); study’s characteristics (i.e., study

design, treatment management, and outcomes); patient’s characteristics (i.e., mean age,

gender, side, type of fracture and classification, bone disease by Singh index, American

Society of Anesthesiologists (ASA) grade, time to surgery periods, follow-up time, and

number of loss to follow-up patients); and data for pooling for both dichotomous and

continuous outcomes. Aggregated data of contingency cells for interventions and outcomes

will be extracted. Mean values along with standard deviation for continuous outcomes will be

also extracted. Details of data extraction forms were demonstrated in Appendix 2

Interventions

The interested intervention were fracture fixation managements and hemiarthroplasty

including cementless and cemented types.

Outcome of interests

The primary interested outcomes were rate of failure and reoperation after performed

operation, other complications including mortality rate, medical and surgical complications.

The secondary interested outcomes were functional score (HHS) at less and more than 3

months, length of hospital stay, and operative times.

11 |

Mortality was due to surgery if it was death within 6 weeks. Reoperation was defined

accordingly to criteria used by the original studies. Briefly, patients required to repeat

operation if they had dislocation of prosthesis or revised from internal fracture fixation to

joint replacement surgery. Failure was defined as patients who had any problems related

with prosthesis or implant (i.e., avascular necrosis of femoral head, hardware cutting-off,

mal- or non-union of fracture, deformity of bone, breakage of screw, re-displacement or

collapse of fracture around implant, and shortening of fracture site). Medical complication

was defined as complications due to medical problems within 6 weeks post-operatively. For

example, patients were pulmonary, cardiovascular or neurological complication, pressure

sore, deep vein thrombosis, urinary tract infection, thrombophlebitis, sepsis. Surgical

complication was defined superficial or deep wound infection, and dislocation of hip

prosthesis within 6 weeks after surgery.

2.5 Risk of bias assessment

The risk of bias was independently assessed for each RCT by two reviewers (N.H and

L.N.) using Cochrane risk of bias assessment tool for RCTs. Six domains were assessed

including random sequence generation, conceal treatment allocation, blinding of patients and

outcome assessors, incomplete data, and outcome assessment selective outcome report, and

other biases. Each domain was graded as ‘yes’ and ‘no’ if there was evidence of low and high

risk of bias, respectively. If there was in sufficient information to judge, it was classified as

‘unclear’. The details of risk of bias assessment forms were presented in Appendix 3.

12 |

2.6 Statistical analysis plan

2.6.1 Direct meta-analysis

For dichotomous outcomes (i.e., mortality, reoperation, failure of the operation,

medical and surgical complication events data of surgical treatment options), a relative

treatment effects (i.e., risk ratios, RRs) will be estimated for individual studies. For the

continuous outcomes measured using the same scales (i.e., operative time, intra-operative

blood loss, and length of hospital stay), mean differences (MD) will be estimated otherwise

the standardized mean difference (SMD) will be estimated for HHS and mobility scores.

Then RRs, MDs and SMDs will be pooled across studies using appropriate pooling models

(fixed-effect or random effect model) depend on whether treatment effects were

heterogeneous. If not, a fixed-effect model by Inverse-variance method will be used,

otherwise a random-effect model by DerSimonian and Laird method will be used.

Heterogeneity was present if the Cochrane’s Q statistic was significant (P value ≤ 0.1) or the

I2 statistic ≥ 25%. The possible source of heterogeneity will be explored using meta-

regression analysis model by fitting clinical factors (i.e., mean age, gender, type of fracture

classification, follow up time, number of loss follow up) or methodological factors (i.e., type

of outcome measurement, definition of each outcome, setting of the study) one by one in the

meta-regression model. If the including that factors resulted in decreasing degree of

heterogeneity (I2), subgroup analysis will be performed accordingly.

Publication bias was assessed using funnel plot and Egger test. If one of them showed

asymmetry. A contour enhanced funnel plot was used for distinguish asymmetry of the funnel

was from publication bias or heterogeneity.

13 |

2.6.2 Network meta-analysis

Network meta-analysis with two-stage approach was applied to indirectly compare

relative treatment effects across studies. Firstly, regression analysis will be applied with

appropriated link function depend on type of interested outcomes (i.e., logit link function for

dichotomous outcomes, identity link for continuous outcomes), to estimate relative effect for

each study. The interested interventions was coded as 1, 2, and 3 for DHS, PFN, and

hemiarthroplasty as the reference when fitting. Second, the multivariate meta-analysis will be

applied to pool relative intervention effects [e.g., log (RR) or MDs] across studies using a

consistency model. The multiple comparison of DHS versus PFN, DHS versus HA, and PFN

versus HA will be then estimated.

The inconsistency assumption, i.e., agreement of direct and indirect treatment effects

was then checked using design-by-treatment interaction inconsistency model. In addition,

transitivity was indirectly explored by assessing distribution of factors effect on interested

outcome between intervention arms. These included mean age, type of fracture classification,

definition of outcomes, study setting, follow up period, and risk of bias assessment. If these

characteristics were not much different across intervention comparisons, transitivity may be

assumed. Probability of being the best intervention was estimated and rank using surface

under the cumulative ranking curve (SUCRA) and Rankogram plot. Publication bias for

network meta-analysis was assessed using adjusted funnel plot. All statistical analysis will be

performed using STATA software program version 14.2. P value of less than 0.05 will be

considered as significance. However, for the heterogeneity test, the significant level P value

less than 0.1 will be use.

14 |

2.7 Time Frame

The timeline of this systematic review and network meta-analysis is demonstrated in

Appendix 4.

15 |

ACKNOWLEDGEMENTS

This research proposal is a part of the dissertation for Natthapong Hongku’s training in M.Sc

(Medical Epidemiology), Faculty of Medicine Ramathibodi Hospital and Faculty of Graduate

Studies, Mahidol University.

Funding source: none

16 |

Reference

1. Baker SP, Harvey AH. Fall injuries in the elderly. Clinics in geriatric medicine.

1985;1(3):501-12.

2. Gallagher JC, Melton LJ, Riggs BL, Bergstrath E. Epidemiology of fractures of the

proximal femur in Rochester, Minnesota. Clinical orthopaedics and related research.

1980(150):163-71.

3. Hedlund R, Lindgren U. Trauma type, age, and gender as determinants of hip fracture.

Journal of orthopaedic research : official publication of the Orthopaedic Research Society.

1987;5(2):242-6.

4. Zuckerman JD. Hip fracture. The New England journal of medicine. 1996;334(23):1519-25.

5. Kesmezacar H, Ayhan E, Unlu MC, Seker A, Karaca S. Predictors of mortality in elderly

patients with an intertrochanteric or a femoral neck fracture. The Journal of trauma.

2010;68(1):153-8.

6. Vestergaard P, Rejnmark L, Mosekilde L. Has mortality after a hip fracture increased?

Journal of the American Geriatrics Society. 2007;55(11):1720-6.

7. Blomfeldt R, Tornkvist H, Eriksson K, Soderqvist A, Ponzer S, Tidermark J. A randomised

controlled trial comparing bipolar hemiarthroplasty with total hip replacement for displaced

intracapsular fractures of the femoral neck in elderly patients. The Journal of bone and joint

surgery British volume. 2007;89(2):160-5.

17 |

8. Lu-Yao GL, Keller RB, Littenberg B, Wennberg JE. Outcomes after displaced fractures

of the femoral neck. A meta-analysis of one hundred and six published reports. The Journal of

bone and joint surgery American volume. 1994;76(1):15-25.

9. Barton TM, Gleeson R, Topliss C, Greenwood R, Harries WJ, Chesser TJ. A comparison

of the long gamma nail with the sliding hip screw for the treatment of AO/OTA 31-A2 fractures of

the proximal part of the femur: a prospective randomized trial. The Journal of bone and joint

surgery American volume. 2010;92(4):792-8.

10. Dimon JH, Hughston JC. Unstable intertrochanteric fractures of the hip. The Journal of

bone and joint surgery American volume. 1967;49(3):440-50.

11. Evans EM. The treatment of trochanteric fractures of the femur. The Journal of bone and

joint surgery British volume. 1949;31b(2):190-203.

12. Gotfried Y. The lateral trochanteric wall: a key element in the reconstruction of unstable

pertrochanteric hip fractures. Clinical orthopaedics and related research. 2004(425):82-6.

13. Bannister GC, Gibson AG, Ackroyd CE, Newman JH. The fixation and prognosis of

trochanteric fractures. A randomized prospective controlled trial. Clinical orthopaedics and

related research. 1990(254):242-6.

14. Kayali C, Agus H, Ozluk S, Sanli C. Treatment for unstable intertrochanteric fractures in

elderly patients: internal fixation versus cone hemiarthroplasty. Journal of orthopaedic surgery

(Hong Kong). 2006;14(3):240-4.

15. Kim SY, Kim YG, Hwang JK. Cementless calcar-replacement hemiarthroplasty

compared with intramedullary fixation of unstable intertrochanteric fractures. A prospective,

18 |

randomized study. The Journal of bone and joint surgery American volume. 2005;87(10):2186-

92.

16. Blomfeldt R, Tornkvist H, Ponzer S, Soderqvist A, Tidermark J. Comparison of internal

fixation with total hip replacement for displaced femoral neck fractures. Randomized, controlled

trial performed at four years. The Journal of bone and joint surgery American volume.

2005;87(8):1680-8.

17. Boldin C, Seibert FJ, Fankhauser F, Peicha G, Grechenig W, Szyszkowitz R. The

proximal femoral nail (PFN)--a minimal invasive treatment of unstable proximal femoral fractures:

a prospective study of 55 patients with a follow-up of 15 months. Acta orthopaedica

Scandinavica. 2003;74(1):53-8.

18. Jones HW, Johnston P, Parker M. Are short femoral nails superior to the sliding hip

screw? A meta-analysis of 24 studies involving 3,279 fractures. International orthopaedics.

2006;30(2):69-78.

19. Davison JN, Calder SJ, Anderson GH, Ward G, Jagger C, Harper WM, et al. Treatment

for displaced intracapsular fracture of the proximal femur. A prospective, randomised trial in

patients aged 65 to 79 years. The Journal of bone and joint surgery British volume.

2001;83(2):206-12.

20. Green S, Moore T, Proano F. Bipolar prosthetic replacement for the management of

unstable intertrochanteric hip fractures in the elderly. Clinical orthopaedics and related

research. 1987(224):169-77.

19 |

21. Geiger F, Zimmermann-Stenzel M, Heisel C, Lehner B, Daecke W. Trochanteric fractures

in the elderly: the influence of primary hip arthroplasty on 1-year mortality. Archives of

orthopaedic and trauma surgery. 2007;127(10):959-66.

22. Yoo JI, Ha YC, Lim JY, Kang H, Yoon BH, Kim H. Early Rehabilitation in Elderly after

Arthroplasty versus Internal Fixation for Unstable Intertrochanteric Fractures of Femur:

Systematic Review and Meta-Analysis. Journal of Korean medical science. 2017;32(5):858-67.

23. Mansukhani SA, Tuteja SV, Kasodekar VB, Mukhi SR. A Comparative study of the

Dynamic Hip Screw, the Cemented Bipolar Hemiarthroplasty and the Proximal Femoral Nail for

the Treatment of Unstable Intertrochanteric Fractures. Journal of clinical and diagnostic

research : JCDR. 2017;11(4):Rc14-rc9.

24. Hussain N. Management of complex intertrochanteric fractures of the femur in elderly

patients – dynamic hip screws or proximal femoral nails or arthroplasty International Journal of

Research in Orthopaedics 2017; | Vol 3( | Issue 4 ):1-5.

20 |

Figure 1: Types of osteoporotic hip fracture classified as intracapsular femoral neck, intertrochanteric, and subtrochanteric fracture (from left to right)

Figure 2: Unstable intertrochanteric fracture as fracture of lesser trochanter (left), reverse oblique fracture pattern with presence of comminution of posteromedial fragment (middle), and breaking of lateral cortex (right)

21 |

Figure 3: The method of reduction and fixation of intertrochanteric fracture with extra-medullary device: dynamic or sliding hip screw (left) and intra-medullary device: proximal femoral nail (right)

Figure 4: Pre and postoperative radiographic of patients who presented with fracture of the right femoral neck performed total hip replacement (middle) and bipolar hemiarthroplasty (right) and showed good clinical outcome.

22 |

Figure 5: Failure of internal fixation for unstable intertrochanteric fracture with dynamic hip screw show loss reduction and cut-out of screw (left). With proximal femoral nail show collapse of poor quality bone at fracture site (right)

Figure 6: Pre and postoperative radiographic of unstable intertrochanteric fracture patient treated with cemented bipolar hemiarthroplasty

23 |

Appendix 1: Search term and results

a) Search results from PubMed Domains

Search Terms Results

Populations (P)

#1 "unstable* intertrochant*" 71,183 #2 "unstable intertrochant*" 71,154 #3 “unstable *intertrochant*” 71,154 #4 #1 OR #2 OR #3 71,183

Interventions and Comparators (IC)

#5 Fixation* 188,983 #6 “Dynamic hip screw” 673 #7 “Sliding hip screw” 252 #8 #6 OR #7 902 #9 “Proximal femoral nail” 302 #10 "Proximal* nail” 224 #11 “Intramedullary nail” 2,040 #12 #9 OR #10 OR #11 2,528 #13 "Gamma nail" 354 #14 "Medoff plate” 12 #15 "Less Invasive Stabilization System" 127 #16 LISS 3,662 #17 #15 OR #16 3,685 #18 Hemiarthroplasty 2,470 #19 #5 OR #8 OR #12 OR #13 OR #14 OR #17 OR #18 194,982

Filters (Study design)

#20 "Randomized controlled trial" 453,509 #21 "Clinical trial" 640,333 #22 "Randomized trial" 36,559 #23 Random* 1,120,653 #24 #20 OR #21 OR #22 OR #23 1,468,184

Populations, Interventions and Comparators, Filters

#25

#4 AND #19 AND #24

479

24 |

b) Search results from SCOPUS

Domains

Search Terms Results

Populations (P)

#1 "unstable* intertrochant*" 1,398 #2 "unstable intertrochant*" 1,938 #3 “unstable *intertrochant*” 1,400 #4 #1 OR #2 OR #3 2,032

Interventions and Comparators (IC)

#5 Fixation* 567,139 #6 “Dynamic hip screw” 2,481 #7 “Sliding hip screw” 1,282 #8 #6 OR #7 2,950 #9 “Proximal femoral nail” 1,185 #10 "Proximal* nail” 570 #11 “Intramedullary nail” 10,328 #12 #9 OR #10 OR #11 11,335 #13 "Gamma nail" 1,916 #14 "Medoff plate” 16 #15 "Less Invasive Stabilization System" 1,083 #16 LISS 299,981 #17 #15 OR #16 299,750 #18 Hemiarthroplasty 8,189 #19 #5 OR #8 OR #12 OR #13 OR #14 OR #17 OR #18 797,833

Filters (Study design)

#20 "Randomized controlled trial" 1,375,028 #21 "Clinical trial" 2,109,384 #22 "Randomized trial" 954,550 #23 Random* 5,005,941 #24 #20 OR #21 OR #22 OR #23 5,822,362

Populations, Interventions and Comparators, Filters

#25

#4 AND #19 AND #24

924

25 |

Appendix 2: Data extraction forms

Data extraction form (1)

Fracture Fixation versus Hemiarthroplasty for Unstable Intertrochanteric

Fractures in Elderly Patients, Which one is lower morbidity and mortality rates?

: Systematic Review and Network Meta-Analysis of Randomized Controlled

Trial Study ID …………………………..

Part 1: General study information

1. Title

2. First author name

3. Study setting/Country

4. Journal name

5. Year of publication

6. Volume

7. Page

Reviewer Natthapong Lertkong

DEF version Date

26 | P a g e





Trials Study ID …………………………..

Part 2: General study characteristics

Study design

RCT

Treatment interventions

Dynamic hip screw Proximal femoral nail Hemiarthroplasty

Type of outcomes

Mortality Reoperation Failure operation Medical complications ………………………………………………………… Surgical complications ………………………………………………………… Harris hip score at less than 3 months Harris hip score at more than 3 months Operative time Length of hospital stay


DEF version Date

27 | P a g e






Part 3: General patient characteristics

Characteristics

Intervention

Overall

DHS

PFN

Hemiarthroplasty

Number

Age (Mean)

Sex-Male: Female

(% male)

Side-Right: Left

(% Right side)

Type of fracture Classification

Percentage of unstable type*

Type of anaesthesia - GA:RA

(%GA)

ASA grade

Percentage of ASA class > 2

Follow up time (month)

Number of loss follow up

* Unstable type defined as fracture classification AO 31A2.2 – AO31A3.3 or Evan type II, III, IV, V


DEF version Date

28 | P a g e

Data extraction form (4) Fracture Fixation versus Hemiarthroplasty for Unstable Intertrochanteric




Part 4: The pooling Data for dichotomous outcomes

Interventions

Mortality Reoperation Failure Medical complications

Surgical complications

N no. (%)

N no. (%)

N no. (%)

N no. (%)

N no. (%)

Dynamic hip screw

Proximal femoral nail

Hemiarthroplasty

Part 5: The pooling data for continuous outcomes

Intervention Operative time Intra-operative blood loss

Hospitalization Harris Hip Score Mobility Score

n Mean SD n Mean SD n Mean SD n Mean SD n Mean SD

Dynamic hip screw

Proximal femoral nail

Hemiarthroplasty


DEF version Date

29 | P a g e

Appendix 3: Risk bias assessment form (1) Fracture Fixation versus Hemiarthroplasty for Unstable Intertrochanteric Fractures in Elderly Patients, Which one is lower morbidity and mortality rates? : Systematic Review and Network Meta-Analysis of Randomized Controlled Trials

Study ID ………………………….. Domain Question Assessment Selection bias

1. Was the allocation sequence generated adequately?

Yes No Unclear

2. Were participants analyzed within the groups they were originally assigned to?

Yes No Unclear

3. Was the allocation of treatment adequately?

Yes No Unclear

4. Did the study apply inclusion/exclusion criteria uniformly to all comparison groups?

Yes No Unclear

Performance bias

1. Did the study blinding of participant / assessors

Yes No Unclear

Attrition bias

1. Were missing data handled appropriately (e.g., intention-to-treat analysis and imputation)?

Yes No Unclear

Detection bias

1. Was the length of follow-up different between the groups?

Yes No Unclear

2. Were interventions/exposures assessed/defined using valid and reliable measures?

Yes No Unclear

3. Were outcomes assessed using valid and reliable measures?

Yes No Unclear

Reporting bias

1. Were the potential outcomes prespecified by the researchers?

Yes No Unclear

2. Are all pre-specified outcomes reported?

Yes No Unclear

If answer is “Yes” in all domains would place a study at “Low Risk of Bias” If answer is “No” in any of the domains would place a study at “High Risk of Bias” If answer is “Unclear” in any of the domains would place the study at “Unclear Risk of Bias”

Reviewer Natthapong Lertkong RAF version Date

30 | P a g e

Risk bias assessment form (2)





Domain Low risk High risk Unclear Quote; Comment

Selection bias

1. Random sequence generation

2. Allocation concealment

Performance bias

1. Blinding of participants

2. Blinding of assessors

Attribution bias

Incomplete outcome data

Detection bias

1. Blinding of outcome assessment

Reporting bias

1. Selective outcome reporting


RAF version Date .

31 | P a g e

Appendix 4: Timeline of research

Item TOR Nov Dec Jan Feb Mar Apr 1. Develop research proposal

2. Prospero registration

3. Defend research proposal

4. Conduct research

5. Develop 1st manuscript

• Introduction

• Methods

• Results

• Discussion

6. Submit 1st manuscript (RACE 618)

systematic review

7. Write thesis

• Chapter 1: Introduction

• Chapter 2: Methods

• Chapter 3: Results

• Chapter 4: Discussion

8. Defend thesis

32 | P a g e

Faculty of Medicine Ramathibodi Hospital Mahidol ... · of both internal fixation methods (DHS and...

Documents

Transcript of Faculty of Medicine Ramathibodi Hospital Mahidol ... · of both internal fixation methods (DHS and...